Induction FOLFOX followed by preoperative hyperfractionated radiotherapy plus bolus XXXX in locally advanced rectal carcinoma: single arm phase I-II study.

@entity5 @entity1 @entity137 @entity1487
Induction chemotherapy has many benefits of in locally advanced @entity5 (LARC); one of these is the better control of distant failure. Hyperfractionated radiotherapy (HFRT) is new approach still on evaluation in preoperative setting of @entity5 . We aimed to evaluate the efficacy of induction FOLFOX followed by HFRT in LARC. From September 2011 to December 2013, 27 @entity1 with LARC were enrolled in this prospective, phase I-II study. Induction FOLFOX bolus was given for two cycles followed by HFRT (1.5  Gy twice day for 30 fractions over 3  weeks for a total of 45  Gy). @entity1487 ( @entity1487 ) bolus was administrated during first and last 3  days of radiotherapy. Surgical resection was performed in 4-5  weeks further and followed by adjuvant FOLFOX bolus regimen. Twenty-one (77.8  %) @entity1 were males and 22. 2  % of @entity1 were females, and the median age at diagnosis was 46  years. Low sited @entity5 was the most presenting site (55.6  %). Clinically positive lymph nodes were presented in 70.4  % of @entity1 . Twenty @entity1 (74.1  %) underwent sphincter sparing procedure. Pathological complete response (pCR) was achieved in seven @entity1 (25.9  %). Tumor and nodal downstaging were recorded in (70.3  %) and (42.1  %) of @entity1 , respectively. Acute and late @entity137 were in acceptable range. Two-year disease-free survival was 70.2  %, and overall survival was 87.5  %. Induction FOLFOX followed by HFRT and concurrent @entity1487 improves pCR in LARC, and this combination was feasible with acceptable @entity137 . Further evaluations are mandatory for this new approach.
