Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy alone is more effective then chemotherapy plus radiation therapy in treating rectal cancer.
PURPOSE: This randomized phase II/III trial studies how well chemotherapy alone compared to chemotherapy plus radiation therapy works in treating patients with rectal cancer undergoing surgery.
Drug: leucovorin calcium
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II/III Trial of Neoadjuvant FOLFOX, With Selective Use of Combined Modality Chemoradiation Versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection With Total Mesorectal Excision|
- Pelvic R0 resection rate (Phase II) [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]
- DFS (Phase III) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
- Time to local recurrence (TLR) [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
- Pathologic complete response [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
- Adverse event (AE) profiles [ Time Frame: Up to 8 years ] [ Designated as safety issue: Yes ]
- Rates of receiving pre- or post-operative 5FUCMT [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Experimental: Group 1
Patients receive neoadjuvant chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously on days 1-2. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with at least 20% of tumor regression undergo low-anterior resection (LAR) with total mesorectal excision (TME). Patients with less than 20% of tumor regression undergo chemoradiation as in group 1 before proceeding to LAR with TME.
Given IVDrug: leucovorin calcium
Given IVDrug: oxaliplatin
Experimental: Group 2
Patients receive fluorouracil IV continuously 7 days a week for 5.5 weeks or capecitabine orally (PO) twice daily (BID) 5 days a week for 5.5 weeks. Patients also undergo 3-dimensional conformal or intensity-modulated radiation therapy 5 days a week for approximately 5.5 weeks. Patients then undergo LAR with TME.
Given PODrug: fluorouracil
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