Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Objectives

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.

Entry Criteria

Disease Characteristics:

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

Prior/Concurrent Therapy:

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

Patient Characteristics:

Age:
  18 and over

Performance status:
  Karnofsky 60-100%

Life expectancy:
  At least 6 months

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Expected Enrollment

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.

Outline

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

Bahman Emami, MD, Protocol chair		Ph: 708-216-2562

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