TriangleNCT00608205 · REGISTRY CONDITION SEARCH
Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2020-08-06
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without fluorouracil in treating patients with head and neck cancer. PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to compare how well they work with or without fluorouracil in treating patients with stage III or stage IV head and neck 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.
Participant flow
Baseline characteristics
Relapse Free Survival
Patterns of Failure
Overall Survival
Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor
Number of Patients With a Pathological(Final)Complete Response
Disease Recurrence
Number of Patients That Required a Feeding Tube
Number of Patients That Required a Feeding Tube
Number of Patients That Required a Feeding Tube
Number of Patients That Required a Feeding Tube
Nausea Level
Nausea Level
Nausea Level
Nausea Level
Dry Mouth
Dry Mouth
Dry Mouth
Dry Mouth
Pain
Pain
Pain
Pain
Quality of Life
Quality of Life
Quality of Life
Quality of Life
Eating
Eating
Eating
Eating
Swallowing
Swallowing
Swallowing
Swallowing
Alcohol Consumption
Alcohol Consumption
Alcohol Consumption
Alcohol Consumption
Solid Foods
Solid Foods
Solid Foods
Solid Foods
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx * No histologic diagnosis other than squamous cell carcinoma * A primary site must be identified * Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease * No evidence of nodal disease below the clavicles or distant hematogenous metastases (M0) * No stage IVC disease (stage IVB disease allowed) * Deemed appropriate for definitive non-operative management with curative intent * Resectable disease is not required * No primary cancer of the nasopharynx, paranasal sinus, or salivary gland PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC \> 3,500/mm³ * Platelet count \> 100,000/mm³ * Serum creatinine \< 2.0 mg/dL * Alkaline phosphatase \< 2 times normal * AST \< 2 times normal * Bilirubin ≤ 2.0 mg/dL * Serum calcium normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No unstable or uncontrolled angina * No clinically apparent jaundice * No active infection * No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ), unless the patient has been continuously disease-free for at least 5 years * Not a poor compliance risk * Able to withstand the rigors of intensive treatment * Available for and compliant with adequate long-term follow-up PRIOR CONCURRENT THERAPY: * No prior definitive surgery or radiotherapy for this malignancy * No prior chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for any disease Patients who have had previous definitive surgery, or radiation therapy for this malignancy, and patients who have had any previous chemotherapy, immunotherapy, or EGF receptor inhibition for any disease are ineligible. Exclusion Criteria Patients with primary cancers of the nasopharynx, paranasal sinus or salivary gland are ineligible. Patients with unstable or uncontrolled angina, clinically apparent jaundice, or active infection are ineligible. Patients with a history of any other malignancy (except squamous or basal cell skin cancer or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously disease-free for at least 5 years. Patients with any histologic diagnosis other than squamous cell carcinoma are ineligible. Patients who might be a poor-compliance risk are ineligible. Pregnant or breastfeeding women are ineligible. Women/men of reproductive potential must be willing to practice acceptable methods of birth control to prevent pregnancy.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
- intervention Names
- Drug: cisplatin
- Radiation: radiation therapy
- label
- Arm A: Radiation with concurrent Cisplatin
- type
- ACTIVE_COMPARATOR
- description
- Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
- intervention Names
- Drug: cisplatin
- Drug: fluorouracil
- Radiation: radiation therapy
- label
- Arm B: Radiation with concurrent 5-FU and Cisplatin
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Arm A: Radiation with concurrent Cisplatin
- Arm B: Radiation with concurrent 5-FU and Cisplatin
- description
- Given IV
- name
- cisplatin
- other Names
- CDDP
- type
- DRUG
- arm Group Labels
- Arm B: Radiation with concurrent 5-FU and Cisplatin
- description
- Given IV
- name
- fluorouracil
- type
- DRUG
- arm Group Labels
- Arm A: Radiation with concurrent Cisplatin
- Arm B: Radiation with concurrent 5-FU and Cisplatin
- description
- Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks
- name
- radiation therapy
- other Names
- radiation
- type
- RADIATION
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 69
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..
- measure
- Relapse Free Survival
- time Frame
- at 2 yrs from start of study
- secondary Outcomes
- description
- Patients with any new evidence of cancer after achieving a complete response are considered to have recurrent disease. Biopsy verification will be obtained if at all possible and salvage surgery is recommended if possible. Disease recurrence will be characterized as either local, regional(nodal) or distant recurrence. Patients may have more than one kind of recurrence.
- measure
- Patterns of Failure
- time Frame
- 2 years from start of study
- description
- Number of patients still alive from 2 years from start of study
- measure
- Overall Survival
- time Frame
- 2 yrs from start of study
- description
- Twelve weeks after completing chemoradiotherapy, a formal evaluation for response will be made, to include a careful evaluation by the head and neck surgeon, medical and radiation oncologists, and, as appropriate, a radiologic and an endoscopic examination. Patients will be considered to have achieved either a clinical complete response (i.e. complete disappearance of all clinically and radiologically detectable tumor) or to have clinical persistent disease.
- measure
- Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor
- time Frame
- at 12 weeks after completing chemoradiotherapy
- description
- A Pathological, or final response will be assigned to subjects after any salvage surgery is performed for clinical persistent disease, and after planned neck dissection in those achieving a clinical complete response. If no surgery is performed after chemoradiotherapy, the clinical and pathological (final) response will be the same. Patient will be coded as having either a pathologic complete response, or as having pathologic persistent disease. A pathologic complete response will be defined as the total disappearance of all clinically and radiologically detectable tumor.
- measure
- Number of Patients With a Pathological(Final)Complete Response
- time Frame
- at 12 weeks after completing chemoradiotherapy and surgery
- description
- Number of patients with any new evidence of cancer after achieving a complete response (at 12 weeks after completing chemoradiotherapy) are considered to have recurrent disease.
- measure
- Disease Recurrence
- time Frame
- 2 years after start of study
- measure
- Number of Patients That Required a Feeding Tube
- time Frame
- 12 weeks (after treatment)
- measure
- Number of Patients That Required a Feeding Tube
- time Frame
- 8 months after start of treatment
- measure
- Number of Patients That Required a Feeding Tube
- time Frame
- 12 months after start of treatment
- measure
- Number of Patients That Required a Feeding Tube
- time Frame
- 24 months after start of treatment
- description
- Quality of life questionnaire asking "I have nausea". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). N (number of patients analyzed) is based on number of patients who completed the question.
- measure
- Nausea Level
- time Frame
- 12 weeks (after treatment)
- description
- Quality of life questionnaire asking "I have nausea". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
- measure
- Nausea Level
- time Frame
- 8 months from start of treatment
- description
- Quality of life questionnaire asking "I have nausea". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
- measure
- Nausea Level
- time Frame
- 12 months from start of treatment
Full study description
- brief Summary
- RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without fluorouracil in treating patients with head and neck cancer. PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to compare how well they work with or without fluorouracil in treating patients with stage III or stage IV head and neck cancer.
- detailed Description
- OBJECTIVES: * To compare the relapse-free survival of patients treated with radiotherapy and cisplatin with vs without fluorouracil. * To compare the overall survival, local control without surgery, and patterns of failure in patients treated with these regimens. * To compare the acute and long-term toxicity of these regimens in these patients. * To compare the quality of life of patients treated with these regimens. * To prospectively collect biopsy material, mucosal scrapings, and serum in an effort to generate hypotheses for future correlative studies. OUTLINE: This is a multicenter study. Patients are stratified according to radiotherapy schedule (once daily vs twice daily) and radiotherapy planning (2D vs 3D vs intensity-modulated radiotherapy). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. * Arm II: Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy. Patients with biopsy-verified residual disease at the primary site or local recurrence after achieving a complete response to chemoradiotherapy may undergo salvage surgery 12 weeks after the completion of chemoradiotherapy. Patients complete questionnaires periodically to assess late toxicity and quality of life. After completion of study treatment, patients are followed periodically.
Source references
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice