Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Memorial Sloan Kettering Cancer Center
With
OBJECTIVES: Primary * Determine whether neoadjuvant chemotherapy comprising oxaliplatin, fluorouracil, leucovorin calcium (FOLFOX), and bevacizumab can be substituted for pelvic radiotherapy without compromising R0 resection rates in patients with locally advanced rectal cancer. Secondary * Determine whether a 3-year local recurrence rate of ≤ 10% can be achieved in patients treated with this regimen. * Determine the proportion of patients who achieve a complete pathologic response after treatment with this regimen. OUTLINE: This is a non-randomized, open-label, pilot study. * Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 10 minutes on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2 in weeks 1, 3, 5, and 7. Patients then receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2 in weeks 9 and 11. Treatment continues in the absence of disease progression or unacceptable toxicity. Within 3 weeks after completion of neoadjuvant chemotherapy, patients undergo restaging evaluation. Patients with no evidence of disease progression by endorectal ultrasound (ERUS), pelvic MRI, and CT scan of the chest/abdomen AND who remain candidates for R0 resection may proceed directly to surgical resection within 4-6 weeks after completion of neoadjuvant chemotherapy. Patients with progressive disease who are not candidates for an R0 resection, proceed to neoadjuvant chemoradiotherapy. * Neoadjuvant chemoradiotherapy: Patients undergo pelvic radiotherapy 5 days a week and receive concurrent fluorouracil IV continuously for 5½ weeks. Within 4-7 weeks after completion of chemoradiotherapy, patients undergo surgical resection. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 5 years. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
