The goal of this clinical trial is to test the safety and efficacy of local excision (LE) or non-operative management (NOM) in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX. The main questions it aims to answer are: 1. What is the organ-preservation rate (OPR) after in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX? 2. Is LE or NOM safe and effective in patients with MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX? Participants will receive radical surgery, LE, or NOM based on the response of neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX in patients with MRI defined low-risk rectal cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Nonoperative Management (NOM)
Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Local Excision (LE)
Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Total Mesorectal Excision (TME)
Peking University Cancer Hospital & Institute
Beijing, Haidian District, China
RECRUITINGOrgan-preservation rate
The rate of organ preservation will be defined as the percentage of patients who achieve cCR or near-cCR after neoadjuvant treatment followed by local excision or non-operative management (NOM). The time of organ preservation will be measured from the initiation of treatment.
Time frame: Three years
Rate of non-regrowth disease-free survival (NR-DFS)
NR-DFS will be defined as the length of time after treatment until death (any cause), tumor relapse including local pelvic recurrence following TME or local resection and any distant metastasis during or after treatment. Surgical salvageable local regrowth occurs in non-operative management will not be defined as tumor relapse.
Time frame: Three years
Stoma-free survival
Stoma-free survival will be defined as the length of time in which patients live with a temporary or permanent stoma and be measured from the initiation of treatment. Events for stoma-free survival are temporary or permanent stoma or death (any cause). Temporary ileostomy-free survival or colostomy-free survival will also be calculated.
Time frame: Three years
Major adverse events
Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Time frame: Three years
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