UNASSIGNED: 4098 Background: The combination of radiotherapy and chemotherapy is a mainstay for @entity5 . Improving local control could avoid mutilating salvage. We evaluate the role of an intensified strategy combining radio-chemotherapy with @entity1487 - @entity900 and cetuximab for locally advanced @entity5 in the setting of a multicentric phase II trial. METHODS: This study aimed to evaluate the response rate after radiotherapy and a concurrent @entity1487 - @entity900 regimen combined to cetuximab. @entity1 (pts) with locally advanced @entity5 treated by radiotherapy combined to @entity900 , @entity1487 and cetuximab. The primary end-point was local response rate 2 months after therapy. Secondary endpoints were progression-free survival, overall survival, colostomy-free survival and safety. A two-step design was used. RESULTS: Between 03/09 and 05/10, 16 @entity1 were included in 7 centers. All @entity1 presented locally advanced @entity5 (5 extended to the vagina, 1 to the bladder). All were @entity957 . Only 8 pts receive both the 6 cetuximab administrations and the two @entity1487 - @entity900 cycles. Accrual was suspended after 10 pts after the occurrence of 10 serious adverse events (SAE) in 7 @entity1 of which 6 SUSAR. The protocol was amended : decrease the @entity1487 and the @entity900 dose, mandatory IMRT. After accrual of 6 additional pts, 6 SAE in 5 pts. Severe @entity137 were: @entity2905 (8 pts), @entity294 (6 pts), fatigue (6 pts), @entity1398 (5 pts), @entity1910 (4 pts), @entity882 (4 pts), hypoNa or @entity3529 (4 pts); radioepithelitis 3 pts. 3 pts had severe @entity137 between 3-6 months follow-up: radio- @entity39 pelviperineal (1 pts); mucitis and @entity1910 (1 pts); @entity221 (1 pts). After exclusion of the 3 pts with early withdrawal and with a 14 months median follow-up, median PFS is 9 months and one-year survival rate 91%. (local failure (4 pts), @entity3 (1 pts). 4 @entity1 had colostomy (2 for local relapse, 2 for fistulisation). CONCLUSIONS: The IDMC decided to stop the trial after the first 16 @entity1 for a high rate of @entity137 and an insufficient efficacy. This regimen is not recommended combined with RT even in case of locally advanced disease.

Cetuximab plus radiochemotherapy in locally advanced XXXX : Interim results of the French multicenter phase II trial ACCORD16.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity3529 :: ('D011188', 'Chemical') :: ['K'] @entity1910 :: ('MESH:D005076', 'Disease') :: ['acneiform rash'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombopenia'] @entity5 :: ('MESH:D009369', 'Disease') :: ['anal cancer', 'tumors'] @entity2905 :: ('MESH:D008231', 'Disease') :: ['lymphopenia'] @entity957 :: ('MESH:D002294', 'Disease') :: ['squamous cell carcinoma'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatinum'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity39 :: ('MESH:D009336', 'Disease') :: ['necrosis'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity3 :: ('MESH:D009362', 'Disease') :: ['metastasis'] @entity221 :: ('MESH:D005334', 'Disease') :: ['febrile syndrome'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['5FU']
@entity5 :: (MESH:D009369,Disease) :: ['anal cancer']
