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Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer Clinical research trials and Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer. Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer  Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer
Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer
For Condition: adenocarcinoma of the prostate,stage 2 prostate cancer,stage 3 prostate cancer
Status: Recruiting
Sponsor(s): Fox Chase Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in treating prostate cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of two radiation therapy regimens in treating patients who have stage II or stage III prostate cancer.
Details: OBJECTIVES: - Compare the efficacy of conventional intensity-modulated radiotherapy (IMRT) vs hypofractionated IMRT, in terms of failure-free survival in patients with stage II or III prostate cancer. - Compare the local control, freedom from distant metastasis, and overall survival of patients treated with these regimens. - Determine local failure, using biopsy of the prostate, when objective tests (prostate-specific antigen, ultrasound, and digital rectal exam) suggest relapse in these patients. - Compare the extent of disease eradication using biopsy of the prostate at 2 years after therapy in these patients. - Compare the quality of life of patients treated with these regimens. - Determine the impact of these regimens on patient preferences and utilities. OUTLINE: This is a randomized study. Patients are stratified according to pretreatment prostate-specific antigen (no greater than 10 ng/mL vs greater than 10 to 20 ng/mL vs greater than 20 ng/mL), Gleason score (5-7 vs 8-10), and risk status (high risk vs intermediate risk). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo conventional intensity-modulated radiotherapy (IMRT) 5 days a week for 7.5 weeks in the absence of disease progression or unacceptable toxicity. - Arm II: Patients undergo hypofractionated IMRT 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients with high-risk disease also undergo androgen ablation therapy for 2 years. Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 4 years. Patients are followed at 3 months, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Clinical stage T1b-T3c disease - No clinical or radiographic evidence of metastasis - Prostate-specific antigen (PSA) less than 80 ng/mL - Gleason score at least 5 - One of the following criteria must be met: - PSA greater than 10 ng/mL - Gleason score greater than 6 - T2b or greater palpable disease - Three or more biopsy cores involved with a Gleason score of at least 5 PATIENT CHARACTERISTICS: Age - Not specified Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - No other medical condition that would preclude study participation - No other active malignancy within the past 5 years except nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic leukemia) - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - No more than 4 months of prior androgen ablation therapy - Concurrent neoadjuvant androgen ablation therapy is allowed for high-risk disease only Radiotherapy - No prior pelvic radiotherapy Surgery - No prior or planned radical prostate surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlanPollack, Study Chair, Fox Chase Cancer Center
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Alan Pollack 215-728-2940
Additional Information:
Study ID Numbers: CDR0000304712; FCCC-02602
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062309
Other Stage 3 Prostate Cancer Studies:
1. Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer
2. Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
3. SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
4. Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer
5. Radiation Therapy in Treating Patients With Prostate Cancer
Related Studies:
Other stage 3 prostate cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer
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