Chemoradiotherapy and consolidation chemotherapy for lower rectal cancer

Phase 2

Recruiting

• Conditions: Rectal cancer; Lower rectal cancer; Rectal Neoplasms

• Registration Number: JPRN-jRCTs021190023
• Lead Sponsor: Miura Takuya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1) Histologically confirmed rectal adenocarcinoma
2) Tumor lower margin is located at lower rectum or anal canal (Rb or P) and palpable by digital examination
3) High resolution MRI examination is possible and the risk factor of recurrence is noted
greater than 5mm spread from mucularis propria, lymph node metastasis, positive EMVI, positive CRM, positive intersphincteric plane
4) No distant metastases
5) Eastern Cooperative Oncology Group performance status (PS) 0-1
6) Aged 20 years and older
7) Adequate hematological, hepatic, renal and metabolic function parameters
8) Written informed concent

Exclusion Criteria

1) Tumor lower margin is located at middle rectum (Ra) and not palpable by digital examination
2) Tumor invading surrounding organs
3) Lateral lymph node metastasis (Diameter of short axis is equal to or greater than 5mm)
4) Distant metastasis
5) MRI contraindications (Pace maker, cerebral artery clipping etc.)
6) Myelosuppresion (neutrophil count < 1,500/mm3, platlet count < 100,000/mm3)
7) Serious renal dysfunction (Creatinine Clearance < 30mL/min)
8) History of chemotherapy fot rectal cancer
9) History of radiotheraphy to the pelvic region
10) Known allergic reactions on study medication
11) Major surgery within the last 4 weeks prior to enrolment
12) Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, congestive heart failure, brain stroke, pulmonary embolism, etc.) within the last 6 months before enrolment
13) Serious concurrent diseases (incl. Interstitial pneumoniae, pulmonary fibrosis, severe liver function disorders, active and uncontrolled infections, etc.)
14) Pregnant or lactating women, women who are capable of pregnancy and intend to get pregnant or men who want to get their partners pregnant
15) Physician will determine that the patient is inappropriate participate in this trail for the safety.

Study & Design

• Study Type: Interventional
• Study Design: Not specified