NCT00113399 · REGISTRY CONDITION SEARCH

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery

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: TERMINATED
Registry last update: 2013-07-02

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.

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

Overall Survival

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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: DISEASE CHARACTERISTICS: * Histologically\* or cytologically\* confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, or larynx, including any of the following histologic variants: * Spindle cell carcinoma * Poorly differentiated keratin-positive carcinoma * Lymphoepithelioma NOTE: \*Biopsy or primary tumor and/or fine needle aspiration of the metastatic lymph node required * Original or second primary tumor * Recurrent neck metastases with unknown primary allowed * Locally recurrent disease * Measurable disease * Unresectable disease * Attempted surgical resection allowed provided surgery was performed ≥ 3 months ago, wound is completely healed, and there is no sign of carotid exposure * Must have had prior radiotherapy for SCC of the head and neck with \> 75% of the present tumor volume in areas irradiated at doses ≥ 45 Gy but ≤ 75 Gy * Able to successfully re-irradiate the area of the gross tumor volume without exceeding lifetime spinal cord dose of 54 Gy as determined by physical examination and CT scan and/or MRI performed within the past 8 weeks * First recurrence occurred \> 6 months after completion of radiotherapy * More than 1 recurrence allowed provided the above criteria for first recurrence has been met * No primary tumor of the nasopharynx or salivary gland * No distant metastases by history or physical examination, chest CT scan, and CT scan or MRI of the tumor site * Patients with equivocal pulmonary nodules are eligible provided the nodules are \< 1 cm, can be safely biopsied, or are negative by positron emission tomography imaging * No circumferential tumor involvement of the carotid sheath by imaging unless prophylactic carotid stent is placed PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,800/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed) Hepatic * AST or ALT \< 2 times upper limit of normal (ULN) * Bilirubin \< 1.5 mg/dL * No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects Renal * Creatinine clearance \> 50 mL/min * Calcium \< 11.5 mg/dL Cardiovascular * No New York Heart Association class III or IV heart disease * No other symptomatic or uncontrolled cardiac disease Pulmonary * No chronic obstructive pulmonary disease exacerbation * No other respiratory illness requiring hospitalization within the past 6 months or that would preclude study therapy Immunologic * No AIDS * No prior allergic reaction to E. coli-derived products * No acute bacterial or fungal infection requiring IV antibiotics Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 30 days after completion of study treatment * No other invasive malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the breast, oral cavity, or cervix * No pre-existing peripheral sensory neuropathy \> grade 2 * No other severe active co-morbidity PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 6 months since prior chemotherapy * No prior systemic chemotherapy for recurrent SCC of the head and neck * Prior neoadjuvant, adjuvant, and/or concurrent chemotherapy and radiotherapy for initial SCC of the head and neck allowed Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * See Chemotherapy * At least 6 months since prior radiotherapy Surgery * See Disease Characteristics Other * Prior cyclooxygenase-2 inhibitor or retinoids for chemoprevention allowed * At least 6 months since prior epidermal growth factor receptor (EGFR) inhibitors or other targeted agents * No prior EGFR inhibitors or other targeted agents for recurrent SCC of the head and neck * No concurrent cimetidine or allopurinol (for patients on arm II, regimen 1)
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Radiotherapy/paclitaxel/cisplatin/filgrastim
intervention Names
Biological: filgrastim
Drug: cisplatin
Drug: paclitaxel
Radiation: radiation therapy
label
Radiotherapy and chemotherapy
type
OTHER
description
Cisplatin/fluorouracil/paclitaxel/docetaxel
intervention Names
Drug: cisplatin
Drug: docetaxel
Drug: fluorouracil
Drug: paclitaxel
label
Chemotherapy
type
OTHER

interventions

arm Group Labels
Radiotherapy and chemotherapy
name
filgrastim
type
BIOLOGICAL
arm Group Labels
Chemotherapy
Radiotherapy and chemotherapy
name
cisplatin
type
DRUG
arm Group Labels
Chemotherapy
name
docetaxel
type
DRUG
arm Group Labels
Chemotherapy
name
fluorouracil
type
DRUG
arm Group Labels
Chemotherapy
Radiotherapy and chemotherapy
name
paclitaxel
type
DRUG
arm Group Labels
Radiotherapy and chemotherapy
name
radiation therapy
type
RADIATION

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 15
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Overall Survival
time Frame
Date of death or last follow-up

Full study description

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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice