PURPOSE: @entity1 with locally advanced @entity189 are at risk for both local recurrence and distant metastases. We demonstrated the efficacy of preoperative hyperfractionated accelerated radiotherapy (HART). In this Phase I trial, we aimed at introducing chemotherapy early in the treatment course with both intrinsic antitumor activity and a radiosensitizer effect. METHODS AND MATERIALS: Twenty-eight @entity1 (19 males; median age 63, range 28-75) with advanced @entity189 (cT3: 24; cT4: 4; cN+: 12; M1: 5) were enrolled, including 8 @entity1 treated at the maximally tolerated dose. Escalating doses of @entity2600 (30-105 mg/m(2)/week) were given on Days 1, 8, and 15, and concomitant HART (41.6 Gy, 1.6 Gy bid x 13 days) started on Day 8. Surgery was to be performed within 1 week after the end of radiochemotherapy. RESULTS: Twenty-six @entity1 completed all preoperative radiochemotherapy as scheduled; all @entity1 underwent surgery. Dose-limiting @entity137 was @entity294 Grade 3 occurring at dose level 6 (105 mg/m(2)). Hematotoxicity was mild, with only 1 @entity1 experiencing Grade 3 @entity1398 . @entity260 (30 days) occurred in 7 @entity1 , with an @entity834 rate of 22%. CONCLUSIONS: The recommended Phase II dose of @entity2600 in this setting is 90 mg/m(2)/week. Further Phase II exploration at this dose is warranted.

Preoperative hyperfractionated accelerated radiotherapy (HART) and concomitant XXXX in locally advanced @entity189 : a phase I study.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity2600 :: ('MESH:C051890', 'Chemical') :: ['CPT-11'] @entity834 :: ('MESH:D057868', 'Disease') :: ['anastomotic leak'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity189 :: ('MESH:D002277', 'Disease') :: ['rectal carcinoma'] @entity260 :: ('MESH:D011183', 'Disease') :: ['Postoperative complications'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia']
@entity2600 :: (MESH:C051890,Chemical) :: ['CPT-11']
