NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051190049

Registered date:11/09/2019

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)

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedColorectal cancer
Date of first enrollment25/09/2019
Target sample size80
Countries of recruitment
Study typeInterventional
Intervention(s)Capecitabine administered as adjuvant chemotherapy. Group A: capecitabine (2500 mg/m2/day) is taken for five days followed by two days of rest. One course lasts three weeks, and eight courses (24 weeks) are administered. Group B: capecitabine (2500 mg/m2/day) is taken on 14 consecutive days followed by seven days of rest. One course lasts three weeks, and eight courses (24 weeks) are administered.

Outcome(s)

Primary OutcomeTreatment completion rate, feasibility
Secondary OutcomeRelative dose strength Relative dose intensity, quality of Life, adverse events rate, recurrence-free survival

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
GenderBoth
Include 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.
Exclude 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.

Related Information

Contact

Public contact
Name Shozo Yokoyama
Address 27-1 Takinai-cho,Tanabe-shi, Wakayama, Japan Wakayama Japan 646-8558
Telephone +81-739-26-7050
E-mail yokoyama@wakayama-med.ac.jp
Affiliation National Hospital Organization Minami Wakayama Medical Center
Scientific contact
Name Shozo Yokoyama
Address 27-1 Takinai-cho,Tanabe-shi, Wakayama, Japan Wakayama Japan 646-8558
Telephone +81-739-26-7050
E-mail yokoyama@wakayama-med.ac.jp
Affiliation National Hospital Organization Minami Wakayama Medical Center