Organ preservation approach for low-risk rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of local excision (LE) or non-operative management (NOM) in patients with MRI-defined low-risk rectal cancer after receiving neoadjuvant intensity-modulated radiotherapy combined with capecitabine and consolidation CapeOX. The study will assess the organ-preservation rate and determine whether LE or NOM is a viable treatment option for these patients. Participants will be assigned to radical surgery, LE, or NOM based on their response to the initial treatment. The trial focuses on patients who meet specific MRI criteria for low-risk rectal cancer.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Cancer Hospital & Institute
  Beijing, Haidian District, China Recruiting

Study contacts

• Study coordinator: Xiaokang Lei, M.D.
• Email: lxkpku@163.com
• Phone: +8610-88196086

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.