Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy following surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have undergone surgery for stage III or stage IV head and neck cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx

• Gross total resection completed or planned

• No less than gross total resection

• No disease requiring staging surgery

• Prior gross total resection completed with one or more of the following risk factors:

• Histologically proven multiple lymph node metastases

• At least 1 lymph node with extracapsular extension of tumor

• Positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection OR

• Gross total resection planned within 14 days of study enrollment with anticipated need for postoperative radiotherapy for one of the following:

• Multiple clinically/radiologically evident lymph nodes of at least 1.5 cm

• Single clinically/radiologically evident lymph node of at least 3 cm

• Histologically proven lymph node metastases

• No T3, N0 glottic cancer

• No nasopharyngeal or paranasal sinus carcinoma

• No distant metastases

PATIENT CHARACTERISTICS:

Age:

• 21 and over

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• White blood cell (WBC) at least 3,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) no greater than 1.5 times ULN

Renal:

• Creatinine no greater than 1.5 ULN

Cardiovascular:

• No unstable angina

• No myocardial infarction within the past 6 months unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty

• No uncontrolled arrhythmia

• No second or third degree heart block or other clinically significant conduction system abnormality unless pacemaker is in place

Pulmonary:

• No severe chronic obstructive pulmonary disease requiring 3 or more hospitalizations within the past year

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No pre-existing grade 2 or greater peripheral neurotoxicity

• No other prior malignancy within the past 3 years except low-risk nonmelanomatous skin cancer; carcinoma in situ (e.g., breast, cervix, or bladder); or stage T1-2, low to moderate grade prostate cancer

• No significant wound infection

• No fistula

• No major wound dehiscence

• Nutritional status adequate

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Concurrent colony-stimulating factors for neutropenic fever during study chemoradiotherapy allowed

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy to head and neck

Surgery:

• See Disease Characteristics