NCT00011999

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

Official Title:

Phase II Early Postoperative Paclitaxel Followed By Paclitaxel And Cisplatin Concurrent With Radiation Therapy For Resected, High Risk Squamous Carcinoma Of The Head And Neck

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.

Eligibility

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

Disease(s) and\or Condition(s)

Head and Neck Cancer

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: cisplatin
    • Description:
    • Arm Group Labels: Surgery, chemotherapy and radiation therapy
    • Type: DRUG
    • Name: paclitaxel
    • Description:
    • Arm Group Labels: Surgery, chemotherapy and radiation therapy
    • Type: PROCEDURE
    • Name: conventional surgery
    • Description:
    • Arm Group Labels: Surgery, chemotherapy and radiation therapy
    • Type: RADIATION
    • Name: radiation therapy
    • Description:
    • Arm Group Labels: Surgery, chemotherapy and radiation therapy
Sponsor
  • Radiation Therapy Oncology Group