NCT06197425: CIRCULATE PAC

Phase III Multicentric, Open-label, Randomized Study to Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer (PRODIGE 88)

Recruiting now Phase 3 Last updated 19 May 2026

What this trial tests

Phase 3 trial testing "FOLFIRI" cures in Colon or Upper Rectum Adenocarcinoma in 1,660 participants. Currently enrolling.

Timeline

7 May 2026

Primary endpoint
1 May 2032

1 May 2032

Quick facts

Lead sponsor	Centre Hospitalier Universitaire Dijon
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,660
Start date	7 May 2026
Primary completion	1 May 2032
Estimated completion	1 May 2032
Sites	1 location across France

Drugs / interventions tested

• "FOLFIRI" cures — full drug profile →
• Trifluridine cures — full drug profile →
• BIOLOGICAL ASSESSMENT — full drug profile →
• Questionnaires
• Thoracic-abdomino-pelvic scan or MRI

Conditions studied

• Colon or Upper Rectum Adenocarcinoma — all drugs for Colon or Upper Rectum Adenocarcinoma →

Sponsor

Centre Hospitalier Universitaire Dijon

Who can join

Adults 18 to 80, any sex, with Colon or Upper Rectum Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The time to recurrence (TTR)
  Time frame: From date of randomization until the date of first documented progression or date of death from colorectal cancer
  The time to recurrence (TTR), in patients treated by FOLFIRI vs surveillance inside the study and in patients treated by Trifluridine Tipiracil vs surveillance inside the study. This TTR is defined as time from randomization to disease recurrence including locoregional or metastatic relapse, death with evidence of recurrence and death from CRC cause.

Sponsor's own description

Phase III multicentric, open-label, randomized study

The main objective is to assess the efficacy on time to disease recurrence (TTR) of treating minimal residual disease diagnosed by the presence of ctDNA after full treatment (surgery + chemotherapy) in stage III or high-risk stage II colon or upper rectum adenocarcinoma

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical utility and future perspectives of liquid biopsy in colorectal cancer.
   Patelli G, Lazzari L, Crisafulli G, Sartore-Bianchi A, et al · · 2025 · cited 7× · PMID 40275061 · DOI 10.1038/s43856-025-00852-4