Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer

Peking University Cancer Hospital & Institute

Status: Enrolling

Conditions: Rectal Cancer

Treatments: Procedure: Local Excision (LE); Procedure: Total Mesorectal Excision (TME); Procedure: Nonoperative Management (NOM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06209099

PKUCH-R08

Details and patient eligibility

About

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.

Enrollment: 67 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years and ≤85 years
• ECOG Performance status 0-1
• Histologically confirmed diagnosis of adenocarcinoma of the rectum, with tumor differentiation Grade 1-3
• The distance from down verge of tumor to anal-rectal junction (ARJ) ≤4cm based on MRI, or ≤8 cm based on sigmoidoscopy
• Clinical Stage T2 or T3a or T3b and EMVI (-) and MRF (-) and extra-mesorectal metastatic lymph node (-) based on MRI
• The maximum diameter of the tumor is ≤4cm or the circumferential invasion range is less than 1/3 of the intestinal circumference
• No evidence of distant metastases
• No prior pelvic radiation therapy
• No prior chemotherapy or surgery for rectal cancer
• No active infections requiring systemic antibiotic treatment
• ANC > 1.5 cells/mm3, HGB > 10.0 g/dL, PLT > 100,000/mm3, total bilirubin ≤ 1.5 x ULN, AST≤ 3 x ULN, ALT ≤ 4 x ULN
• Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.

Exclusion criteria

• Recurrent rectal cancer
• Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en-bloc resection will not achieve negative margins
• Creatinine level greater than 1.5 times the upper limit of normal
• Patients who have received prior pelvic radiotherapy
• Patients who are unable to undergo an MRI
• Patients with a history of a prior malignancy within the past 5 years, except for well treated basal cell cancer, squamous cell skin cancer, breast cancer, thyroid cancer or small renal cancer, and with DFS >5 years
• Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA
• Other anticancer or experimental therapy
• Women who are pregnant or breast-feeding
• Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 3 patient groups

Group A: Nonoperative Management

Experimental group

Description:

Patients who achieve Clinical complete response (cCR) or near-cCR when restaged at 16 weeks following IMRT plus consolidation CapeOX.

Treatment:

Procedure: Nonoperative Management (NOM)

Group B: Local Excision

Experimental group

Description:

Patients with near-cCR or residual tumor ≤ycT2N0 when reassessed at 16 weeks following IMRT plus consolidation CapeOX; or Patients with regrowth ≤ycT2N0 when reassessed during surveillance in NOM;

Treatment:

Procedure: Local Excision (LE)

Group C: Total Mesorectal Excision

Experimental group

Description:

Patients with residual tumor >ycT2N0 when restaged at 16 weeks following IMRT plus consolidation CapeOX. or Patients with regrowth >ycT2N0 when reassessed during surveillance in NOM; or Patients with any high-risk pathological factors following local excision (LE)

Treatment:

Procedure: Total Mesorectal Excision (TME)