Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer

• Status: Unknown status
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators compare two-week course of chemoradiation (33 Gy in 10 fractions with oral capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and leucovorin) in this randomized trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jong Hoon Lee; Seoul St. Mary's Hospital
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

1. histologically confirmed adenocarcinoma;

2. distal margin of the tumor located < 10 cm from the anal verge;

3. cT3-4N0-2 classification as determined by magnetic resonance imaging (MRI) and/or endorectal ultrasonography (EUS);

4. no evidence of distant metastasis;

5. Karnofsky performance score over 70;

6. adequate bone marrow, liver, and renal function (leucocytes >4000/mm3, hemoglobin >10 g/dL, platelets >100,000/mm3; serum bilirubin <1.5 mg/dL, serum transaminase <2.5 times the upper normal limit; serum creatinine <1.5 mg/dL).

Exclusion Criteria:

1. Metastatic disease

2. No complete resection of tumor (R2)