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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating patients with prostate cancer.
- Assess the impact of increasing the radiation dose 10 Gy on biochemical or clinical progression-free survival at 5 years in patients with unfavorable-risk prostate cancer receiving prolonged hormone therapy.
- Evaluate overall and specific survival.
- Assess acute and late toxicities of different modalities (conformal or intensity-modulated radiotherapy).
- Evaluate toxicities of the different doses with respect to hormonal therapy.
- Assess the quality of life (QLQ-C30 and PR 25).
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
- Arm II: Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
In both arms, patients receive goserelin subcutaneously once every 3 months for up to 3 years.
After completion of study treatment, patients are followed up periodically for 10 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
3-dimensional conformal radiation therapy, intensity-modulated radiation therapy
Federation Nationale des Centres de Lutte Contre le Cancer
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:19:43-0400
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CONFORMAL RADIOTHERAPY that combines several intensity-modulated beams to provide improved dose homogeneity and highly conformal dose distributions.
Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
Organs which might be damaged during exposure to a toxin or to some form of therapy. It most frequently refers to healthy organs located in the radiation field during radiation therapy.
Drugs used to protect against ionizing radiation. They are usually of interest for use in radiation therapy but have been considered for other, e.g. military, purposes.
A therapeutic approach, involving chemotherapy, radiation therapy, or surgery, after initial regimens have failed to lead to improvement in a patient's condition. Salvage therapy is most often used for neoplastic diseases.
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...