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Low-dose Capecitabine Adjuvant Chemotherapy for Elderly Patients With Stage II/III Colorectal Cancer (LcACEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02316535
Recruitment Status : Unknown
Verified September 2016 by Ziqiang Wang,MD, West China Hospital.
Recruitment status was:  Recruiting
First Posted : December 15, 2014
Last Update Posted : September 13, 2016
Information provided by (Responsible Party):
Ziqiang Wang,MD, West China Hospital

Brief Summary:
Approximately half of colorectal cancer (CRC) patients were first diagnosed after 70 years old. However, compared with younger patients, elderly patients were often undertreated in chemotherapy due to their impaired tolerance. Recently, there have been great controversy on adjuvant chemotherapy strategy for stage II/III CRC patients. As an oral fluoropyrimidine, capecitabine has been demonstrated to be equivalent to i.v. 5-Fu/leucovorin regimen in stage III CRC patients. In light of fewer adverse effects and better flexibility, capecitabine was regarded as an ideal alternative for elderly CRC patients, but the optimal dosage for stage II/III elderly CRC patients still remains inconclusive. Our trial expected to prospectively randomized 710 postoperative stage II/III elderly CRC patients (between 70 and 90 years of age) to adjuvant mono-chemotherapy with a standard dose of capecitabine (2500 mg/m2/day) or a reduced dose (2000 mg/m2/day). This is a non-inferiority phase 3 trial with a primary endpoint of 3-year disease free survival (DFS), and other outcomes include 3-year overall survival(OS), completion rate, toxic and adverse effects and quality of life(Qol). By this trial, we aimed to achieve more precise evidence on the individualized adjuvant chemotherapy strategy for stage II/III elderly CRC patients.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Capecitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 710 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low-dose Versus Standard-dose Capecitabine Adjuvant Chemotherapy for Chinese Elderly Patients With Stage II/III Colorectal Cancer: A Randomized, Phase 3 Non-inferiority Study
Study Start Date : November 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: standard-dose
capecitabine, oral administration, 1,250 mg/m2 twice daily on days 1-14, and repeated on day 22; 8 circles in total.
Drug: Capecitabine
adjuvant chemotherapy;
Other Name: Xeloda

Experimental: reduced-dose
capecitabine, oral administration, 1,000 mg/m2 twice daily on days 1-14, and repeated on day 22; 8 circles in total.
Drug: Capecitabine
adjuvant chemotherapy;
Other Name: Xeloda

Primary Outcome Measures :
  1. disease free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 3 years ]
  2. toxic and adverse effects [ Time Frame: 30 weeks ]
  3. completion rate [ Time Frame: 24 weeks ]
  4. quality of life [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. With informed consents
  2. Histologically identified carcinoma of colon and rectum
  3. pT3-4NanyM0 or pTanyN+M0(stage II/III)
  4. age between 70 to 90
  5. undergone R0 resection
  6. ECOG ≤2
  7. Stage II patients with microsatellite stable (MSS) or microsatellite low (MSL)

Exclusion Criteria:

  1. With other types of malignances simultaneously
  2. Creatinine clearance ≤ 70 ml/min
  3. Undergone neoadjuvant chemotherapy
  4. In anticoagulant therapy
  5. Pregnant or lactating women
  6. History of antineoplastic drugs
  7. With other contraindications for chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02316535

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Contact: Yazhou He, MD +8615196636081
Contact: Xiangbing Deng, MD +8613730677124

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China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610000
Contact: Ziqiang Wang, MD/PhD    +86-18980602028   
Contact: Yazhou He, MD    +86-15196636081   
Sponsors and Collaborators
West China Hospital
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Principal Investigator: Ziqiang Wang, MD/PhD West China Hospital
Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ziqiang Wang,MD, Professor, West China Hospital Identifier: NCT02316535    
Other Study ID Numbers: LcACEC-201474
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Keywords provided by Ziqiang Wang,MD, West China Hospital:
colorectal cancer
stage II/III
adjuvant chemotherapy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents