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NCT02254278 · CITED IN SOURCE DOCUMENTS

Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer

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
2026-05-22

This randomized phase II trial studies the side effects and how well modestly reduced-dose intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating patients with oropharyngeal cancer that has spread to other places in the body (advanced). Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, 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. It is not yet known whether IMRT is more effective with or without cisplatin in treating patients with oropharyngeal 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

Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival)

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outcome · POSTED

Percentage of Participants With Local-regional Failure

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outcome · POSTED

Percentage of Participants With Distant Metastasis

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outcome · POSTED

Percentage of Participants Alive

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outcome · POSTED

Percentage of Participants With Grade 3+ Adverse Events

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outcome · POSTED

Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome)

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outcome · POSTED

Negative Predictive Value (NPV) of Post-treatment FDG-PET/CT Scan [Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT)] for Progression-free Survival and Local-regional Control at Two Years

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outcome · POSTED

Percentage of Participants Positive for Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) After Treatment (Detection Rate)

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outcome · POSTED

Change in Number of HPV DNA Fragments/mL (Copy Number) From Baseline to During Treatment (HPV DNA Rate Decline)

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outcome · POSTED

Correlation of Baseline Log HPV DNA Copy Number and Gross Tumor Volume (GTV)

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outcome · POSTED

Natural Logarithm (ln) of Baseline HPV DNA Copy Number [for Purpose of Correlation]

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outcome · POSTED

Gross Tumor Volume (GTV) [for Purpose of Correlation]

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outcome · POSTED

HPV DNA Status by 2-year Local-regional Failure Status

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outcome · POSTED

HPV DNA Status by 2-year Progression-free Survival Status

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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 Step 1: Registration: 1. Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage). 2. Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions. 3. Immunohistochemical staining for p16 must be performed on tissue, and this tissue must be submitted for central review. Fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue if formalin-fixed paraffin-embedded cell block material is available for p16 immunohistochemistry. FNA specimens prepared with adequate p16 testing in this manner are acceptable to submit for central review. If the p16 preparation is not adequate, additional specimens will be required to establish p16 status. Centers are encouraged to contact the pathology chairs for clarification. 4. Clinical stage T1-T2, N1-N2b or T3, N0-N2b (AJCC, 7th ed.) including no distant metastases based on the following diagnostic workup: * General history and physical examination within 56 days prior to registration; * Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 70 days prior to registration; * One of the following combinations of imaging is required within 56 days prior to registration: 1. A computed tomography (CT) scan of the neck (with contrast) and a chest CT scan (with or without contrast); 2. or an MRI of the neck (with contrast) and a chest CT scan (with or without contrast); 3. or a CT scan of neck (with contrast) and a PET/CT of neck and chest (with or without contrast); 4. or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast). Note: A CT scan of neck and/or a PET/CT performed for the purposes of radiation planning may serve as both staging and planning tools. 5. Patients must provide their personal smoking history prior to registration. The lifetime cumulative history cannot exceed 10 pack-years. The following formula is used to calculate the pack-years during the periods of smoking in the patient's life; the cumulative total of the number of pack-years during each period of active smoking is the lifetime cumulative history. Number of pack-years = \[Frequency of smoking (number of cigarettes per day) × duration of cigarette smoking (years)\] / 20 Note: Twenty cigarettes is considered equivalent to one pack. The effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined. While there are reportedly increased risks of head and neck cancer associated with sustained heavy cigar and pipe use (Wyss 2013), such sustained use of non-cigarette products is unusual and does not appear to convey added risk with synchronous cigarette smoking. Cigar and pipe tobacco consumption is therefore not included in calculating the lifetime pack-years. Marijuana consumption is likewise not considered in this calculation. There is no clear scientific evidence regarding the role of chewing tobacco-containing products in this disease, although this is possibly more concerning given the proximity of the oral cavity and oropharynx. In any case, investigators are discouraged from enrolling patients with a history of very sustained use (such as several years or more) of non-cigarette tobacco products alone. 6. Zubrod Performance Status of 0-1 within 56 days prior to registration; 7. Age ≥ 18; 8. The trial is open to both genders; 9. Adequate hematologic function within 14 days prior to registration, defined as follows: * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; * Platelets ≥ 100,000 cells/mm3; * Hemoglobin (Hgb) ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable. 10. Adequate renal function within 14 days prior to registration, defined as follows: • Serum creatinine (Cr) \< 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula: * CC male = \[(140 - age) x (wt in kg)\] / \[(Serum Cr mg/dl) x (72)\] * CC female = 0.85 x (CC male) 11. Adequate hepatic function within 14 days prior to registration defined as follows: * Bilirubin \< 2 mg/dl; * Aspartate transaminase (AST) or alanine transaminase (ALT) \< 3 x the upper limit of normal. 12. Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential; 13. Patients who are HIV positive but have no prior Acquired Immune Deficiency Syndrome (AIDS) -defining illness and have CD4 cells of at least 350/mm3 are eligible. HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions. Patients must not be sero-positive for Hepatitis B (Hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C (anti-Hepatitis C antibody positive). However, patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B). 14. The patient must provide study-specific informed consent prior to study entry, including consent for mandatory submission of tissue for required, central p16 review. 15. Patients who speak English (or read one of the languages for which a translation is available (see Section 10.2) must consent to complete the mandatory dysphagia-related patient reported instrument (MDADI). If the patient cannot understand spoken English and reads only languages not available in the MDADI translations, the patient can still participate in the trial, as this has been factored into the trial statistics. For all other patients, the MDADI is mandatory as it is included in the primary endpoint to be studied. Step 2: Randomization: 16. p16 positive by immunohistochemistry (defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells), confirmed by central pathology review; (see Section 10.1 for details). Exclusion Criteria Step 1: Registration: 1. Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas; 2. Carcinoma of the neck of unknown primary site origin (even if p16 positive); 3. Radiographically matted nodes, defined as 3 abutting nodes with loss of the intervening fat plane; 4. Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle; 5. Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles; 6. Gross total excision of both primary and nodal disease with curative intent; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed. 7. Patients with simultaneous primary cancers or separate bilateral primary tumor sites are excluded with the exception of patients with bilateral tonsil cancers; 8. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible); 9. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; 10. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; 11. Severe, active co-morbidity defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; * Transmural myocardial infarction within the last 6 months; * 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 within 30 days of registration; * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those requested in Section 3.2.10. * Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition with immune compromise greater than that noted in Inclusion Criterion 13; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients. 12. Pregnancy; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. 13. Prior allergic reaction to cisplatin.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    IMRT 6 weeks with concurrent cisplatin
    intervention Names
    1. Drug: Cisplatin
    2. Radiation: IMRT 6 weeks
    label
    IMRT 6 weeks + cisplatin
    type
    EXPERIMENTAL
  2. description
    IMRT 5 weeks
    intervention Names
    1. Radiation: IMRT 5 weeks
    label
    IMRT 5 weeks
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. IMRT 6 weeks + cisplatin
    description
    40 mg/m2 IV (intravenously) weekly for 6 weeks
    name
    Cisplatin
    type
    DRUG
  2. arm Group Labels
    1. IMRT 6 weeks + cisplatin
    description
    Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    name
    IMRT 6 weeks
    other Names
    1. Intensity-Modulated Radiotherapy
    type
    RADIATION
  3. arm Group Labels
    1. IMRT 5 weeks
    description
    Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy
    name
    IMRT 5 weeks
    other Names
    1. Intensity-Modulated Radiotherapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
316
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Progression is defined as local, regional, or distant disease progression or death due to any cause. Percentage is estimated using the binomial distribution.
    measure
    Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival)
    time Frame
    From randomization to 2 years
secondary Outcomes
  1. description
    Local-regional failure is defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression. Distant metastasis and death due to other causes are considered competing risks. Local-regional failure time is defined as time from randomization to the date of first progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.
    measure
    Percentage of Participants With Local-regional Failure
    time Frame
    From randomization to 2 years
  2. description
    Distant metastasis is defined as distant progression. Local-regional failure and death due to any cause are considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method.
    measure
    Percentage of Participants With Distant Metastasis
    time Frame
    From randomization to 2 years
  3. description
    Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.
    measure
    Percentage of Participants Alive
    time Frame
    from randomization to 2 years
  4. description
    Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.
    measure
    Percentage of Participants With Grade 3+ Adverse Events
    time Frame
    End of radiation therapy (RT) (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2), then 1 month, 6 months, 1 year, and two years after end of RT
  5. description
    The MDADI is a 20-item tool with each item scored as Strongly agree; Agree; No opinion; Disagree; or Strongly disagree. There is 1 global item (G1), 6 emotional subscale items (E2-E7), 5 functional subscale items (F1-F5), and 8 physical subscale items (P1-P8). For all items except E7 and F2, Strongly agree corresponds to a score of 1, Agree 2, No opinion 3, Disagree 4, and Strongly disagree 5. For E7 and F2, the scores are reversed; these 2 items are rescored to match the others before calculating summary scores. The composite (total) score is the mean of the 19 items (other than G1) X 20. Composite scores range from 20 to 100 with higher scores indicating less dysphagia.
    measure
    Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome)
    time Frame
    One year post-RT. Radiation therapy (RT) ends at approximately 6 weeks for Arm 1 and 5 weeks for Arm 2
  6. description
    NPV is the percentage of participants alive and failure-free at 2 years among those with a negative post-treatment scan, as evaluated by central review. Negative scan determined as follows: primary site, right neck, left neck evaluated using a 5-point ordinal scale: 1-Definite complete metabolic response (CMR), 2-Likely CMR, 3-Likely inflammatory, 4-Likely residual metabolic disease (RMD), and 5-Definite RMD. 'Negative'= 1 or 2, 'Indeterminate'=3, 'Positive' = 4 or 5. 'Negative' for all three evaluation sites = overall score of 'Negative.' Progression (failure) is defined as local, regional, or distant disease progression (PR) or any death. Local-regional progression (failure) is defined as local or regional PR, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks post RT, death due to study cancer or unknown causes without documented PR. The protocol specified that both arms would be combined for analysis.
    measure
    Negative Predictive Value (NPV) of Post-treatment FDG-PET/CT Scan [Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT)] for Progression-free Survival and Local-regional Control at Two Years
    time Frame
    3 months (scan) and two years after the end of RT (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2)
  7. description
    Positive HPV DNA status is defined as 5 or more HPV DNA fragments per mL of blood plasma, assessed by tumor-tissue modified viral (TTMV) testing.
    measure
    Percentage of Participants Positive for Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) After Treatment (Detection Rate)
    time Frame
    Between 2 weeks to 1 month after treatment completion (approximately 6 weeks).
  8. description
    Calculated as treatment value - baseline value. HPV DNA was assessed by tumor-tissue modified viral (TTMV) testing.
    measure
    Change in Number of HPV DNA Fragments/mL (Copy Number) From Baseline to During Treatment (HPV DNA Rate Decline)
    time Frame
    Baseline and during treatment (obtained after 20 Gy of radiotherapy and before 28 Gy, approximately between day 10 and 14)
  9. description
    HPV DNA copy number is the number of HPV DNA fragments per mL of blood plasma, assessed by tumor-tissue modified viral (TTMV) testing. The natural logarithm of HPV DNA copy is used to determine correlation. GTV is the volume of the tumor determined by imaging used for treatment planning. The summary data of these two measures are reported separately in corresponding outcome measures. Correlation is measured by the Pearson correlation coefficient and ranges from -1 to +1, where ±1 indicates the strongest possible (negative or positive) correlation and 0 indicates no correlation. The study protocol indicates that participants are analyzed as a single group, treatment arms combined.
    measure
    Correlation of Baseline Log HPV DNA Copy Number and Gross Tumor Volume (GTV)
    time Frame
    Baseline
  10. description
    HPV DNA copy number is the number of HPV DNA fragments per mL of blood plasma, assessed by tumor-tissue modified viral (TTMV) testing. The natural logarithm of HPV DNA copy is used to determine correlation with gross tumor volume. Note that a natural log, by definition, has no units. The study protocol indicates that participants are analyzed as a single group, treatment arms combined. Correlation of Baseline Log HPV DNA Copy Number and Gross Tumor Volume (GTV) are reported in another outcome measure.
    measure
    Natural Logarithm (ln) of Baseline HPV DNA Copy Number [for Purpose of Correlation]
    time Frame
    Baseline
  11. description
    GTV is the volume of the tumor determined by imaging used for radiation treatment planning. The study protocol indicates that participants are analyzed as a single group, treatment arms combined. Correlation of Baseline Log HPV DNA Copy Number and Gross Tumor Volume (GTV) are reported in another outcome measure.
    measure
    Gross Tumor Volume (GTV) [for Purpose of Correlation]
    time Frame
    Baseline
  12. description
    Local-regional failure is defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression. Positive HPV DNA status is defined as 5 or more HPV DNA fragments per mL of blood plasma, assessed by tumor-tissue modified viral (TTMV) testing.
    measure
    HPV DNA Status by 2-year Local-regional Failure Status
    time Frame
    From end of treatment (approximate 6 weeks) to 2 years
Full study description
brief Summary
This randomized phase II trial studies the side effects and how well modestly reduced-dose intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating patients with oropharyngeal cancer that has spread to other places in the body (advanced). Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, 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. It is not yet known whether IMRT is more effective with or without cisplatin in treating patients with oropharyngeal cancer.
detailed Description
PRIMARY OBJECTIVES: -To select the arm(s) achieving a 2-year progression-free survival rate of \>= 85% without unacceptable swallowing toxicity at 1 year. SECONDARY OBJECTIVES: * To determine patterns of failure (locoregional relapse versus distant) and survival -(overall and progression-free) at 6 months and 2 years. * To determine acute toxicity profiles at the end of radiation therapy and at 1 and 6 months. * To determine late toxicity profiles at 1 and 2 years. * To determine patient-reported swallowing outcomes at 6 months and 1 and 2 years. * To determine the predictive value of 12-14 week, post-treatment fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) for locoregional control and progression free survival (PFS) at 2 years. * To determine the predictive value of blood and tissue biomarkers for disease outcomes at 2 years. * To determine swallowing recovery per videofluoroscopy imaging at 2 years. After completion of study treatment, patients are followed at 1 and 3 months then every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Source references
references
  1. citation
    Yom SS, Torres-Saavedra P, Caudell JJ, Waldron JN, Gillison ML, Xia P, Truong MT, Kong C, Jordan R, Subramaniam RM, Yao M, Chung CH, Geiger JL, Chan JW, O'Sullivan B, Blakaj DM, Mell LK, Thorstad WL, Jones CU, Banerjee RN, Lominska C, Le QT. Reduced-Dose Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma (NRG Oncology HN002). J Clin Oncol. 2021 Mar 20;39(9):956-965. doi: 10.1200/JCO.20.03128. Epub 2021 Jan 28.
    pmid
    33507809
    type
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Source notices and limitations
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        opharyngeal cancer</h4> <p id="_720" tabindex="-1">Studies evaluating de-intensification using reduced-dose radiation therapy (<a href="/clinicaltrials/NCT02254278">NRG-HN002</a> [NCT02254278] and <a href="/clinicaltrials/NCT01898494">ECOG-3311</a> [NCT01898494]) are ongoing in patients with low-risk HPV-positive orophary
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        <p id="_720" tabindex="-1">Studies evaluating de-intensification using reduced-dose radiation therapy (<a href="/clinicaltrials/NCT02254278">NRG-HN002</a> [NCT02254278] and <a href="/clinicaltrials/NCT01898494">ECOG-3311</a> [NCT01898494]) are ongoing in patients with low-risk HPV-positive oropharyngeal cancer. Cetuximab, an
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      3. context exact
        iate- to high-risk head and neck cancer. </li><li> Treatment de-intensification using radiation dose de-escalation is being studied in <a href="/clinicaltrials/NCT02254278">NRG-HN002</a> (NCT02254278). </li><li> Treatment de-intensification using transoral surgery followed by radiation dose de-escalation is being studied in <a hr
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      4. context exact
        neck cancer. </li><li> Treatment de-intensification using radiation dose de-escalation is being studied in <a href="/clinicaltrials/NCT02254278">NRG-HN002</a> (NCT02254278). </li><li> Treatment de-intensification using transoral surgery followed by radiation dose de-escalation is being studied in <a href="/clinicaltrials/NCT01898
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      Oropharyngeal Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice