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

NCT06209099 | Recruiting

• 1 other identifier: PKUCH-R08
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Rectal Cancer

Keywords

organ preservation, chemoradiotherapy, neoadjuvant, rectal cancer, watch and wait

Outcome Measures

Primary Outcomes (1)

• Organ-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.

  Three years

Secondary Outcomes (3)

• Rate of non-regrowth disease-free survival (NR-DFS)

  Three years

• Stoma-free survival

  Three years

• Major adverse events

  Three years

Study Arms (3)

Group A: Nonoperative Management

EXPERIMENTAL

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

Procedure: Nonoperative Management (NOM)

Group B: Local Excision

EXPERIMENTAL

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;

Procedure: Local Excision (LE)

Group C: Total Mesorectal Excision

EXPERIMENTAL

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)

Procedure: Total Mesorectal Excision (TME)

Interventions

Nonoperative Management (NOM) PROCEDURE

Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Nonoperative Management (NOM)

Group A: Nonoperative Management

Local Excision (LE) PROCEDURE

Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Local Excision (LE)

Group B: Local Excision

Total Mesorectal Excision (TME) PROCEDURE

Drug: Oxaliplatin (OXA) Drug: Capecitabine (CAPE) Radiation: intensity modulated radiotherapy (IMRT) Behavioral: DRE-Endoscopy-MRI-CEA Procedure: Total Mesorectal Excision (TME)

Group C: Total Mesorectal Excision

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, Haidian District, 100142, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Central Study Contacts

Xiaokang Lei, M.D.

CONTACT

+8610-88196086; lxkpku@163.com

Lin Wang, M.D.

CONTACT

+8613910975011; wanglinmd@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Unit III & Ostomy Service, Gastrointestinal Cancer Center

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 17, 2024
• Study Start: January 17, 2024
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)