Randomized controlled trial of capecitabine comparing 5-days-on/2-days-off regimen with 2-weeks-on/1-week-off regimen as adjuvant chemotherapy for colorectal cancer(RCT of capecitabine 5-days-on/2-days-off or 2-weeks-on/1-week-off regimen for colorectal cancer)

Phase 2

• Conditions: Colorectal cancer

• Registration Number: JPRN-jRCTs051190049
• Lead Sponsor: Yokoyama Shozo

Brief Summary

Although there was no significant difference, the capecitabine 5-day-on/2-day-off regimen group showed a higher percentage of completion. In terms of relative dose intensity and quality of life, the capecitabine 5-day-on/2-day-off regimen was considered an acceptable regimen compared to the regular-administration (2-weeks-on/1-week-off regimen).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-11
• Study Completion: 2023-07-31
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

(1) Curatively resected case of primary colorectal adenocarcinoma according to histopathology.
(2) Postoperative adjuvant chemotherapy for stage II (high risk) and stage III colorectal cancer.
In stage II (high risk) cases, sampling of less than 12 lymph nodes, T4 stage, clinical presentation with perforation, poorly differentiated adenocarcinoma, signet ring cell carcinoma, mucinous carcinoma, vascular or lymphatic or perineural invasion, clinical presentation with intestinal occlusion.
(3) Aged 20 - 80 years (date of registration).
(4) Performance status 0 or 1.
(5) No significant damage to major organs (bone marrow, heart, lungs, liver, kidneys, etc.)
(6) The criteria below are satisfied within 28 days before registration. When there are various test results within the relevant period, the closest to the registration will be adopted. Blood transfusion or administration of a hematopoietic factor preparation will not be performed within two weeks before the test.
i) WBC >= 3000/mm3
ii) Neutrophil >= 1,500/mm3
iii) PLT >= 100000/mm3
iv)Hb >= 9.0 g/dL
v) T-Bil <= 1.5 mg/dL
vi) AST, ALT <= 100 IU/L
vii) Cr <= 1.5 mg/dL
(7) Written informed consent before registration.

Exclusion Criteria

(1) Active co-existing malignancy (synchronous or metachronous malignancy with disease-free period within 1 year) Carcinoma in situ and mucosal carcinoma lesions treated with appropriate endoscopic treatment can be registered.
(2) History of severe drug hypersensitivity.
(3) Cases in which enrollment to this study is judged to be difficult due to mental or neurological diseases that could affect results.
(4) Any of the conditions below. (Imaging test, blood sampling and definitive diagnosis are conducted if there is suspicion of these complications at registration.)
i) Uncontrolled diabetes mellitus.
ii) Uncontrolled hypertension.
iii)Interstitial pneumonia or pulmonary fibrosis.
iv)Intestinal paralysis or obstruction.
v) Heart problems that cause clinical problems.
(5) Already received other chemotherapy after surgery.
(6) Temporary ileostomy or colostomy closure is scheduled after surgery and the 24-week continuous administration period is interrupted for an extended time.
(7) History of hypersensitivity to components of this drug or fluorouracil.
(8) Pregnancy, possible pregnancy, and nursing mothers.
(9) Judged to be otherwise unsuitable for safe inclusion this study by a physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified