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
- 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: 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
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and annually thereafter.
Masking: Open Label, Primary Purpose: Treatment
Pathologic response and complete response rate
Peter Kozuch, MD
Beth Israel Medical Center
|St. Luke's-Roosevelt Hospital Center - Roosevelt Division||New York, New York 10019|
|Beth Israel Medical Center - Philipps Ambulatory Care Center||New York, New York 10003|