OMINATE trial

Phase 2

Recruiting

• Conditions: rectal cancer

• Registration Number: JPRN-jRCTs051200121
• Lead Sponsor: Akiyoshi Takashi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

1) Histologically confirmed diagnosis of adenocarcinoma of the rectum
2) <= 5 cm from the anal verge or candidate for APR or intersphincteric resection prior to neoadjuvant therapy according to the primary surgeon
3) Clinical stage II (cT3-4N0) or stage III (cT3-4N1-3) by MRI and CT (cohort1)
Clinical stage cT2NanyM0 by MRI and CT (cohort2)
4) ECOG PS 0 or 1
5) Age >= 20 years
6) Adequate organ functions within 28 days prior to entry
i. Neutrophils >= 1,500 /mm3
ii. Platelets >= 10*104 /mm3
iii. Hemoglobin >= 9.0 g/dL
iv. Total bilirubin <= 2.0 mg/dL
v. AST, ALT <= 100 IU/L
vi. Serum creatinine <= 1.5 mg/dL or Ccr >= 60 mL/min/body
vii. Urine protein/creatinine < 1
7) If there is bowel obstruction or strong stricture, stoma construction prior to neoadjuvant therapy
8) Written informed consent

Exclusion Criteria

1) Patients with a history of a prior malignancy within the past 5 years, except for adequately treated cancer with 5-year relative survival rate >= 95%
2) History of pelvic irradiation
3) Administration contraindication of capecitabine, oxaliplatin, or bevacizumab
4) Uncontrolled active infection
5) Fever 38.0 >= degree celsius at entry
6) Possible pregnant or pregnant or nursing female
7) Patients with concurrent psychiatric condition or disease which would make them inappropriate candidates for entry into this study in the investigator's judgement
8) Patients with concurrent serious complication (heart failure, interstitial lung disease or pulmonary fibrosis, uncontrolled diabetes, renal failure, liver failure, hypertension, thrombotic disease, gastrointestinal fistula, etc)
9) History of operation <= 4 weeks or minor operation such as stoma construction <= 2 weeks
10) Deficient mismatch repair (dMMR) determined by immunohistochemistry and/or MSI testing using pre-treatment biopsy specimens
11) Other conditions not suitable for this study in the investigator's judgement

Study & Design

• Study Type: Interventional
• Study Design: Not specified