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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00719303 |
RATIONALE: A healthy lifestyle and counseling after treatment may improve progression-free survival in patients with previously treated cancer.
PURPOSE: This randomized phase III trial is studying diet and physical activity changes to see how well they work compared with usual care in improving progression-free survival in patients with previously treated stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.
Condition | Intervention | Phase |
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Ovarian Cancer Peritoneal Cavity Cancer |
Procedure: behavioral dietary intervention Procedure: compliance monitoring Procedure: counseling Procedure: educational intervention Procedure: exercise intervention Procedure: laboratory biomarker analysis Procedure: quality-of-life assessment Procedure: questionnaire administration |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized |
Official Title: | Can Diet and Physical Activity Modulate Ovarian and Primary Peritoneal Cancer Progression-Free Survival? |
Estimated Enrollment: | 1428 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial cancer or primary peritoneal carcinoma, including any of the following subtypes:
Patients must have completed all primary chemotherapy and consolidation therapy (if administered) more than 12 weeks ago but less than 24 months ago and are in complete remission
No clinical evidence of persistent or recurrent disease based on CA 125 level and CT scan
PATIENT CHARACTERISTICS:
No other chronic disease that would preclude randomization into a lifestyle intervention trial including, but are not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000594600, GOG-0225 |
Study First Received: | July 18, 2008 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00719303 |
Health Authority: | Unspecified |
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer peritoneal cavity cancer ovarian serous cystadenocarcinoma ovarian endometrioid adenocarcinoma |
ovarian mucinous cystadenocarcinoma ovarian undifferentiated adenocarcinoma ovarian clear cell cystadenocarcinoma ovarian mixed epithelial carcinoma Brenner tumor |
Cystadenocarcinoma, Serous Ovarian cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Disease Progression Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Abdominal Neoplasms |
Carcinoma, Endometrioid Dental Caries Carcinoma Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Adenocarcinoma Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |