Phase III Randomized Study of Interstitial Thermoradiotherapy vs Interstitial Radiotherapy Alone for Metastatic, Recurrent, or Persistent Tumors (Summary Last Modified 09/90)
Basic Trial Information
|Phase III||Treatment||Completed||over 18||NCI||RTOG-8419|
I. Determine whether interstitial thermoradiotherapy increases complete tumor regression rates in accessible measurable lesions as compared to interstitial radiotherapy alone. II. Compare the response of the skin and subcutaneous tissues to thermoradiotherapy and radiotherapy alone.
Histologically proven epithelial or mesenchymal malignancy Metastatic, recurrent, or unresponsive to conventional therapy Brachytherapy considered appropriate treatment Disease must be bidimensionally and, if possible, tridimensionally measurable (3 dimensional measurements from CT scans acceptable) Biopsy of metastatic lesions not required Histologic confirmation of recurrent tumors required Lesion or lesion clusters must be encompassable within the inplant volume both for hyperthermia and radiotherapy Tumors most likely to be treated: Head and neck (oral cavity, oropharynx, salivary glands, metastatic neck nodes) Breast (primary, chest wall recurrence, metastatic or recurrent nodes) Soft tissue sarcoma Other sites suitable for brachytherapy
Biologic therapy: Not specified Chemotherapy: At least 2 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No more than 80 Gy of prior radiotherapy allowed No prior hyperthermia to the tumor-bearing volume Surgery: Not specified
Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 6 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
50 patients per arm will be required; accrual will be completed in approximately 1.5 years. As of January 1990, 89 patients had been accrued to the Phase II portion of the study. 95 additional patients are now required to complete the Phase III portion.
Randomized study. Patients with more than one lesion are eligible for multiple randomizations. Arm I: Radiotherapy. Interstitial irradiation of tumor with Ir192 seeds in nylon ribbons or Ir192 wires. Arm II: Thermoradiotherapy. Interstitial tumor irradiation plus interstitial hyperthermia using electromagnetic fields from coaxial microwave antennae or RF electric currents (frequency of 300-2,450 MHz for microwaves and 0.1-1.0 MHz for RF currents); the ferromagnetic seed hyperthermia technique may also be used.
Emami B, Scott C, Perez CA, et al.: Phase III study of interstitial thermoradiotherapy compared with interstitial radiotherapy alone in the treatment of recurrent or persistent human tumors. A prospectively controlled randomized study by the Radiation Therapy Group. Int J Radiat Oncol Biol Phys 34 (5): 1097-104, 1996.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Radiation Therapy Oncology Group
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.