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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
NCIC CTG PR.11: "A Phase III Study Of Active Surveillance Therapy Against Radical Treatment In Patients Diagnosed With Favourable Risk Prostate Cancer (START)"
The primary aim of this trial is to compare the survival of patients with favourable risk prostate cancer who are treated with radical prostatectomy or radical radiotherapy at the time of initial diagnosis to patients under active surveillance and selective intervention based on pre-specified biochemical, histological or clinical criteria.
Target accrual is 2130 patients. The protocol can be accessed through www.ctsu.org.
GOG-0249: "A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients With High Risk, Early Stage Endometrial Carcinoma"
The primary aim of this trial is to determine if treatment with vaginal cuff brachytherapy followed by three cycles of chemotherapy reduces the rate of recurrence or death (i.e., increases recurrence-free survival) when compared to pelvic radiation therapy. Survival and patterns of failure between the two treatment groups will be compared, as will physical functioning, fatigue, and neurotoxicity.
Target accrual is 562 patients. The protocol can be accessed through www.ctsu.org.
GOG-0258: "A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma"
The primary aim of this trial is to determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence or death (i.e., increases recurrence-free survival) when compared to chemotherapy consisting of carboplatin and paclitaxel for 6 cycles (control arm) in patients with Stages III-IVA endometrial carcinoma (<2 cm residual disease). Survival, adverse effects, and patient-reported quality of life will also be examined.
Target accrual is 804 patients. The protocol can be accessed through www.ctsu.org
GOG-0263: "Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy "
The primary aim of this trial is to determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in Stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy. Survival, adverse effects, and health-related quality of life will also be examined.
Target accrual is 534 patients. The protocol can be accessed through www.ctsu.org
ECOG E3F05: "Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas"
The primary aim of this trial is to determine whether the addition of temozolomide to fractionated radiotherapy improves the progression-free survival (PFS) of patients requiring treatment for low-grade gliomas. Survival based on 1p and 19q deletion status will be assessed. Toxicity, quality of life, and cognitive effects will also be evaluated.
Target accrual is 540 patients. The protocol can be accessed through www.ctsu.org
NCCTG N0577: "Phase III Intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma"
The primary aim of this trial is to determine whether there is a survival advantage for patients who receive concomitant temozolomide and radiotherapy followed by adjuvant temozolomide (Stupp regimen) over that observed in patients treated with radiotherapy alone (control). Survival based on t(1;19)(q10,p10) translocation status and MGMT promoter hypermethylation status will be assessed. Toxicity, quality of life, and neurocognitive effects will also be evaluated.
Target accrual is 488 patients. The protocol can be accessed through 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
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
SWOG S0809"A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)"
This trial is a Phase II study of adjuvant chemotherapy and chemoradiotherapy in patients with resected extrahepatic cholangiocarcinoma. Target accrual is 80 cases.
www.ctsu.org
NSABP B-43:"A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy"
The primary aim of this trial is to determine the value of trastuzumab given during radiation therapy (RT) compared to RT alone in preventing the subsequent occurrence of ipsilateral breast
cancer recurrence, ipsilateral skin cancer recurrence, or ipsilateral DCIS (IIBCR-SCR-DCIS) in women with HER2-positive DCIS resected by lumpectomy.
Target accrual is 2000 patients. The protocol can be accessed through www.ctsu.org
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