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Completed

NCT Number: NCT00608205

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

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.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cisplatin

Drug

Given IV

Other names: CDDP

Fluorouracil

Drug

Given IV

radiation therapy

Radiation

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks

Other names: radiation

Primary outcomes

  1. Relapse Free Survival

    Time frame: 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 outcomes

  1. Patterns of Failure

    Time frame: 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.

  2. Overall Survival

    Time frame: 2 yrs from start of study

    Number of patients still alive from 2 years from start of study

  3. Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor

    Time frame: 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.

  4. Number of Patients With a Pathological(Final)Complete Response

    Time frame: 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.

  5. Disease Recurrence

    Time frame: 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.

  6. Number of Patients That Required a Feeding Tube

    Time frame: 12 weeks (after treatment)

  7. Number of Patients That Required a Feeding Tube

    Time frame: 8 months after start of treatment

  8. Number of Patients That Required a Feeding Tube

    Time frame: 12 months after start of treatment

  9. Number of Patients That Required a Feeding Tube

    Time frame: 24 months after start of treatment

  10. Nausea Level

    Time frame: 12 weeks (after treatment)

    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.

  11. Nausea Level

    Time frame: 8 months from start of treatment

    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.

  12. Nausea Level

    Time frame: 12 months from start of treatment

    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.

  13. Nausea Level

    Time frame: 24 months from start of treatment

    Quality of life questionnaire asking "I have nausea".

  14. Dry Mouth

    Time frame: 12 weeks (after 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.

  15. Dry Mouth

    Time frame: 8 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.

  16. Dry Mouth

    Time frame: 12 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.

  17. Dry Mouth

    Time frame: 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.

  18. Pain

    Time frame: 12 weeks (after 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.

  19. Pain

    Time frame: 8 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.

  20. Pain

    Time frame: 12 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.

  21. Pain

    Time frame: 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.

  22. Quality of Life

    Time frame: 12 weeks (after 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.

  23. Quality of Life

    Time frame: 8 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.

  24. Quality of Life

    Time frame: 12 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.

  25. Quality of Life

    Time frame: 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.

  26. Eating

    Time frame: 12 weeks (after 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.

  27. Eating

    Time frame: 8 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.

  28. Eating

    Time frame: 12 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.

  29. Eating

    Time frame: 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.

  30. Swallowing

    Time frame: 12 weeks (after 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.

  31. Swallowing

    Time frame: 8 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.

  32. Swallowing

    Time frame: 12 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.

  33. Swallowing

    Time frame: 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.

  34. Alcohol Consumption

    Time frame: 12 weeks (after 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.

  35. Alcohol Consumption

    Time frame: 8 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.

  36. Alcohol Consumption

    Time frame: 12 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.

  37. Alcohol Consumption

    Time frame: 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.

  38. Solid Foods

    Time frame: 12 weeks (after 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.

  39. Solid Foods

    Time frame: 8 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.

  40. Solid Foods

    Time frame: 12 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.

  41. Solid Foods

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

A Phase III Randomized Trial Comparing Single Agent Cisplatin With the Combination of 5-Fluorouracil and Cisplatin, Concurrent With Radiation Therapy in Stage III and IV Squamous Cell Head and Neck Cancer

Important dates

Study start
2008
Primary completion
2012
Study completion
2016
First posted
Feb 6, 2008
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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