|Phase II, Phase I||Treatment||Closed||18 and over||NCI||RTOG-8313|
I. Evaluate tumor control, patterns of failure, effect on the therapeutic ratio, and normal tissue effects of twice daily fractionation radiotherapy in patients with locally advanced squamous cell carcinoma of the upper respiratory and digestive tracts (URDT). II. Evaluate the influence of any region of origin of primary tumor on tumor control probability in patients undergoing this treatment. III. Evaluate the acute and chronic tolerance of URDT mucosa, cervical spinal cord, and salivary glands to twice daily fractionation.
See General Eligibility Criteria
See General Eligibility Criteria
General Eligibility Criteria:
Patients at least 18 years of age with histologically proven AJC Stage III or IV (Stage II base of tongue, hypopharynx, nasopharynx, or maxillary sinus) inoperable squamous cell carcinoma (or one of its histologic subtypes, including lymphoepithelioma/anaplastic) arising in the head/neck region (determination of specific site of origin within eligible areas is not a prerequisite). Patients must be medically able to withstand a course of definitive radiotherapy and have a Karnofsky performance status of at least 50%, adequate renal and hematologic function, and serum calcium within normal range. There may be no prior surgery for the tumor under study except biopsy obtained from the primary or regional lymph nodes. Patients treated in planned combined pre- or postoperative programs are excluded; however, neck dissections are allowed if lymph nodes become resectable (if tumor persists at the primary site six weeks following completion of irradiation, surgery may be performed). Prior radiotherapy to the head and neck is not allowed, nor is prior chemotherapy. Patients with any of the following conditions are ineligible: prior malignancy (other than skin cancer) unless the previous cancer was successfully treated surgically five years or more before the current tumor; clinical or radiographic evidence of metastases below the clavicle; or simultaneous primaries (unless both tumors are squamous in type, located within the head and neck area, and meet all criteria for eligibility).
The total number of patients required for study will depend on the dose at which toxicity is the limiting factor. A maximum of 254 patients will be accrued over 26 to 35 months. As of an April 1987 notification, accrual objectives have been revised to require at least 100 patients entered per arm. As of June 1987, the accrual to Arms I to IV is 70, 119, 127, and 104, respectively. Assuming 141 patients are needed and using the current 1:2 randomization to Arms II and IV, a total accrual of 196 patients is necessary. Using the average monthly accrual of 10.25 since the activation of Arm IV, this study is expected to achieve its accrual goals by November 1987. Once accrual is achieved, an additional 12 months of followup will be needed to evaluate late complications.
Randomized study. All patients are treated to a dose of 50.4 Gy on Regimen A; patients are randomized to one of the open arms for a boost dose to a reduced field (randomization subsequent to the start of irradiation is permitted if Radiotherapy has been administered for no more than 3 days and all treatment has been administered according to protocol specifications). An escalating dose design will be used, with initial randomization to Arms I, II, and III with a 1:1:2 weighting in favor of Arm III. If evaluation shows the higher dose to have acceptable toxicity, the lowest dose arm will be closed, the next arm opened, and patients randomized with a 1:1:2 weighting in favor of the highest dose arm. The process of escalation will continue until unacceptable toxicity levels are reached or until a dose of 86.40 Gy has been tested and found acceptable. As of February 1986, Arms I and III are closed, and patients are randomized to Arms II and IV with a 1:2 weighting in favor of Arm IV; Arm V is not yet open. Regimen A: Radiotherapy. Irradiation of the primary and regional nodes using Co60 or greater energy equipment with effective photon energies of 1.25 to 45 MeV or electron energies of 4 to 25 MeV. Arm I: Radiotherapy. Boost irradiation of the primary tumor to a total of 67.20 Gy. Arm II: Radiotherapy. Boost irradiation of the primary tumor to a total of 72.00 Gy. Arm III: Radiotherapy. Boost irradiation of the primary tumor to a total of 76.80 Gy. Arm IV: Radiotherapy. Boost irradiation of the primary tumor to a total of 81.60 Gy. Arm V: Radiotherapy. Boost irradiation of the primary tumor to a total of 86.40 Gy.Published Results
Cox JD, Pajak TF, Marcial VA, et al.: Dose-response for local control with hyperfractionated radiation therapy in advanced carcinomas of the upper aerodigestive tracts: preliminary report of radiation therapy oncology group protocol 83-13. Int J Radiat Oncol Biol Phys 18 (3): 515-21, 1990.[PUBMED Abstract]Related Publications
Cooper JS, Farnan NC, Asbell SO, et al.: Recursive partitioning analysis of 2105 patients treated in Radiation Therapy Oncology Group studies of head and neck cancer. Cancer 77 (9): 1905-11, 1996.[PUBMED Abstract]
Fu KK, Cox JD, Pajak TF: In response to bentzen and thames: regarding dose-response relationships for late radiation effects in the head and neck; an analysis of RTOG 83-13 trial. Int J Radiat Oncol Biol Phys 34(2): 524-525, 1996.
Cooper JS, Farnan NC, Asbell SO, et al.: A comparison of RPA-derived and AJC staging in head and neck cancers based on RTOG data. [Abstract] Int J Radiat Oncol Biol Phys 32 (suppl 1): A-2026, 275, 1995.
Fu KK, Cox JD: Late effects of hyperfractionated-radiotherapy for head and neck cancer--in response to Drs. Withers and Taylor, IJROBP 32:887-888; 1995. Int J Radiat Oncol Biol Phys 32 (4): 1266, 1995.[PUBMED Abstract]
Trial Lead Organizations
Radiation Therapy Oncology Group
|James Cox, MD, Protocol chair|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.