At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, or larynx
- ✓Stage III or IV disease (T2 N2-3 M0 or T3-4 any N M0)
- ✓No distant metastases below clavicle on clinical exam or imaging
- ✓Age 18 years or older
- ✕Prior chemotherapy
- ✕Prior head and neck radiotherapy (except radioactive iodine)
- ✕Prior surgery to primary tumor or nodes except diagnostic biopsy or nodal sampling (no radical or modified neck dissection)
- ✕Other invasive malignancy within past 3 years except nonmelanoma skin cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas
In Brief
A Phase 3 clinical trial evaluating cisplatin, Standard fractionation RT, and 2 other interventions for Head and Neck Cancer. Completed, enrolled 743 participants across 195 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
100 mg/m\^2 intravenously on days 1, 22
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 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.
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.