Combination Chemotherapy in Treating Patients Undergoing Surgery for Rectal Cancer
Recruitment status was: Recruiting
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may kill more tumor cells and may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving oxaliplatin, leucovorin, and fluorouracil after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy works in treating patients undergoing surgery for rectal cancer.
Drug: FOLFOX regimen
Drug: leucovorin calcium
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment
Procedure: therapeutic surgical procedure
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Open- Labeled, Prospective Study to Determine the Efficacy of Pre- Operative Chemotherapy With Six Cycles of Modified FOLFOX 6 Followed by Total Mesorectal Excision (TME) Followed by an Additional Six Cycles of FOLFOX 6|
- Pathologic response and complete response rate
- Locoregional control
- Complete resectability rates
- Ability of high resolution pelvic MRI to assess locoregional response and predict adequacy of the circumferential margin after total mesorectal excision (TME)
- Sphincter preservation
- Disease-free survival
- Overall survival
- Preservation of sexual, urinary, and bowel function
- Patterns of disease failure, including local recurrence and distant metastasis assessed by CT scan
- Quality of life at baseline and annually following TME
- Comparison of preoperative stage with post-treatment pathologic stage
- Comparison of preoperative staging with pelvic MRI vs endorectal ultrasound
|Study Start Date:||January 2009|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
- To assess the complete pathologic response rate in patients with rectal cancer treated with modified neoadjuvant FOLFOX 6 chemotherapy followed by total mesorectal excision and adjuvant modified FOLFOX 6 chemotherapy.
- To observe the overall pathologic response rate in these patients.
- To correlate pathologic staging with preoperative ultrasound and pelvic MRI staging.
- To assess toxic side effects of these regimens in these patients.
- To assess patterns of disease relapse, disease-free survival outcomes, and overall survival outcomes of these patients.
- Neoadjuvant therapy: Patients receive modified FOLFOX 6 chemotherapy comprising oxaliplatin and leucovorin calcium IV over 2 hours on day 1 and continuous fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to surgery.
- Surgery: Patients undergo total mesorectal excision by anterior resection or an abdominal perineal resection within 4 weeks after completion of neoadjuvant therapy.
- Adjuvant therapy: Within 4 weeks after surgery, patients receive modified FOLFOX 6 chemotherapy comprising oxaliplatin and leucovorin calcium IV over 2 hours on day 1 and continuous fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life assessment questionnaires at baseline and at each follow-up visit.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831181
|United States, New York|
|Beth Israel Medical Center - Philipps Ambulatory Care Center||Recruiting|
|New York, New York, United States, 10003|
|Contact: Clinical Trials Office - Beth Israel Medical Center - Philipps 212-844-8060|
|St. Luke's-Roosevelt Hospital Center - Roosevelt Division||Recruiting|
|New York, New York, United States, 10019|
|Contact: Tahir Mirzoyev 212-523-7289|
|Principal Investigator:||Peter Kozuch, MD||Beth Israel Medical Center|