NCT02860234

Tailored Operative or Non-operative Management for Low-risk Rectal Cancer After Intensive Neoadjuvant Treatment

Tailored Operative or Non-operative Management for MRI Defined Low-risk Rectal Cancer Following Neoadjuvant Intensity Modulated Radiotherapy With Concurrent Capecitabine Plus Consolidation CapeOX.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 68 (actual)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to test the efficacy of tailored operative or non-operative management (NOM) for MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX. The main purpose of this study is to increase organ-preservation rate for low-risk rectal cancer patients.

Detailed description

Neoadjuvant chemoradiotherapy (nCRT), total mesorectal excision and adjuvant chemotherapy comprise the standard treatment for locally advanced rectal cancer, following which 15-30% patients achieved pathological complete response need to receive the removal of rectum without residual tumor and suffer significant functional impairment even after sphincter preservation. Adjuvant chemotherapy is also questioned for its benefit for prolonged survival through the data from various studies. More evidence demonstrated that organ-preservation (e.g. non-operative management or local excision) for patients with clinical complete response (cCR) or near-cCR following nCRT had similar survival when compared with those received standard care. This study is designed to investigate the efficacy of neoadjuvant intensity modulated nCRT with concurrent capecitabine plus consolidation CapeOX for T2/DWI/Enhanced MRI defined cT2-T3b mid-low rectal cancer without threatening mesorectal fascia or extramural vascular invasion (EMVI) or mrN2 disease. According to the response to treatment evaluated by multi-modal assessment including digital exam, T2/DWI/Enhanced MRI, endoscopy and serum CEA test, patients will receive tailored operative management like local excision or total mesorectal excision, or non-operative management. Intention to treatment was also allowed in this study. Firstly, the investigators will observe the organ preservation rate at 2 years. Endpoints for organ-preservation like non-regrowth DFS, stoma-free survival and other conventional survival outcomes (DFS, OS) would be further collected. The short-term and long-term QoL will be measured in all patients. . Our baseline data showed the 48% of locally advanced rectal cancers could be downstaged to stage ypT0-2N0 following IMRT with concurrent capecitabine. We hypothesize that at least 24% of rectal cancers could be candidates for LE or NOM after IMRT and the rectum preservation rate will increase to 40% in low-risk rectal cancers by LE or NOM following IMRT plus consolidation CapeOX at 2 years. As a superiority design, this study need to recruit 64 patients to test this hypothesis, with 85% power (exact binomial test for proportions, alpha = 5 %, one-sided), If the number of responses is 22 or more, the hypothesis that P \<= 0.240 is rejected. We anticipate about 10 % loss to follow-up, so we will recruit an additional 8 patients and the study will recruit 72 patients in all.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin
DRUG	Capecitabine
RADIATION	intensity modulated radiotherapy
PROCEDURE	DRE-Endoscopy-MRI-CEA
PROCEDURE	Nonoperative Management
PROCEDURE	Local Excision
PROCEDURE	Total Mesorectal Excision
BEHAVIORAL	Quality of Life Questionnaires

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2016-08-09
• Last updated: 2021-07-23

Locations

1 site across 1 country: China