NCT07467434

Brief Summary

SYNCHRONOX is a multicenter cohort (retrospective then prospective) intending to include 550 patients with mid or low rectal adenocarcinoma (pMMR, T3-T4 and/or N+) and resectable synchronous liver metastases, treated upfront with at least two cycles of induction FOLFIRINOX chemotherapy. The primary objective is to determine, at 18 months, the R0 resection rate of both tumor sites (rectum and liver), while secondary objectives focus on 3 year overall and progression free survival, radiological and pathological responses, postoperative morbidity and mortality, and comparison of the different surgical strategies after FOLFIRINOX.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
96mo left

Started Apr 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Apr 2034

First Submitted

Initial submission to the registry

March 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2034

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

March 8, 2026

Last Update Submit

March 8, 2026

Conditions

Rectal CancerSynchronous Liver MetastasesAntineoplastic Combined Chemotherapy ProtocolsSurgical Therapy

Keywords

Prospective observational multicentric cohortRetrospective observational multicentric cohort

Outcome Measures

Primary Outcomes (1)

  • Curative resection rate of both tumor sites after induction chemotherapy with FOLFIRINOX

    For rectal cancer, resection is considered curative in cases of R0 resection (distal margin ≥ 1 cm and circumferential resection margin \> 1 mm). Non-surgical organ preservation is also considered curative treatment in cases of complete clinical response not followed by tumor regrowth during the first year. For liver metastases, resection is considered curative if all visible lesions have been resected R0 (resection margin \> 1 mm) or destroyed by radiofrequency.

    18 months from the start of chemotherapy with FOLFIRINOX

Secondary Outcomes (13)

  • Overall 3-year survival rate

    3 years from the start of chemotherapy with FOLFIRINOX

  • Three-year progression-free survival rate

    3 years from the start of chemotherapy with FOLFIRINOX

  • Complete resection rate (R0) of rectal tumors

    30 days after rectal resection

  • Complete resection rate (R0) of liver lesions

    30 days after liver resection

  • Radiological response grade of rectal tumor to preoperative treatment

    1 month after the end of neoadjuvant therapy

  • +8 more secondary outcomes

Study Arms (1)

Patients with rectal cancer with resectable synchronous liver metastases, treated with FOLFIRINOX

Follow-up as part of the usual care of patients with mid/lower rectal cancer with resectable synchronous liver metastases, treated with FOLFIRINOX induction chemotherapy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with mid/lower rectal cancer with resectable synchronous liver metastases, treated with FOLFIRINOX induction chemotherapy

You may qualify if:

  • Adult subjects aged 18 years and older
  • Adenocarcinoma of the middle and/or lower rectum pMMR T3, T4, and/or N+
  • Resectable synchronous liver metastases

You may not qualify if:

  • Minor under the age of 18.
  • Presence of extrahepatic metastases
  • Induction chemotherapy with FOLFIRINOX of less than 2 courses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Digestive Surgery Department, Bicêtre University Hospital AP-HP

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Stéphane BENOIST, MD PhD

CONTACT

+33 (0)1 45 21 34 72stephane.benoist@aphp.fr

Solafah ABDALLA, MD PhD

CONTACT

+33 (0)1 45 21 34 70solafah.abdalla@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2026

First Posted

March 12, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

April 1, 2034

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)