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NCT00789958 · CITED IN SOURCE DOCUMENTS

S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct

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

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2018-04-09

RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine together with gemcitabine followed by capecitabine and radiation therapy works in treating patients with cholangiocarcinoma of the gallbladder or bile duct.

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

Stratum-specific (R0 and R1) 2-year Overall Survival

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outcome · POSTED

Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

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outcome · POSTED

2-year Overall Survival for All Patients

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outcome · POSTED

2-year Stratum-specific Disease-free Survival

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outcome · POSTED

2-year Disease-free Survival in All Patients

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outcome · POSTED

2-year Stratum-specific Local Relapse Rate

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outcome · POSTED

2-year Overall Local Relapse Rate

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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
DISEASE CHARACTERISTICS: * Histopathologically confirmed extrahepatic cholangiocarcinoma of the gallbladder or bile duct, meeting at least 1 of the following criteria: * Pathological T2-4 disease * Pathological N1 disease * Positive margins (any T or N ) * Must have undergone potentially curative radical resection with negative (R0) or microscopically positive (R1) margins within the past 56 days and recovered (R0 stratum closed as of 12-15-11) * No distant metastatic disease as indicated by a CT scan or MRI of the chest, abdomen, and pelvis within the past 42 days * Positive resected regional lymph nodes allowed * No ampullary cancer PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * ANC \> 1,500/μL * Platelet count \> 100,000/μL * Serum creatinine \< 1.5 mg/dL * Total bilirubin \< 1.5 times upper limit of normal (ULN) * SGOT or SGPT \< 2.5 times ULN * Not pregnant or nursing * Fertile patients must use effective contraception * Able to swallow enteral medications and no requirement for a feeding tube * No intractable nausea or vomiting * No gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, requirement for IV alimentation, prior surgical procedures affecting absorptions. or uncontrolled inflammatory GI disease (e.g., Crohn disease, ulcerative colitis) * No uncontrolled intercurrent illness including but not limited to any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Myocardial infarction or cerebrovascular accident within the past 3 months * Uncontrolled diarrhea * Psychiatric illness or social situations that would limit compliance with study requirements * No prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for 5 years PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy or radiotherapy for this disease * No prior upper abdominal radiotherapy
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Adjuvant Chemotherapy * Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle * Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle Chemoradiotherapy -Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions. intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
    intervention Names
    1. Drug: capecitabine
    2. Drug: gemcitabine hydrochloride
    3. Radiation: 3-dimensional conformal radiation therapy
    4. Radiation: intensity-modulated radiation therapy
    label
    Adjuvant Chemo+ Chemoradiotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Adjuvant Chemo+ Chemoradiotherapy
    description
    Adjuvant chemotherapy: 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle Chemoradiotherapy: 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT
    name
    capecitabine
    other Names
    1. Xeloda
    2. NSC-712807
    type
    DRUG
  2. arm Group Labels
    1. Adjuvant Chemo+ Chemoradiotherapy
    description
    1000 mg/m\^2, IV, Days 1 \& 8 of each cycle
    name
    gemcitabine hydrochloride
    other Names
    1. Gemzar
    2. NSC-619927
    type
    DRUG
  3. arm Group Labels
    1. Adjuvant Chemo+ Chemoradiotherapy
    description
    4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions.
    name
    3-dimensional conformal radiation therapy
    other Names
    1. 3D radiotherapy
    type
    RADIATION
  4. arm Group Labels
    1. Adjuvant Chemo+ Chemoradiotherapy
    description
    4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
    name
    intensity-modulated radiation therapy
    other Names
    1. IMRT
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
105
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
    measure
    Stratum-specific (R0 and R1) 2-year Overall Survival
    time Frame
    Up to 2 years from registration
secondary Outcomes
  1. description
    Only adverse events that are possibly, probably or definitely related to study drug are reported.
    measure
    Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
    time Frame
    Up to 5 years
  2. description
    Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
    measure
    2-year Overall Survival for All Patients
    time Frame
    Up to 2 years from registration
  3. description
    Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.
    measure
    2-year Stratum-specific Disease-free Survival
    time Frame
    Up to 2 years from registration
  4. description
    Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.
    measure
    2-year Disease-free Survival in All Patients
    time Frame
    Up to 2 years from registration
  5. description
    Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).
    measure
    2-year Stratum-specific Local Relapse Rate
    time Frame
    Up to 2 years from registration
  6. description
    Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).
    measure
    2-year Overall Local Relapse Rate
    time Frame
    Up to 2 years from registration
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine together with gemcitabine followed by capecitabine and radiation therapy works in treating patients with cholangiocarcinoma of the gallbladder or bile duct.
detailed Description
OBJECTIVES: * To estimate the stratum-specific (R0 and R1) and overall 2-year survival probabilities of patients with extrahepatic cholangiocarcinoma treated with adjuvant chemotherapy comprising capecitabine and gemcitabine hydrochloride, followed by capecitabine and radiotherapy. (R0 stratum closed as of 12-15-11) * To estimate the 2-year stratum-specific and overall disease-free survival and local disease-free survival of patients treated with this regimen. * To assess the frequency and severity of toxicity in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to margin of resection (negative \[R0\] vs microscopically positive \[R1\]). (R0 stratum closed as of 12-15-11) * Adjuvant chemotherapy: Patients receive oral capecitabine every 12 hours on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. * Chemoradiotherapy: Beginning in week 13, patients receive oral capecitabine every 12 hours on days 1-7. Patients also undergo concurrent three-dimensional or intensity-modulated radiotherapy on days 1-5. Treatment repeats weekly for 5-6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study therapy patients are followed periodically for up to 5 years.
Source references
references
  1. citation
    Ben-Josef E, Guthrie KA, El-Khoueiry AB, Corless CL, Zalupski MM, Lowy AM, Thomas CR Jr, Alberts SR, Dawson LA, Micetich KC, Thomas MB, Siegel AB, Blanke CD. SWOG S0809: A Phase II Intergroup Trial of Adjuvant Capecitabine and Gemcitabine Followed by Radiotherapy and Concurrent Capecitabine in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma. J Clin Oncol. 2015 Aug 20;33(24):2617-22. doi: 10.1200/JCO.2014.60.2219. Epub 2015 May 11.
    pmid
    25964250
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      1. context
        Updated: March 28, 2025
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        display
        March 28, 2025

    Preserved source evidence · Not medical advice