Clinical trial NCT00113399
Conditions: Head and Neck Cancer
Keywords: recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the oropharynx recurrent metastatic squamous neck cancer with occult primary recurrent lymphoepithelioma of the oropharynx
Sponsor: Radiation Therapy Oncology Group
Start date: 2005-04-01; Completion date: 2009-02-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin and paclitaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) and giving them with radiation therapy may kill more tumor cells. It is not yet known whether giving radiation therapy together with combination chemotherapy is more effective than giving combination chemotherapy alone in treating head and neck cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating patients with recurrent head and neck cancer that cannot be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* Compare overall survival of patients with previously irradiated unresectable locally recurrent squamous cell carcinoma of the head and neck treated with radiotherapy, cisplatin, and paclitaxel vs cisplatin-based chemotherapy alone.

Secondary

* Compare progression-free survival of patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
* Compare quality of life, functional/performance status, and quality-adjusted survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo radiotherapy twice daily and receive paclitaxel IV over 1 hour and cisplatin IV over 30 minutes once daily on days 1-5, 15-19, 29-33, and 43-47. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 6-13, 20-27, 34-41, and 48-55.
* Arm II: Patients receive 1 of the following cisplatin-based\* regimens at the discretion of the treating physician:

  * Regimen 1: Patients receive cisplatin\* IV over 1-2 hours on day 1 and fluorouracil IV continuously over 96 hours on days 1-4.
  * Regimen 2: Patients receive cisplatin\* IV over 1-2 hours and paclitaxel IV over 3 hours on day 1.
  * Regimen 3: Patients receive cisplatin\* IV over 1-2 hours and docetaxel IV over 1 hour on day 1.

NOTE: \*Carboplatin may be substituted for cisplatin in patients with creatinine clearance \< 50 mL/min or in patients who experience grade 2 or 3 neurotoxicity.

For all regimens, treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond documentation of CR.

Quality of life is assessed at baseline and then at 3, 6, 12, 24, and 36 months.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study within 5½ years.

Arms: arm 1: Radiotherapy/paclitaxel/cisplatin/filgrastim arm 2: Cisplatin/fluorouracil/paclitaxel/docetaxel
Interventions: intervention 1: filgrastim intervention 2: cisplatin intervention 3: docetaxel intervention 4: fluorouracil intervention 5: paclitaxel intervention 6: radiation therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents: