Comprehensive Management of Rectal Cancer (CMRC)

study on the strategy we have adopted for rectal cancer treated with chemoradiotherapy in the case of a complete reponse ( surveillance vs. surgery) Particular Case of Patients with Complete Response After CRT. Traditionally, for patients with mid or lower rectal cancer, a protocol involving chemoradiotherapy followed by surgery 8 to 10 weeks after the end of radiotherapy and chemotherapy is systematically indicated after a post-chemoradiotherapy reassessment using pelvic MRI.

In a certain number of patients (25%), it was noted that the reevaluation through pelvic MRI after chemoradiotherapy shows complete tumor disappearance.

However, these patients were still operated on according to the standard procedure, and pathologists found no tumor in the surgical specimen (sterile specimen).

These are patients with a complete radiological and pathological response. In such cases, it is possible to resect the scar that remains at the site of the tumor (radiotherapy sequelae) and closely monitor the patient to detect recurrence in the short and medium term, thus avoiding mutilating surgery that impacts quality of life (fecal and gas incontinence, increased bowel movements, urinary and gynecological sexual disorders). This is known as the "Watch and Wait" strategy.

"Watch and Wait" Strategy. An initial opportunistic approach, also called Watch and Wait (W&W), involves monitoring patients who are considered to have a complete response after CRT or total neoadjuvant treatment, regardless of the initial stage. This approach was developed by Habr-Gama et al. in Brazil and published in 18 different articles, involving a cohort of 361 patients, with complete response rates ranging from 20% to 30%. Local recurrence rates varied from 5% to 25% depending on the articles and the timing of complete clinical response evaluation, while maintaining a 5-year disease-free survival rate of 52% and an overall survival rate of 85%. These series primarily included cT2 or cT3 tumors, but also cT4 tumors. Complete clinical response was defined as the absence of any clinical tumor residue (no tumor, no ulcer, and negative biopsy), and patients were monitored monthly.

However, the evaluation timeline for complete response varied across the articles, ranging from 8 weeks to 14 months.

At present, no official recommendations validate this strategy; it remains an expert opinion. The aim is to demonstrate that we could avoid surgery in patients with a complete response (we have favored rectal surgery for the majority of our patients due to organizational obstacles, patient-related issues, and the difficulty in applying rigorous surveillance in certain cases).

The purpose of this research is to improve our practices in managing rectal cancer in patients with a complete response.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Other: Radio chemotherapy

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• France
  • Saint denis, France, 93200
    • CH Saint Denis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients

Description

Inclusion Criteria:

• All patients managed in our facility who achieved a complete response after preoperative radio-chemotherapy.

Exclusion Criteria:

• Minor patients
• Non-responding patients, or partial responders.
• Anal canal cancer

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Particular Case of Patients with Complete Response After CRT Traditionally, for patients with mid o; An initial opportunistic approach, also called Watch and Wait (W&W), involves monitoring patients who are considered to have a complete response after CRT or total neoadjuvant treatment, regardless of the initial stage. This approach was developed by Habr-Gama et al.	Other: Radio chemotherapy; The task involves identifying similarities in biopsy samples (prior to radio-chemotherapy treatment) to predict a hypothetical complete response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
results heterogeneous.	In all patients, a reevaluation was performed using a digital rectal exam (DRE), a rectosigmoidoscopy, a pelvic MRI, and a PET scan.	10/05/2024

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Saint-Denis

Publications and helpful links

Helpful Links

• site web

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2024
• Primary Completion (Actual): May 10, 2024
• Study Completion (Actual): May 10, 2024

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: 0073_CHIRURGIE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No