Program to assess tumor response in rectal cancer patients

Implementation of a Tumor Response Assessment Program Integrating Shared Medical Decision Making Into the Organ Preservation Strategy for Rectal Cancer Patients: Phase III Randomized - Multicenter

This study is testing a new way to monitor how well treatment is working for patients with locally advanced rectal cancer to see if it can improve their outcomes and quality of life compared to standard methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Centre Hospitalier Universitaire Dijon (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Dijon)
• Trial ID: NCT06740357 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a tumor response monitoring program that integrates shared decision-making for patients with locally advanced rectal cancer undergoing neoadjuvant therapy. The program aims to assess tumor response effectively while minimizing morbidity associated with traditional surgical approaches. By comparing this new monitoring strategy to standard evaluation methods, the trial seeks to enhance patient outcomes and quality of life post-treatment. The study is a national, phase III, randomized, open-label, multicenter trial conducted at multiple sites.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with locally advanced rectal cancer who are scheduled to receive neoadjuvant treatment.

Not a fit: Patients with distant metastasis or those whose tumors invade the anal canal or sphincters may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could lead to improved quality of life for rectal cancer patients by reducing treatment-related morbidity.

How similar studies have performed: Other studies have shown promise in integrating shared decision-making in cancer treatment, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Patient aged 18 to 80
* Histologically proven lieberkuhnian adenocarcinoma with MSS status ;
* Patient who has or is due to receive neoadjuvant treatment (4 to 6 courses of (m)FOLFIRINOX or FOLFOX chemotherapy + CAP 50 radiochemotherapy or CAP 50 radiochemotherapy alone);
* BEFORE any neoadjuvant treatment:

  * Tumor classified T2T3 (on MRI)
  * N0-N1 (≤ 3 positive lymph nodes \* or size ≤ 8 mm) (on MRI)
  * \* positive node = node size \> 5 mm minor axis and/or morphologically suspicious appearance Tumor size ≤4 cm (ON MRI)
  * No distant metastasis (M0)\_ TAP scan or PET scan
  * ≤ 8 cm from anal margin (On MRI) (Clinical examination\*)

    \*if the clinical examination is not possible, then the source data is that of the MRI.
  * No invasion of the anal canal and/or sphincters (internal and external) (On MRI)
* Operable patient
* Ability to comply with the protocol and follow-up appointments (repeated assessment consultations and close follow-up if randomized to the Experimental Group);
* Person affiliated with or benefiting from a social security scheme;
* Free and informed consent signed by the patient.

Exclusion Criteria:

* Patients with a history of chemotherapy or pelvic irradiation (excluding neoadjuvant treatment)
* Contraindication to pelvic MRI
* Patients with MSI status undergoing immunotherapy
* Other concomitant cancer or history of cancer within 5 years, with the exception of carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma or any other carcinoma in situ, considered cured
* Women who are pregnant, likely to become pregnant, or who are breast-feeding;
* Person under guardianship, curatorship or safeguard of justice, or person deprived of liberty.
* Unable to undergo medical follow-up for geographical, social or psychological reasons.

Where this trial is running

Dijon

• CHU Dijon Bourgogne — Dijon, France (Recruiting)

Study contacts

• Study coordinator: Quentin DENOST

Conditions Rectal Cancer