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

NCT06740357 | Recruiting

• 1 other identifier: DROUILLARD PHRCK 2023-2
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Organ preservation rate

  An organ-preserving patient is defined as a patient who has not undergone rectal resection.

  2 years after the start of neoadjuvant treatment

Study Arms (2)

Experimental: Tumor response monitoring program with shared decision-making

EXPERIMENTAL

Other: Tumor response monitoring program; Other: Shared decision-making; Other: Follow-up

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

ACTIVE COMPARATOR

Other: Standard evaluation of tumor response; Other: Decision-making according to national recommendations; Other: Follow-up

Interventions

Tumor response monitoring program 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

Experimental: Tumor response monitoring program with shared decision-making

Standard evaluation of tumor response OTHER

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

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

Shared decision-making 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.

Experimental: Tumor response monitoring program with shared decision-making

Decision-making according to national recommendations 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).

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

Follow-up 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); Experimental: Tumor response monitoring program with shared decision-making

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Quentin DENOST

CONTACT

05 47 50 15 75; q.denost@bordeaux-colorectal-institute.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

FR (1)