PURPOSE: To perform a prospective, multi-institutional, phase 2 study of a substantial decrease in concurrent chemoradiation therapy (CRT) intensity as primary treatment for favorable-risk, @entity1082 -associated @entity957 . METHODS AND MATERIALS: The major inclusion criteria were: (1) T0 to T3, N0 to N2c, M0; (2) @entity1082 or p16 positive; and (3) minimal/remote smoking history. Treatment was limited to 60 Gy intensity modulated radiation therapy with concurrent weekly intravenous @entity900 (30 mg/m(2)). The primary study endpoint was pathologic complete response (pCR) rate based on required biopsy of the primary site and dissection of pretreatment positive lymph node regions, regardless of radiographic response. Power computations were performed for the null hypothesis that the pCR rate is 87% and n=40, resulting in a type 1 error of 14.2%. Secondary endpoint measures included physician-reported @entity137 (Common @entity137 Terminology for Adverse Events, CTCAE), @entity1 -reported symptoms (PRO-CTCAE), and modified barium swallow studies. RESULTS: The study population was 43 @entity1 . The pCR rate was 86% (37 of 43). The incidence of CTCAE grade 3/4 @entity137 and PRO-CTCAE severe/very severe symptoms was as follows: @entity33 34%/45%, general @entity158 5%/48%, @entity390 18%/52%, vomiting 5%/34%, @entity1282 39%/55%, and @entity2133 2%/75%. Grade 3/4 hematologic @entity137 were 11%. Thirty-nine percent of @entity1 required a feeding tube for a median of 15 weeks (range, 5-22 weeks). There were no significant differences in modified barium swallow studies before and after CRT. CONCLUSIONS: The pCR rate with decreased intensity of therapy with 60 Gy of IMRT and weekly low-dose @entity900 is very high in favorable-risk @entity957 , with evidence of decreased @entity137 compared with standard therapies. ClinicalTrials.gov ID: NCT01530997.

Phase 2 Trial of De-intensified Chemoradiation Therapy for Favorable-Risk XXXX -Associated @entity957 .

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'Toxicity', 'toxicities'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity2133 :: ('MESH:D014987', 'Disease') :: ['xerostomia'] @entity957 :: ('MESH:D002294', 'Disease') :: ['oropharyngeal squamous cell carcinoma'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatinum'] @entity33 :: ('MESH:D052016', 'Disease') :: ['mucositis'] @entity1082 :: ('10566', 'Species') :: ['human papillomavirus'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity1282 :: ('MESH:D003680', 'Disease') :: ['dysphagia']
@entity1082 :: (10566,Species) :: ['Human Papillomavirus']
