Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NRG Oncology Foundation, Inc.
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00047008
First received: October 3, 2002
Last updated: July 28, 2014
Last verified: May 2014

October 3, 2002
July 28, 2014
July 2002
June 2010   (final data collection date for primary outcome measure)
Overall Survival (3-year Rate) [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after 309 deaths have been reported. ] [ Designated as safety issue: No ]
Time from randomization to death due to any cause or last known date alive. Median survival was not reached, therefore 3-year survival rates are reported.
Not Provided
Complete list of historical versions of study NCT00047008 on ClinicalTrials.gov Archive Site
  • Local-regional Control [ Time Frame: From randomization to date of failure ] [ Designated as safety issue: No ]
    From randomization to date of failure (local or regional persistence/relapse) or death or last follow-up. Analysis occurs after 309 deaths have been reported.
  • Disease-free Survival [ Time Frame: From randomization to date of failure ] [ Designated as safety issue: No ]
    From randomization to date of failure (local or regional persistence/relapse, distant metastasis, secondary primary tumor or death) or last follow-up. Analysis occurs after 309 deaths have been reported.
  • Rate of Grade 3-5 Toxicity [ Time Frame: From start of treatment to last follow-up ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: From randomization to 5 years ] [ Designated as safety issue: No ]
  • Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes [ Time Frame: From randomization to date of death or last follow-up ] [ Designated as safety issue: No ]
  • Correlation of COX-2 With Outcomes [ Time Frame: From randomization to date of death or last follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer
A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas

RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer.

PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.

OBJECTIVES:

Primary

  • Compare overall survival of patients with stage III or IV squamous cell carcinoma of the head and neck treated with conventional vs accelerated radiotherapy and concurrent cisplatin with or without surgical resection.

Secondary

  • Compare local-regional control of disease and disease-free rates in patients treated with these regimens.
  • Compare the acute and late toxicity of these regimens in these patients.
  • Compare quality of life, perception of side effects, and performance status of patients treated with these regimens.
  • Determine whether epidermal growth factor receptor and cyclo-oxygenase-2 expressions are independent prognostic markers in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor site (larynx vs other), nodal stage (N0 vs N1 or N2a or N2b vs N2c or N3), and Zubrod performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo standard fractionation radiotherapy 5 days a week for 7 weeks. Patients also receive cisplatin IV on days 1, 22, and 43.
  • Arm II: Patients undergo accelerated fractionation radiotherapy 5 days a week for 3.5 weeks and then twice a day, 5 days a week, for 2.5 weeks. Patients also receive cisplatin IV on days 1 and 22.

Patients with biopsy-proven relapsed disease more than 3 months after completion of therapy undergo surgical resection of the primary tumor.

Quality of life is assessed at baseline, during one of the last 2 weeks of treatment, at 3 and 12 months, and then annually for 4 years.

Patients are followed at 6-8 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 720 patients (360 per treatment arm) will be accrued for this study within 3 years.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: cisplatin
    100 mg/m^2 intravenously on days 1, 22
  • Radiation: Standard fractionation RT
    Radiation will be delivered in 2 Gy per fraction, five fractions a week. The primary tumor and clinically/radiologically involved nodes will receive 70 Gy in 7 weeks and uninvolved nodes will receive 50 Gy in 5 weeks. The anterior lower neck field will be treated with 2 Gy per fraction at 3-cm depth to a total dose of 50 Gy.
  • Radiation: Accelerated fractionation radiation therapy
    Radiation to the initial target volume encompassing the gross and subclinical disease sites will be delivered in 1.8 Gy per fraction, five fractions a week to 54 Gy in 30 fractions over 6 weeks. At 32.4 Gy/18 Fx (i.e., latter part of week 4), the boost volume covering gross tumor and clinically/radiologically involved nodes will receive boost irradiation of 1.5 Gy/Fx as second daily fraction (at least 6 h interval) for a total of 12 treatment days (18 Gy total). The primary tumor and clinically/radiologically involved nodes will receive 72 Gy in 42 fractions over 6 weeks and uninvolved nodes will receive 54 Gy in 6 weeks. Clinically/radiologically negative posterior neck should receive a minimum dose of 50.4 Gy at 3 cm. The anterior lower neck field will be treated with 1.8 Gy per fraction at 3-cm depth to a total dose of 50.4 Gy in 28 fractions in 5.6 weeks.
  • Procedure: Conventional surgery for select patients

    Surgical removal (salvage resection) of the primary tumor should be performed if biopsy-proven cancer remains more than three months after completion of therapy. The nature of the surgical resection should be dictated by the extent of tumor at the initial evaluation. The operation should be conducted using accepted criteria for primary surgical treatment of the cancer.

    A planned neck dissection for patients with multiple neck nodes or with lymph nodes exceeding 3 cm in diameter (N2a, N2b, N3) is mandatory, regardless of the clinical and/or radiographic response. A neck dissection is required for patients with N1 disease if a palpable or worrisome radiographic abnormality persists in the neck six weeks after completion of therapy. Surgery should be performed within 2 weeks once the decision for neck dissection is made.

  • Standard fractionation RT + cisplatin
    Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
    Interventions:
    • Drug: cisplatin
    • Radiation: Standard fractionation RT
    • Procedure: Conventional surgery for select patients
  • Experimental: Accelerated fractionation RT + cisplatin
    Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
    Interventions:
    • Drug: cisplatin
    • Radiation: Accelerated fractionation radiation therapy
    • Procedure: Conventional surgery for select patients

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
743
Not Provided
June 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx

    • Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0)
  • No metastases below the clavicle or more distant by clinical exam or radiology

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 mg/dL
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no greater than 2 times upper limit of normal

Renal

  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 50 mL/min
  • Calcium normal

Cardiovascular

  • No symptomatic coronary artery disease (angina)
  • No myocardial infarction within the past 6 months

Other

  • No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
  • No simultaneous primary tumors
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the head and neck except radioactive iodine therapy

Surgery

  • No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal sampling of neck disease

    • No radical or modified neck dissection
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00047008
RTOG 0129, CDR0000257233, RTOG-H-0129, RTOG-DEV-1069
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
  • National Cancer Institute (NCI)
  • NRG Oncology Foundation, Inc.
Principal Investigator: Phuc Felix Nguyen-Tan, MD CHUM Hospital Notre Dame
Radiation Therapy Oncology Group
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP