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Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about 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 committed 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 health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including 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 permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally 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. Test subjects typically receive the most expert healthcare available for their Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid 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. Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
2. CT Scans in Guiding the Treatment of Patients With Prostate Cancer Who are Undergoing Radiation Therapy
3. Bortezomib and Mitoxantrone in Treating Patients With Advanced or Metastatic Androgen-Independent Prostate Cancer
4. Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer
5. Assessing Quality of Life of 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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