Preoperative Chemoradiation Followed by Chemotherapy for Locally Advanced Rectal Cancer

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The current standard treatment of locally advanced rectal cancer (clinical stage II or III) is preoperative radiation with chemotherapy (CRT) followed by surgery. But this approach can be suboptimal for patients with high risk features (more deeply-seated tumor or many regional lymph nodes involved)that are associated with recurrence. This study test a hypothesis that CRT followed by chemotherapy before surgery can improve efficacy of preoperative treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Collaborator: Korean Cancer Study Group
• Treatments: Capecitabine; Fluorouracil; Oxaliplatin

Criteria

Inclusion Criteria:

• histologically confirmed adenocarcinoma of the rectum

• distal margin of tumor located from 0 to 12 cm from anal verge measured by digital rectal examination

• high risk clinical stage II or III in MRI (satisfying at least one of the followings)

• circumferential resection margin < 1 mm involved

• low-lying tumor below anal verge 3 cm

• T3 > 5 mm extramural spread

• T4 (involving surrounding structures or peritoneum)

• cN2 (4 or more mixed signal intensity or irregularly bordered node or tumor deposit)

• age 20 years or more

• ECOG (Eastern Cooperative Oncology Group) performance status 0-2

• No prior chemotherapy, radiotherapy to pelvis

• Adequate bone marrow function

• Adequate renal function

• Adequate hepatic function

• patients must sign the informed consent indicating that they were aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

• malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease

• any unresected synchronous colon cancer

• any distant metastases

• intestinal obstruction or impending obstruction, but decompressing colostomy is permitted

• any previous or concurrent malignancy withih 5 years other than non-melanoma skin cancer / in situ cancer of uterine cervix / early gastric cancer / thyroid cancer of low risk

• any other morbidity or situation with relative contraindication for chemoradiotherapy

• patients with history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine

• pregnant or lactating women or patients of childbearing potential not predicting adequate contraception