5-FU, Aflibercept, and Radiation (RT) for Preoperative and Postoperative Patients With Stage II/III Rectal Cancer
|Rectal Cancer||Radiation: Radiation Drug: Aflibercept Procedure: Surgery Drug: FOLFOX6||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of 5-Fluorouracil (5-FU), Aflibercept, and Radiation for the Preoperative and Adjuvant Treatment of Patients With Stage II/III Rectal Cancer|
- Pathologic Complete Response Rate [ Time Frame: Between days 57 and 98 after preoperative chemotherapy ]The Pathologic Complete Response (pCR) Rate is defined as the number of pathologic complete responders among all patients evaluable for response, including evaluable patients who did not proceed to surgery. A pCR is defined as the absence of any residual abnormality detected in a pathological specimen.
- Overall Survival [ Time Frame: Every 3 months (±1 month) following documented progression, up to 5 years or death, whichever comes first. ]Measured from date of first protocol treatment until date of death.
- Overall Survival Probability at 6 and 12 Months [ Time Frame: up to 1 year ]The probability of overall survival at 6 months and 12 months from date of first protocol treatment until date of death.
- Sphincter Preservation Rate [ Time Frame: Between days 57 and 98 after preoperative chemotherapy. ]The percentage of patients who had Low Anterior Resection during surgery..
- Disease-Free Survival [ Time Frame: Patients without evidence of progression will be followed every 3 months (±1 month) from date of last dose of study drug during Years 1-2, every 6 months during Years 3-4, and annually thereafter or until disease progression, estimated 5 years. ]
- Disease Free Survival Probability at 6 and 12 Months [ Time Frame: Up to 1 year ]The probability of disease free survival at 6 and 12 months after initiating protocol treatment.
- The Number of Participants Who Experienced Serious or Non-Serious Adverse Events as a Measure of Safety. [ Time Frame: weekly for 6 weeks pre-op then every 2 weeks post-op, approximately 36 weeks ]Adverse events and serious adverse events (AEs and SAEs) were graded according to National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.0. Specific AE and SAE terms are provided in the Adverse Event module.
|Study Start Date:||January 2013|
|Study Completion Date:||September 2015|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Preoperative Chemoradiation: (6 weeks)
Surgery at least 6 weeks after last day of aflibercept: Patients will undergo abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines.
Postoperative Chemotherapy and Aflibercept Treatments (four 28-day cycles):
Other Names:Procedure: Surgery
Abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelinesDrug: FOLFOX6
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749956
|United States, Florida|
|Florida Cancer Specialists|
|Fort Myers, Florida, United States, 33916|
|Woodlands Medical Specialists|
|Pensacola, Florida, United States, 32503|
|Florida Cancer Specialists|
|St. Petersburg, Florida, United States, 33705|
|Space Coast Cancer Center|
|Titusville, Florida, United States, 32796|
|United States, Kentucky|
|Baptist Hospital East|
|Louisville, Kentucky, United States, 40207|
|United States, Ohio|
|Oncology Hematology Care, Inc.|
|Cincinnati, Ohio, United States, 45242|
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States, 71304|
|United States, South Carolina|
|South Carolina Oncology Associates|
|Columbia, South Carolina, United States, 29210|
|United States, Tennessee|
|Tennessee Oncology - Chattanooga|
|Chattanooga, Tennessee, United States, 37404|
|Tennessee Oncology, PLLC|
|Nashville, Tennessee, United States, 37203|
|United States, Virginia|
|Virginia Cancer Institute|
|Richmond, Virginia, United States, 23230|
|Study Chair:||Johanna C Bendell, M.D.||SCRI Development Innovations, LLC|