Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer

Phase 3

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: cisplatin; Radiation: radiation therapy; Drug: fluorouracil

• Registration Number: NCT00608205
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-30
• Study First Submitted QC: 2008-01-31
• Study First Posted: 2008-02-06
• Primary Completion: 2012-09
• Results First Submitted: 2013-07-11
• Results First Submitted QC: 2013-07-11
• Results First Posted: 2013-09-19
• Study Completion: 2016-08
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B: Radiation with concurrent 5-FU and Cisplatin	cisplatin	Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Arm A: Radiation with concurrent Cisplatin	radiation therapy	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 B: Radiation with concurrent 5-FU and Cisplatin	radiation therapy	Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Arm B: Radiation with concurrent 5-FU and Cisplatin	fluorouracil	Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Arm A: Radiation with concurrent Cisplatin	cisplatin	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.

Primary Outcome Measures

Name	Time	Method
Relapse Free Survival	at 2 yrs from start of study	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..

Secondary Outcome Measures

Name	Time	Method
Eating	24 months from start of treatment	Quality of life questionnaire asking "I am able to eat the foods i like".; 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.
Disease Recurrence	2 years after start of study	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.
Number of Patients That Required a Feeding Tube	24 months after start of treatment
Nausea Level	24 months from start of treatment	Quality of life questionnaire asking "I have nausea".
Swallowing	24 months after start of treatment	Quality of life questionnaire asking "I can swallow naturally and easily".; 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.
Pain	24 months from start of treatment	Quality of life questionnaire asking "I have pain in my mouth, throat or neck".; 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.
Quality of Life	24 months from start of treatment	Quality of life questionnaire asking "I am content with the quality of my life right now".; 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.
Alcohol Consumption	24 months after start of treatment	Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".; 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.
Overall Survival	2 yrs from start of study	Number of patients still alive from 2 years from start of study
Patterns of Failure	2 years from start of study	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.
Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor	at 12 weeks after completing chemoradiotherapy	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.
Solid Foods	24 months after start of treatment	Quality of life questionnaire asking "I can eat solid foods".; 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.
Number of Patients With a Pathological(Final)Complete Response	at 12 weeks after completing chemoradiotherapy and surgery	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.
Dry Mouth	24 months from start of treatment	Quality of life questionnaire asking "My mouth is dry".; 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.

Trial Locations

Locations (2)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States