A Pilot Study Of Folfox With Or Without Radiation In Treating Patients With Locally Advanced Rectal Cancer

e14147 Background: Preoperative 5FU-based chemo plus radiation therapy is standard for patients (pts) with locally advanced rectal cancer (RC). We conducted a pilot feasibility trial of adding the third generation drug oxaliplatin to the standard treatment to see whether the treatment outcome can be improved and the place of RT can be replaced. Methods: Pts with clinical stage II-III resectable RC were treated with 4 cycles of FOLFOX (CT) or 5 cycles of FOLFOX with radiation (2Gy/fraction, total 46Gy, CRT). Pts then were re-imaged and had repeat colonoscopy with MRI to assess the primary tumor response. Those with progressive disease in FOLFOX group were to be referred for pre-op 5FU plus RT, followed by surgery, and those with clinical regression/stable disease were to have surgery without pre-op RT. Post-op 5FU plus RT was planned for any pts who did not have an R0 resection. 7-8 cycles of FOLFOX were recommended in Post-op chemo. The primary endpoint was the objective response rate. Secondary outcomes were the pathologic CR rate, the 3-year disease free survival and local recurrence (LR) rate. Results: Of 51 pts were accrued since April 2007, 25 have completed pre-op RCT, 26 who have completed pre-op CT, 7 of 25 RCT pts (28%) had a path CR, however no pts with CT had path CR, the difference was significant. ORR was 92%, 80.8% and disease control rate (DCR) 96%, 96.2% respectively, there was no difference between the two groups. The quality of life was better and the in-hospital time was shorter the CT alone group. Local and distant recurrence rate data are immature. But so far, no recurrence was found in the CT group, which indicated the potential benefit of CT alone in the adjuvant setting. Conclusions: Preliminary results of this pilot trial depicts that preoperative FOLFOX alone without RT achieves a high rate of DCR. And FOLFOX with RT achieves a high rate of CR. Further phase III trials are warranted.