Non-surgical treatment for low rectal cancer after chemotherapy and radiation

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 study evaluates the safety of non-operative management (NOM) for patients with low rectal cancer who achieve a complete clinical response after chemoradiotherapy. It aims to determine if NOM can effectively replace surgery by monitoring local re-growth rates and the presence of positive resection margins when surgery is necessary. The study will involve active surveillance of patients instead of immediate surgical intervention, potentially reducing the long-term complications associated with surgery. Conducted across multiple centers in Canada, this Phase II trial seeks to provide more robust evidence for the NOM approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Completed chemoradiotherapy (CRT) as standard of care \[Stage II and Stage III (T3-T4N0, AnyTN1-2)\]; \[50 Gy (2 Gy x 25 fractions) with 5-FU or capecitabine\]
* Planned or probable APR
* ALL criteria for complete clinical response are met between 8 and 10 weeks following completion of CRT
* 18 years or older
* Provides written consent

Exclusion Criteria:

* Unable to undergo MRI
* Metastatic disease (including extramesorectal and retroperitoneal lymph nodes)
* Pregnancy
* Inflammatory bowel disease
* More than one primary colorectal cancer
* Other malignancy within 5 years of treatment for current rectal cancer
* Unfit for surgery

Where it's running

• Sinai Health System
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Erin Kennedy — Sinai Health System
• Study coordinator: Erin Kennedy
• Email: erin.kennedy@sinaihealthsystem.ca
• Phone: 416-586-4800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Characterization of the tumor microenvironment in locally advanced rectal cancer before and during neoadjuvant therapy

  This observational study tests how the tumor and immune cells change in locally advanced rectal cancer from baseline to during neoadjuvant therapy using advanced genomic and immune profiling.

  Recruiting Fujian Medical University Union Hospital · Fuzhou, Fujian · NCT07920770

• Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX

  This study tests whether adding fruquintinib to short-course radiotherapy plus tislelizumab and CAPOX before surgery helps people with locally advanced low rectal cancer achieve a better tumor response.

  Recruiting Phase 2 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07888309

• Gut and tumor bacteria patterns in metastatic versus non-metastatic colorectal cancer

  This project will test whether bacteria in the gut and tumor differ between people whose colorectal cancer has spread and those whose cancer has not to see if bacterial signatures can help predict spread.

  Recruiting Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT07154173

• Comparing two surgical techniques for anal function after low rectal cancer surgery

  This study is testing which of two surgical methods helps people with ultra-low rectal cancer have better bowel control and quality of life after surgery.

  Recruiting Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT05943444

• Comparing treatment options for mid-low rectal cancer

  This study is testing different treatment options for mid-low rectal cancer to see which ones work best and are most cost-effective for patients and healthcare providers in China.

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT05871762

• Platform program for evaluating treatments in metastatic HER2-positive breast cancer

  This study is testing different new treatments for people with advanced HER2-positive breast cancer to see which ones work best before moving them to larger trials.

  Recruiting at 5 sites Phase 1/2 QuantumLeap Healthcare Collaborative · Birmingham, Alabama and 9 other locations · NCT05868226

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.