Implementation of a Tumor Response Assessment Program Integrating the Shared Medical Decision Into the Organ Preservation Strategy for Rectal Cancer Patients

NCT ID: NCT06740357

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-10
• Study Completion Date: 2031-03-31

Brief Summary

The adoption of total mesorectal excision (TME) has standardized rectal cancer surgery and improved oncological outcomes. In locally advanced rectal cancer, neoadjuvant radio chemotherapy (NACRT) has further improved oncological benefit. Although these strategies result in good 5-year disease-free survival rates, they are associated with significant morbidity, in particular permanent long-term bowel, urinary and sexual dysfunction. In rectal cancer management, the main objective of organ preservation is to avoid or reduce morbidity and impact on quality of life after rectal resection, without compromising oncological outcomes.

The aim of this project is to evaluate the efficacy of a defined response monitoring program, including a shared decision process, as a strategy for assessing tumor response in locally advanced rectal cancer after neoadjuvant therapy.

This is a national, phase III, randomized, open-label, multicenter clinical trial comparing the tumor response monitoring program with shared decision-making, versus standard tumor response assessment in organ preservation strategies in rectal cancer.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental: Tumor response monitoring program with shared decision-making

Group Type: EXPERIMENTAL

Tumor response monitoring program

Intervention Type: OTHER

three steps of tumor response evaluation (STEP 1 at 2 months, STEP 2 at 4 months, STEP 3 at 6 months after completion of neoadjuvant treatment): STEP 1: digital rectal examination, pelvic MRI, rectoscopy, TAP scan STEP 2: DRE, pelvic MRI, rectoscopy STEP 3: DRE, pelvic MRI, rectoscopy, TAP or PET scan

Shared decision-making

Intervention Type: OTHER

At each stage of the monitoring program and depending on the clinical and oncological results, the decision to preserve the rectum will be discussed with the patient according to a shared-decision program.

Follow-up

Intervention Type: OTHER

Every 3 months for 2 years, then every 6 months for the third year

Control: Standard assessment of tumor response (validated in the GRECCAR 2 trial - Lancet 2017)

Group Type: ACTIVE_COMPARATOR

Standard evaluation of tumor response

Intervention Type: OTHER

Assessment at 2 months (+/- 7 days) after neoadjuvant treatment: digital rectal exam, pelvic MRI, rectoscopy, TAP scan

Decision-making according to national recommendations

Intervention Type: OTHER

The decision to preserve the rectum is based on assessment at 2 months after completion of neoadjuvant treatment (standard of care since the GRECCAR2 trial).

Follow-up

Intervention Type: OTHER

Every 3 months for 2 years, then every 6 months for the third year

Interventions

Tumor response monitoring program

three steps of tumor response evaluation (STEP 1 at 2 months, STEP 2 at 4 months, STEP 3 at 6 months after completion of neoadjuvant treatment): STEP 1: digital rectal examination, pelvic MRI, rectoscopy, TAP scan STEP 2: DRE, pelvic MRI, rectoscopy STEP 3: DRE, pelvic MRI, rectoscopy, TAP or PET scan

Intervention Type: OTHER

Standard evaluation of tumor response

Assessment at 2 months (+/- 7 days) after neoadjuvant treatment: digital rectal exam, pelvic MRI, rectoscopy, TAP scan

Intervention Type: OTHER

Shared decision-making

At each stage of the monitoring program and depending on the clinical and oncological results, the decision to preserve the rectum will be discussed with the patient according to a shared-decision program.

Intervention Type: OTHER

Decision-making according to national recommendations

The decision to preserve the rectum is based on assessment at 2 months after completion of neoadjuvant treatment (standard of care since the GRECCAR2 trial).

Intervention Type: OTHER

Follow-up

Every 3 months for 2 years, then every 6 months for the third year

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Dijon Bourgogne

Dijon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Quentin DENOST

Role: CONTACT

q.denost@bordeaux-colorectal-institute.fr

05 47 50 15 75

Facility Contacts

Antoine DROUILLARD

Role: primary

antoine.drouillard@chu-dijon.fr

03 80 29 37 50

Other Identifiers

DROUILLARD PHRCK 2023-2

Identifier Type: -

Identifier Source: org_study_id