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Clinical Trials (PDQ®)

Phase III Randomized Comparison of Neutron Therapy vs Conventional Photon Therapy in Patients with Osteosarcoma, Soft Tissue Sarcoma, Melanoma, and Thyroid and Renal Cell Carcinomas (Summary Last Modified 05/89)

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overNCIRTOG-8609P
RTOG-86-09-P

Objectives

I.  Compare, in a randomized Phase III multi-institutional setting, neutron 
therapy vs. conventional photon irradiation with regard to local clearance 
(complete regression), local control, survival duration, and complications of 
therapy in patients with osteosarcoma, soft tissue sarcoma, melanoma, renal 
cell carcinoma, and thyroid carcinoma.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 18 years old (no 
upper age limit) with soft tissue sarcoma, osteosarcoma, chondrosarcoma, 
melanoma, thyroid (follicular papillary and anaplastic) carcinoma, or clear 
cell adenocarcinoma of the kidney provided there are no more than 2 measurable 
active sites of the tumor including the primary (several nodes in the same 
region or an aggregate of lung metastases that can be treated conveniently as 
a single target volume are considered a single site).  Primary or metastatic 
tumors may be located in the following regions:  head and neck, lung, soft 
tissues and lymph nodes, bones, and pelvis.  Patients with metastatic disease 
in the brain, liver, or upper abdomen (between the diaphragm and the iliac 
crest) are specifically excluded.  Patients with a previous cancer must 
demonstrate no current activity of this other tumor.  No concurrent 
chemotherapy is allowed, and patients must be at least 2 weeks beyond the 
conclusion of previous chemotherapy.  There may have been no previous 
radiotherapy of the anticipated treatment volume.  The Karnofsky performance 
status must be 60 or better.  Patients may not have been previously entered on 
this study.

Expected Enrollment

Initially, 112 evaluable patients will be randomized over about 2.5 years.  If 
the neutron therapy arm reveals a 30% improvement at 80% power, an additional 
36 evaluable patients will be randomized over about 0.8 year.

Outline

Randomized study.
Arm I:  Radiotherapy.  Involved-field irradiation using neutrons as approved 
by the NCI 1985 contract.
Arm II:  Radiotherapy.  Involved-field irradiation using Co60 gamma rays or 
photons of 4 MeV or greater (6 MeV minimum for disease in lung or pelvis.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Lester Peters, MD, Protocol chair
Ph: 61-3-9656-1004
Email: lester.peters@petermac.org

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.

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