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NCT01013649 · CITED IN SOURCE DOCUMENTS

Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2026-02-23

This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival (Percentage of Participants Alive) [Phase II]

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outcome · POSTED

Overall Survival (Percentage of Participants Alive) [Phase III]

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outcome · POSTED

Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase II]

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outcome · POSTED

Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase III]

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outcome · POSTED

Number of Participants by Highest Grade Adverse Event Reported (Phase II)

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outcome · POSTED

Number of Participants by Highest Grade Adverse Event Reported (Phase III)

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outcome · POSTED

Overall Survival (Percentage of Participants Alive) by Baseline Fatigue Group

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outcome · NOT POSTED

Determination of National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue and Overall Survival

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outcome · NOT POSTED

Frequency of Objective Criteria of Resectability as Measured by Preoperative Imaging

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outcome · POSTED

Overall Survival (Percentage of Participants Alive) [Phase III] by Sex

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outcome · POSTED

Overall Survival (Percentage of Participants Alive) [Phase III] by Ethnicity

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outcome · POSTED

Overall Survival (Percentage of Participants Alive) [Phase III] by Race

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e., removal of all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy; patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible * The operating surgeon must document in the operative note that a complete gross excision of the primary tumor was achieved; the pathology report must include documentation of the margin status and the size of the tumor; the pathology report must also include the status of the three major margins-bile duct, pancreatic parenchyma, and retroperitoneal (uncinate) * For patients who have not started their chemotherapy prior to registration, the interval between definitive tumor-related surgery and 1st step registration must be between 21-70 days; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, the interval between definitive tumor-related surgery and day one of adjuvant chemotherapy must be between 21-77 days * Patients will be staged according to the 6th edition American Joint Committee on Cancer (AJCC) staging system with pathologic stage T1-3, N0-1, M-0 being eligible. Pathologic reporting using the College of American Pathologists (CAPS) format is strongly encouraged * Age \>= 18 * Zubrod performance status 0 or 1 * Complete history and physical examination including weight and Zubrod status within 31 days of study entry (or within 31 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration) * Before starting therapy the patient should be able to maintain adequate oral nutrition of \>= 1500 calories estimated caloric intake per day and be free of significant nausea and vomiting * Complete blood count (CBC)/differential obtained within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration) * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelets \>= 100,000/mm\^3 * Hemoglobin \>= 8.0 g/dL (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable) * Post resection serum cancer antigen (CA)19-9 =\< 180 units/mL AND prior to any systemic treatment * Serum total bilirubin =\< twice the institutional upper limit of normal (ULN) within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration) * Creatinine levels =\< twice the institutional upper limit of normal within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration) * Serum glutamic oxaloacetic transaminase (SGOT) must be =\< 2.5 x the institutional upper limit of normal within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration) * Negative serum pregnancy test for women of childbearing potential within 14 days of study registration * Abdominal/pelvic CT scan with contrast is preferred; abdominal CT alone is acceptable only if insurance restrictions are experienced; chest CT/x-ray (CT of chest preferred) within 31 days of registration on study (or within 31 days prior to day 1 of chemo post-surgery for those patients having started chemotherapy prior to first step registration); patients allergic to IV contrast can have MRI of the abdomen/pelvis instead * Signed study-specific informed consent * Consultation, agreement, and documentation in the patient's chart by a radiation oncologist that patient is suitable to receive radiotherapy per this protocol * Women of childbearing potential and male participants must practice adequate contraception * Patients with active human immunodeficiency virus (HIV) infection are eligible if their cluster of differentiation (CD)4 count is \> 499/cu mm and their viral load is \< 50 copies/ml; use of highly active antiretroviral treatment (HAART) is allowed Exclusion Criteria: * Patients with non-adenocarcinomas, adenosquamous carcinomas, islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas; patients with tumors that are largely intraductal papillary mucinous neoplasms (IPMN) with a minimal or minor component of invasive carcinoma are not eligible; patients with acinar carcinomas are not eligible; patients with IPMN's that contain some secondary (minor) foci of adenocarcinoma are also not eligible * Patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy * Patients entering on the study after pancreaticoduodenectomy, who have not already started chemotherapy must not have had prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, patients must not have received adjuvant chemotherapy with agents other than gemcitabine, nab-paclitaxel, oxaliplatin, fluoropyrimidine, or irinotecan for the current pancreatic cancer; prior chemotherapy for a different cancer is allowable * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Previous history of invasive malignancy (except non-melanoma skin cancer) unless the patient has been disease free for at least 2 years prior to study entry (or first day of chemotherapy for patients having started chemotherapy prior to first step registration); patients with a previous history of carcinoma in situ are eligible * Severe, active co-morbidity, defined as follows per time points indicated below (or per time points indicated below prior to the first day of chemotherapy for patients having started chemotherapy prior to first step registration): * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the 3 months of study registration * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Pregnant or lactating women * Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic * If surgical margin status cannot be determined after consultation with the operating surgeon and the institutional pathologist, the patient will be ineligible
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive either gemcitabine hydrochloride or allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    intervention Names
    1. Procedure: Biospecimen Collection
    2. Drug: Chemotherapy
    3. Procedure: Computed Tomography
    4. Drug: Gemcitabine Hydrochloride
    5. Procedure: Magnetic Resonance Imaging
    6. Other: Quality-of-Life Assessment
    7. Procedure: X-Ray Imaging
    label
    Arm I (gemcitabine hydrochloride or combination chemotherapy)
    type
    ACTIVE_COMPARATOR
  2. description
    Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline. (closed to accrual 4/2/14)
    intervention Names
    1. Procedure: Biospecimen Collection
    2. Procedure: Computed Tomography
    3. Drug: Erlotinib Hydrochloride
    4. Drug: Gemcitabine Hydrochloride
    5. Procedure: Magnetic Resonance Imaging
    6. Other: Quality-of-Life Assessment
    7. Procedure: X-Ray Imaging
    label
    Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)
    type
    EXPERIMENTAL
  3. description
    Patients receive the same treatment as in arm I for 1 month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    intervention Names
    1. Procedure: Biospecimen Collection
    2. Drug: Chemotherapy
    3. Procedure: Computed Tomography
    4. Drug: Gemcitabine Hydrochloride
    5. Procedure: Magnetic Resonance Imaging
    6. Other: Quality-of-Life Assessment
    7. Procedure: X-Ray Imaging
    label
    Arm III (chemotherapy)
    type
    EXPERIMENTAL
  4. description
    Patients receive the same treatment as in arm I for 1 month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    intervention Names
    1. Radiation: 3-Dimensional Conformal Radiation Therapy
    2. Procedure: Biospecimen Collection
    3. Drug: Capecitabine
    4. Drug: Chemotherapy
    5. Procedure: Computed Tomography
    6. Drug: Fluorouracil
    7. Drug: Gemcitabine Hydrochloride
    8. Radiation: Intensity-Modulated Radiation Therapy
    9. Procedure: Magnetic Resonance Imaging
    10. Other: Quality-of-Life Assessment
    11. Procedure: X-Ray Imaging
    label
    Arm IV (chemotherapy, chemoradiotherapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm IV (chemotherapy, chemoradiotherapy)
    description
    Undergo 3-dimensional conformal radiation therapy
    name
    3-Dimensional Conformal Radiation Therapy
    other Names
    1. 3-dimensional radiation therapy
    2. 3D Conformal
    3. 3D CONFORMAL RADIATION THERAPY
    4. 3D CRT
    5. 3D radiotherapy
    6. 3D-CRT
    7. Conformal Therapy
    8. Radiation Conformal Therapy
    9. Radiation, 3D Conformal
    10. Three dimensional external beam radiation therapy (procedure)
    type
    RADIATION
  2. arm Group Labels
    1. Arm I (gemcitabine hydrochloride or combination chemotherapy)
    2. Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)
    3. Arm III (chemotherapy)
    4. Arm IV (chemotherapy, chemoradiotherapy)
    description
    Undergo blood and tissue sample collection
    name
    Biospecimen Collection
    other Names
    1. Biological Sample Collection
    2. Biospecimen Collected
    3. Specimen Collection
    type
    PROCEDURE
  3. arm Group Labels
    1. Arm IV (chemotherapy, chemoradiotherapy)
    description
    Given PO
    name
    Capecitabine
    other Names
    1. Ro 09-1978/000
    2. Xeloda
    type
    DRUG
  4. arm Group Labels
    1. Arm I (gemcitabine hydrochloride or combination chemotherapy)
    2. Arm III (chemotherapy)
    3. Arm IV (chemotherapy, chemoradiotherapy)
    description
    Given combination chemotherapy
    name
    Chemotherapy
    other Names
    1. Chemo
    2. Chemotherapy (NOS)
    3. Chemotherapy, Cancer, General
    type
    DRUG
  5. arm Group Labels
    1. Arm I (gemcitabine hydrochloride or combination chemotherapy)
    2. Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)
    3. Arm III (chemotherapy)
    4. Arm IV (chemotherapy, chemoradiotherapy)
    description
    Undergo CT
    name
    Computed Tomography
    other Names
    1. CAT
    2. CAT Scan
    3. Computed Axial Tomography
    4. Computerized Axial Tomography
    5. Computerized axial tomography (procedure)
    6. Computerized Tomography
    7. Computerized Tomography (CT) scan
    8. CT
    9. CT Scan
    10. Diagnostic CAT Scan
    11. Diagnostic CAT Scan Service Type
    12. tomography
    type
    PROCEDURE
  6. arm Group Labels
    1. Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)
    description
    Given PO
    name
    Erlotinib Hydrochloride
    other Names
    1. CP 358
    2. CP-358
    3. Cp-358,774
    4. CP358
    5. OSI 774
    6. OSI-774
    7. OSI774
    8. Tarceva
    type
    DRUG
  7. arm Group Labels
    1. Arm IV (chemotherapy, chemoradiotherapy)
    description
    Given IV
    name
    Fluorouracil
    other Names
    1. 5 Fluorouracil
    2. 5 Fluorouracilum
    3. 5 FU
    4. 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
    5. 5-Fluorouracil
    6. 5-Fluracil
    7. 5-Fu
    8. 5FU
    9. AccuSite
    10. Carac
    11. Fluoro Uracil
    12. Fluouracil
    type
    DRUG
  8. arm Group Labels
    1. Arm I (gemcitabine hydrochloride or combination chemotherapy)
    2. Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)
    3. Arm III (chemotherapy)
    4. Arm IV (chemotherapy, chemoradiotherapy)
    description
    Given IV
    name
    Gemcitabine Hydrochloride
    other Names
    1. dFdCyd
    2. Difluorodeoxycytidine Hydrochloride
    3. Gemcitabine HCI
    4. Gemzar
    5. LY 188011
    6. LY-188011
    7. LY188011
    type
    DRUG
  9. arm Group Labels
    1. Arm IV (chemotherapy, chemoradiotherapy)
    description
    Undergo intensity-modulated radiation therapy
    name
    Intensity-Modulated Radiation Therapy
    other Names
    1. IMRT
    2. Intensity modulated radiation therapy (procedure)
    3. Intensity Modulated RT
    4. Intensity-Modulated Radiotherapy
    5. Radiation, Intensity-Modulated Radiotherapy
    type
    RADIATION
  10. arm Group Labels
    1. Arm I (gemcitabine hydrochloride or combination chemotherapy)
    2. Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)
    3. Arm III (chemotherapy)
    4. Arm IV (chemotherapy, chemoradiotherapy)
    description
    Undergo MRI
    name
    Magnetic Resonance Imaging
    other Names
    1. Magnetic Resonance
    2. Magnetic Resonance Imaging (MRI)
    3. Magnetic resonance imaging (procedure)
    4. Magnetic Resonance Imaging Scan
    5. Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    6. MR
    7. MR Imaging
    8. MRI
    9. MRI Scan
    10. MRIs
    11. NMR Imaging
    12. NMRI
    type
    PROCEDURE
  11. arm Group Labels
    1. Arm I (gemcitabine hydrochloride or combination chemotherapy)
    2. Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)
    3. Arm III (chemotherapy)
    4. Arm IV (chemotherapy, chemoradiotherapy)
    description
    Ancillary studies
    name
    Quality-of-Life Assessment
    other Names
    1. Quality of Life Assessment
    type
    OTHER
  12. arm Group Labels
    1. Arm I (gemcitabine hydrochloride or combination chemotherapy)
    2. Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)
    3. Arm III (chemotherapy)
    4. Arm IV (chemotherapy, chemoradiotherapy)
    description
    Undergo x-ray imaging
    name
    X-Ray Imaging
    other Names
    1. Conventional X-Ray
    2. Diagnostic Radiology
    3. Medical Imaging, X-Ray
    4. Plain film radiographs
    5. Radiographic Imaging
    6. Radiographic imaging procedure (procedure)
    7. Radiography
    8. RG
    9. Static X-Ray
    10. X-Ray
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
546
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Baseline PROMIS Fatigue scores will be analyzed to determine if there is a cut point (adjusting for multiple comparisons) that correlates with overall survival using the log-rank statistic. The analysis population is all enrolled eligible participants who consented to the quality of life study component and who have baseline PROMIS data.
    measure
    Determination of National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue and Overall Survival
    time Frame
    From enrollment to death or last follow-up.
  2. measure
    Frequency of Objective Criteria of Resectability as Measured by Preoperative Imaging
    time Frame
    Baseline
  3. description
    NIH-required analysis. Overall survival (OS) is estimated by the Kaplan-Meier method. Survival time is measured from step 2 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all patients have five years potential follow-up from step 2 randomization.
    measure
    Overall Survival (Percentage of Participants Alive) [Phase III] by Sex
    time Frame
    From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to the date of death or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.
  4. description
    NIH-required analysis. Overall survival (OS) is estimated by the Kaplan-Meier method. Survival time is measured from step 2 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all patients have five years potential follow-up from step 2 randomization.
    measure
    Overall Survival (Percentage of Participants Alive) [Phase III] by Ethnicity
    time Frame
    From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to the date of death or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.
  5. description
    NIH-required analysis. Overall survival (OS) is estimated by the Kaplan-Meier method. Survival time is measured from step 2 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all patients have five years potential follow-up from step 2 randomization.
    measure
    Overall Survival (Percentage of Participants Alive) [Phase III] by Race
    time Frame
    From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to the date of death or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.
primary Outcomes
  1. description
    Overall survival is estimated by the Kaplan-Meier method. Survival time is measured from step 1 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur after 200 deaths were reported.
    measure
    Overall Survival (Percentage of Participants Alive) [Phase II]
    time Frame
    From step 1 randomization (gemcitabine vs. gemcitabine/erlotinib) to death or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years.
  2. description
    Overall survival (OS) is estimated by the Kaplan-Meier method. Survival time is measured from step 2 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all patients have five years potential follow-up from step 2 randomization.
    measure
    Overall Survival (Percentage of Participants Alive) [Phase III]
    time Frame
    From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to the date of death or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.
secondary Outcomes
  1. description
    Disease-free survival is estimated by the Kaplan-Meier method. Disease-free survival time is measured from step 1 randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to any cause, or last known follow-up (censored). Analysis was to occur after 200 deaths were reported.
    measure
    Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase II]
    time Frame
    From step1 randomization (gemcitabine vs. gemcitabine/erlotinib) to disease event, death, or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years. Five-year rates are reported here.
  2. description
    Disease-free survival is estimated by the Kaplan-Meier method. Disease-free survival time is measured from step 2 randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to any cause, or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all participants have five years potential follow-up from second step randomization.
    measure
    Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase III]
    time Frame
    From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to disease event, death, or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.
  3. description
    Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 which grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
    measure
    Number of Participants by Highest Grade Adverse Event Reported (Phase II)
    time Frame
    From step 1 randomization (gemcitabine vs. gemcitabine/erlotinib) to death or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years.
  4. description
    Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 which grades adverse event severity from 1=mild to 5=death.
    measure
    Number of Participants by Highest Grade Adverse Event Reported (Phase III)
    time Frame
    From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to death or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.
  5. description
    Overall survival is estimated by the Kaplan-Meier method. Survival time is measured from enrollment (step 1) to date of death from any cause or last known follow-up (censored). Baseline fatigue is measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACT-F) questionnaire which has a range of 0 to 52 with a higher score indicating less fatigue. Combining treatment arms, patients with low fatigue at baseline (FACIT-F score \> 30) will be compared to patients with high fatigue at baseline (FACIT-F scores ≤ 30).
    measure
    Overall Survival (Percentage of Participants Alive) by Baseline Fatigue Group
    time Frame
    From enrollment (step 1) to death or last follow-up. Maximum follow-up at time of the phase III analysis was 13.2 years, measured from enrollment. Two- and five-year rates are reported here.
Full study description
brief Summary
This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer.
detailed Description
PRIMARY OBJECTIVES: I. To determine whether the addition of erlotinib (erlotinib hydrochloride) to gemcitabine (gemcitabine hydrochloride) adjuvant chemotherapy shows a signal for improved survival as compared to gemcitabine alone following R0 or R1 resection of head of pancreas adenocarcinoma (including adenocarcinoma of the head, neck, and uncinate process). (Phase II-R) II. To determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine based chemotherapy or non-gemcitabine based chemotherapy such as modified fluorouracil-leucovorin-irinotecan-oxaliplatin regimen (FOLFIRINOX) further enhances survival for such patients who are without evidence of progressive disease after 5 months of adjuvant chemotherapy. (Phase III) SECONDARY OBJECTIVES: I. To evaluate disease-free survival of adjuvant chemotherapy followed by radiotherapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after 5 months of adjuvant chemotherapy. II. To evaluate disease-free survival of standard adjuvant gemcitabine chemotherapy with and without erlotinib for patients with resected head of pancreas adenocarcinoma. III. To evaluate adverse events with and without erlotinib for patients with resected head of pancreas adenocarcinoma. IV. To evaluate adverse events of adjuvant chemotherapy with or without radiation therapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after adjuvant chemotherapy. V. To evaluate preoperative cross-sectional imaging of the primary head of pancreas adenocarcinoma in order to determine the frequency with which objective criteria of resectability are present. VI. To determine if patients reporting low baseline fatigue, as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, predicts survival and to explore correlations between baseline fatigue, as measured by Patient-Reported Outcomes Measurement Information System (PROMIS), and survival. OUTLINE: Patients without disease progression after treatment in arm I or II are randomized to 1 of 2 additional treatment arms (arm III or IV). ARM I: Patients receive either gemcitabine hydrochloride or allowable combination chemotherapy per standard of care for 5 months. ARM II (closed to accrual 4/2/14): Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride orally (PO) once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. ARM III: Patients receive the same treatment as in arm I for 1 month. ARM IV: Patients receive the same treatment as in arm I for 1 month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO twice daily (BID) 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo computed tomography (CT), magnetic resonance imaging (MRI), and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline. After completion of study treatment, patients are followed up every 3-6 months for up to 4 years, then yearly.
Source references
references
  1. citation
    Abrams RA, Winter KA, Goodman KA, Regine WF, Safran HP, Guha CS, Kachnic LA, Gillin MT, Philip PA, Lowy AM, O'Reilly E, Van Laethem JL, Seaward SA, Wu AJ, Wu JJ, Aljumaily RM, DiPetrillo TA, Geva R, Anne PR, Liles DK, Ling DC, Conlin A, Moughan J, Crane CH. Adjuvant Chemotherapy +/- Chemoradiotherapy for Adenocarcinoma of the Pancreatic Head: Results of the Radiotherapy Random Assignment of NRG Oncology/RTOG 0848. J Clin Oncol. 2026 Aug 20;44(24):2316-2328. doi: 10.1200/JCO-25-02520. Epub 2026 Jun 9.
    pmid
    42456089
    type
    DERIVED
  2. citation
    Jethwa KR, Kim E, Berlin J, Anker CJ, Tchelebi L, Abood G, Hallemeier CL, Jabbour S, Kennedy T, Kumar R, Lee P, Sharma N, Small W Jr, Williams V, Russo S. Executive Summary of the American Radium Society Appropriate Use Criteria for Neoadjuvant Therapy for Nonmetastatic Pancreatic Adenocarcinoma: Systematic Review and Guidelines. Am J Clin Oncol. 2024 Apr 1;47(4):185-199. doi: 10.1097/COC.0000000000001076. Epub 2023 Dec 22.
    pmid
    38131628
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  3. citation
    Tchelebi LT, Winter KA, Abrams RA, Safran HP, Regine WF, McNulty S, Wu A, Du KL, Seaward SA, Bian SX, Aljumaily R, Shivnani A, Knoble JL, Crocenzi TS, DiPetrillo TA, Roof KS, Crane CH, Goodman KA. Analysis of Radiation Therapy Quality Assurance in NRG Oncology RTOG 0848. Int J Radiat Oncol Biol Phys. 2024 Jan 1;118(1):107-114. doi: 10.1016/j.ijrobp.2023.08.014. Epub 2023 Aug 19.
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  4. citation
    Conroy T, Lambert A, Ducreux M. Adjuvant and neoadjuvant approaches in pancreatic cancer. Curr Opin Oncol. 2023 Jul 1;35(4):326-333. doi: 10.1097/CCO.0000000000000962. Epub 2023 May 12.
    pmid
    37222189
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  5. citation
    Batukbhai B, Herman JM, Zahurak M, Laheru DA, Le DT, Wolfgang CL, Zheng L, De Jesus-Acosta A. Survival Outcomes of Adjuvant Chemotherapy Combined With Radiation Versus Chemotherapy Alone After Pancreatectomy for Distal Pancreatic Adenocarcinoma: A Single-Institution Experience. Pancreas. 2021 Jan 1;50(1):64-70. doi: 10.1097/MPA.0000000000001724.
    pmid
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    Preserved source evidence · Not medical advice