NCT01952951

Preoperative Chemoradiation Followed by Chemotherapy for Locally Advanced Rectal Cancer

A Randomized Phase II Trial of Preoperative Chemoradiation (Preop CRT) Followed by CapOx (Capecitabine Plus Oxaliplatin) Versus Preop CRT Alone for Locally Advanced Rectal Cancer (LARC)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Downstaging rate with CRT using fluoropyrimidine monotherapy is usually 30-40%.In MRI-defined high-risk patients, downstaging rate with conventional fluoropyrimidine-based monotherapy with radiation has not been shown. We assume that the downstaging rate of chemoradiation arm (control arm) would be 30%, and that addition of CapOx after CRT (experimental arm) may increase downstaging rate 30% to 50%. A sample size of 52 patients per group is needed have 85% power to detect downstaging rate = 50% as compared to 30% with type I error rate of 15%. We will perform one interim futility analysis when half of the patients are recruited and evaluated for the primary endpoint. O'Brien-Fleming boundary will be considered. Therefore, when 26 patients per arm are evaluated, the interim futility analysis will be performed, and when the Z score at the interim is less than -0.09192 (one-sided p-value greater than 0.5366192), the study will be stopped for futility. Considering 5% follow-up loss, a sample size of 55 per arm (a total of 110 patients) will be studied.

Conditions

• Rectal Neoplasms
• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Capecitabine Oxaliplatin	after completion of chemoradiation, two cycles of capecitabine (850mg/m2 twice daily from D1 evening to D15 morning) and oxaliplatin (100mg/m2 on D1) will be administered every 3 weeks.
RADIATION	pelvic radiation capecitabine 5-fluorouracil	50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-09-01
• Completion: 2019-12-01
• First posted: 2013-09-30
• Last updated: 2017-09-13

Locations

7 sites across 1 country: South Korea