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| 0518 |
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| Number: | RTOG 0518 |
| Title: |
A Phase III Randomized Trial to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer
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| Eligibility: |
Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 12 months of registration; Any one of the following clinical stages:
- >T3 disease, any N stage, M0 with any Gleason score and any PSA;
- <T3 stage, any N stage, M0 with Gleason's score >8 and any PSA;
- <T3 stage, any N stage, M0 with Gleason's score 7 and PSA >15 nanograms/ml;
- <T3 stage, any N stage, M0 with Gleason score <7 and PSA >20 nanograms/ml;
A negative bone scan for metastatic disease. It is mandatory that the treating physician determine the planned duration of LHRH therapy prior to the site registering the patient (minimum 1 year of therapy). If patient is receiving pretreatment LHRH therapy, it must have begun <6 months prior to registration. If pelvic RT has started, it must have begun <8 weeks prior to registration. Zubrod Performance Status 0-1 within 16 weeks prior to registration; Age >18; Serum creatinine within 4 weeks prior to registration; Corrected serum calcium >8.4 and <10.6 mg/dl within 8 weeks prior to registration. Patients who are sexually active must be willing/able to use medically acceptable forms of contraception, as the treatment involved in this study may be significantly teratogenic. Patient agrees to refrain from using all products listed in Section 9.2, "Non-permitted Supportive Therapy." Post-prostatectomy patients are eligible. Patient must sign study specific informed consent prior to study entry.
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| Treatment: |
For patients receiving concurrent radiation therapy and LHRH therapy:
Arm 1:
Zoledronic acid plus
vitamin D and calcium supplement
Arm 2:
Vitamin D and calcium supplement
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| Study size: | 1272 |
| RTOG 0517 |
| Number: |
0517 |
| Title: |
Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases from Lung, Breast, and Prostate Cancer |
| Eligibility: |
Histologically or cytologically proven diagnosis of solid tumor malignancy of lung, breast, or prostate prior to registration; appropriate diagnosis for protocol entry, based upon the diagnostic workup specified in the protocol; > 18 years of age;
Zubrod performance status 0-2 for patients with breast or prostate primaries; Zubrod performance status 0-1 for patients with lung primaries; adequate bone marrow function as defined in the protocol; serum creatinine < 3 mg/dL (265 µmol/L) total bilirubin < 2.5 mg/dL (43 µmol/L) and within 2 weeks prior to registration; pregnancy test for women of childbearing potential within 2 weeks prior to registration; patients receiving systemic chemotherapy or hormonal therapy are eligible for this study (if patients have undergone CyberKnife treatment, treatment must be completed > 14 days prior to registration); patients may have received prior oral bisphosphonate therapy, such as Fosamax® or similar medications; all bisphosphonates other than the study drug must be discontinued prior to registration; women of childbearing potential and male participants must agree to practice an adequate means of birth control throughout their participation in the study; patients must sign study specific informed consent prior to study entry; patients with brain metastases and/or spinal cord compression are excluded (patients with no evidence of disease in the brain after treatment for brain metastases are eligible); patients with painful bone metastases are not permitted until these bone metastases are successfully treated (for example by external beam irradiation) prior to registration, and the patient has stable pain for at least 2 weeks after that treatment (Stable pain is defined for this study as a patient response of 1, 2, or 3 on Questions 4 and 5 of The Brief Pain Inventory (BPI); patients who have had prior treatment with Strontium-89 or Samarium-153 for bone metastases are excluded; no treatment for more than 6 months with IV bisphosphonates prior to study entry; no treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to registration; no evidence in the six months prior to study entry of uncontrolled congestive heart failure, hypertension refractory to treatment, or symptomatic coronary artery disease; no current, active dental problems within 4 weeks of registration, including infection of the teeth or jawbone (maxilla or mandible); dental or fixture trauma; current or prior diagnosis of osteonecrosis of the jaw (ONJ); exposed bone in the mouth; or slow healing after dental procedures; no dental surgery (e.g., extractions, implants) within 6 weeks of study entry and while receiving study treatment; patients with Acquired Immune Deficiency Syndrome (AIDS) are excluded; pregnant or lactating patients are excluded.
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| Treatment: |
Arm 1:
Zoledronic acid plus
vitamin D and calcium supplement
Arm 2:
Zoledronic acid plus
vitamin D and calcium supplement plus
single dose of Sr-89 or Sm-153
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| Study size: |
352 |
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