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Enrollment procedures and data collection for these studies must be done via CTSU, not RTOG; however, RTOG institutions that enter patients on any CTSU trial will receive credit toward RTOG membership accrual requirements
www.ctsu.org
CALGB 80101: "Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma"
www.ctsu.org
MDA-3410: A Prospective Randomized Phase III Trial Comparing Consolidation Therapy with or without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer
www.ctsu.org
NCIC-MA.20: A Phase III Study of Regional Radiation Therapy in Early Breast Cancer
www.ctsu.org
SWOG S0424: “Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer in Smoking and Non-Smoking Women and Men”
This study of patients with newly diagnosed stage I-III non-small cell cancer looks at markers in lung cancer tissue and alterations in specific genes to determine whether these factors differ by gender and smoking status. The study also examines patient self-report questionnaire data on items such as active and passive smoking, economic and educational status, other carcinogenic exposures, and reproductive factors. Target accrual is 720 cases.
www.ctsu.org
NCCTG 0574: "Phase III Randomized Trial of Whole Brain Radiation in Addition to Radiosurgery in Patients with One to Three Cerebral Metastases"
Patients must have one to three presumed brain metastases from a histologically confirmed extra-cerebral tumor site (e.g. lung, breast, prostate, etc.). Patients must be able to be treated with either a gamma knife or a linear accelerator-based radiosurgery system and must have an ECOG performance status of 0, 1, or 2. According to the NCCTG protocol, "This study is designed to test the hypothesis that in patients with one to three brain metastases, WBRT adds no additional benefit to SRS. Common Toxicity Criteria scoring, QOL questionnaires, functional independence measurements, neurocognitive testing, and post-treatment adverse events will be obtained at serial follow-up visits in order to ascertain any differences in long-term outcome." Target accrual is 458. The protocol can be accessed at
www.ctsu.org
CALGB 140503, "A Phase III Randomized Trial Of Lobectomy Versus Sublobar Resection For Small (< 2 Cm) Peripheral Non-Small Cell Lung Cancer"
In this trial, patients with small peripheral (< 2 cm) NSCLC will be randomly assigned to either lobectomy or a sublobar resection. If limited resection is proven to be equivalent to lobectomy, it offers several advantages including:
- Preservation of pulmonary function;
- Wider applicability of minimal access surgical techniques with attendant reduced hospitalization and enhanced QOL;
- Increased likelihood of the possibility of a curative surgical intervention in the event of a secondary primary lung cancer.
Target accrual is 1297. The protocol can be accessed at www.ctsu.org
CALGB 90202: "A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone"
This study is designed to evaluate the efficacy of early versus delayed zoledronic acid (Zometa® ) in men with prostate cancer metastatic to bone. The study will include men with prostate cancer and radiographically documented bone metastases who have started androgen deprivation therapy within 3 months prior to study entry." Target accrual is 680 patients. The protocol can be accessed at www.ctsu.org
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