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

NCT02316535 | Unknown Phase 3 DMC

• 1 other identifier: LcACEC-201474
• Study Type: interventional
• Target: 710
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Keywords

colorectal cancer; stage II/III; elderly; adjuvant chemotherapy; capecitabine; non-inferiority

Outcome Measures

Primary Outcomes (1)

• disease free survival

  3 years

Secondary Outcomes (4)

• overall survival

  3 years

• toxic and adverse effects

  30 weeks

• completion rate

  24 weeks

• quality of life

  3 years

Study Arms (2)

standard-dose

ACTIVE COMPARATOR

capecitabine, oral administration, 1,250 mg/m2 twice daily on days 1-14, and repeated on day 22; 8 circles in total.

Drug: Capecitabine

reduced-dose

EXPERIMENTAL

capecitabine, oral administration, 1,000 mg/m2 twice daily on days 1-14, and repeated on day 22; 8 circles in total.

Drug: Capecitabine

Interventions

Capecitabine DRUG

adjuvant chemotherapy;

Also known as: Xeloda

reduced-dose; standard-dose

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• With other types of malignances simultaneously
• Creatinine clearance ≤ 70 ml/min
• Undergone neoadjuvant chemotherapy
• In anticoagulant therapy
• Pregnant or lactating women
• History of antineoplastic drugs
• With other contraindications for chemotherapy

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

Related Publications (14)

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  PMID: 26021722 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ziqiang Wang, MD/PhD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yazhou He, MD

CONTACT

+8615196636081; yazhou_he@foxmail.com

Xiangbing Deng, MD

CONTACT

+8613730677124; xiangbingdeng@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 15, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: September 13, 2016

Record last verified: 2016-09

Locations

CN (1)