Low-dose capecitabine adjuvant chemotherapy in elderly stage II-III colorectal cancer patients LC-ACEC: study protocol for a randomized controlled trialReportar como inadecuado




Low-dose capecitabine adjuvant chemotherapy in elderly stage II-III colorectal cancer patients LC-ACEC: study protocol for a randomized controlled trial - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 16:238

First Online: 29 May 2015Received: 15 January 2015Accepted: 12 May 2015DOI: 10.1186-s13063-015-0753-7

Cite this article as: He, Y., Liu, P., Zhang, Y. et al. Trials 2015 16: 238. doi:10.1186-s13063-015-0753-7

Abstract

BackgroundOver half of the patients were diagnosed with colorectal cancer after 70 years of age. The choice of the most suitable chemotherapy strategy is the major challenge for elderly patients. Previous trials indicated that elderly patients with stage II-III colorectal cancer obtained no significant benefits from oxaliplatin-based adjuvant chemotherapy. Therefore, single-agent oral capecitabine is regarded as an effective alternative with retained efficacy and improved flexibility. However, the optimal dose of capecitabine for elderly patients remains controversial. Recent studies have adopted a low-dose strategy 1,000 mg-m for elderly patients, but the long-term efficacy of this strategy has not been identified so far. Thus, we designed this trial to investigate non-inferiority of the lower-dose strategy of capecitabine compared with the approved-dose strategy for adjuvant chemotherapy of elderly patients with stage II-III colorectal cancer.

MethodsLC-ACEC Low-dose Capecitabine Adjuvant Chemotherapy for Elderly Patients With Stage II-III Colorectal Cancer is a prospective, randomized, open-label, non-inferiority phase III clinical trial including 926 eligible patients. Patients will be randomly assigned to receive a capecitabine adjuvant chemotherapy strategy of lower dose 1,000 mg-m twice daily on days 1 to 14 of every 21 days or approved dose 1,250 mg-m twice daily on days 1 to 14 of every 21 days. The primary outcome is 3-year disease-free survival. Secondary outcomes include 3-year overall survival, toxic and side effects during treatment, completion rate, and quality of life.

DiscussionThis is the first randomized trial to evaluate the efficacy and safety of a low-dose strategy of capecitabine in adjuvant chemotherapy of elderly patients with stage II-III colorectal cancer, and the results are believed to provide new evidence on the treatment of elderly patients with colorectal cancer.

Trial registrationClinicalTrials.gov identifier NCT02316535 Dec. 12, 2014.

KeywordsElderly Colorectal cancer Adjuvant chemotherapy Capecitabine Low-dose Non-inferiority Randomized controlled trial AbbreviationsACCENTAdjuvant Colon Cancer Endpoints

AEAdverse event

AVEXbevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer

bidtwice a day bis in die

CIconfidence interval

CRCcolorectal cancer

CRFcase report form

CTcomputed tomography

DFSdisease-free survival

DSMBdata and safety monitoring board

ECOGEastern Cooperative Oncology Group

Fufluorouracil

HRhazard ratio

LC-ACECLow-dose Capecitabine Adjuvant Chemotherapy for Elderly Patients With Stage II-III Colorectal Cancer

Lvleucovorin

NCI-CTCNational Cancer Institute Common Toxicity Criteria

PSperformance status

QoLquality of life

RCTradiochemotherapy

SAEsevere adverse event

X-ACTXeloda in Adjuvant Colon Cancer Therapy

WCHWest China Hospital

Yazhou He and Ping Liu contributed equally to this work.

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Autor: Yazhou He - Ping Liu - Yuanchuan Zhang - Xiangbing Deng - Wenjian Meng - Mingtian Wei - Tinghan Yang - Ziqiang Wang - Meng

Fuente: https://link.springer.com/







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