Program to assess tumor response in rectal cancer patients

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 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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Dijon Bourgogne
  Dijon, France Recruiting

Study contacts

• Study coordinator: Quentin DENOST
• Email: q.denost@bordeaux-colorectal-institute.fr
• Phone: 05 47 50 15 75

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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.