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NCT04916054: DELARC
Time to Surgery and Survival Outcomes for Patients With Resected Colorectal Carcinoma: Multicenter Study (BIG RENAPE)
trial in Colo-rectal Cancer in 227 participants. Completed in 10 March 2022.
31 December 2021
Quick facts
| Lead sponsor | Institut Cancerologie de l'Ouest |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 227 |
| Start date | 4 June 2021 |
| Primary completion | 31 December 2021 |
| Estimated completion | 10 March 2022 |
| Sites | 2 locations across France |
Conditions studied
- Colo-rectal Cancer — all drugs for Colo-rectal Cancer →
Sponsor
Institut Cancerologie de l'Ouest — full company profile →
Who can join
18 and older, any sex, with Colo-rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Colorectal cancer (CRC) is diagnosed in one million patients each year worldwide and is the 2nd leading cause of cancer death. Peritoneal metastasis (MP) is seen in 10% of CRC patients and is the metastatic site with the worst prognosis. Complete cytoreduction surgery (CCS) is the only treatment that allows for prolonged survivals. Five-year overall survival (OS) after CCS ranges from 30% to 60% compared with 0 to 5% with exclusive medical treatment. Chemotherapy (CT) with fluoropyrimidine and oxaliplatin and/or irinotecan 3 months pre-operatively and 3 months adjuvant is widely used. The benefits of perioperative CT have been demonstrated in another resectable metastatic site, the liver and has become by extension a therapeutic standard in France for CRC MPs. However, the impact of delay in the initiation of surgery and adjuvant or neoadjuvant CT is unknown for CRC MPs. Several deleterious oncologic effects are related to a long period without treatment between * Neoadjuvant chemotherapy and surgery: * Surgery and adjuvant chemotherapy. Several meta-analyses have demonstrated, for at least 13 different cancers, a continuous association between delays in treatment (CT, radiotherapy, or surgery) and cancer mortality. For CRC, Hanna's meta-analysis showed that for every 4-week delay in adjuvant surgery or CT, the risk of cancer death increased by 6 and 13%, respectively. These long delays between CT and excisional surgery also decrease survival in patients with liver metastases from colorectal origins and MPs from ovarian origins but this has never been evaluated in patients with MPs from colorectal origins. Demonstrating an oncologic impact of therapeutic delays would have several strategic practical impacts such as: * Promoting pre- and post-operative rehabilitation programs to facilitate recovery and reduce time to retreatment. * To use more easily techniques (protective stoma, multi-stage surgery) limiting the risk of complications and therefore the delays in treatment. * Propose clinical research protocols aimed at reducing these delays with knowledge of plausible statistical hypotheses. A therapeutic strategy of shortening the time between each treatment therefore deserves to be evaluated in metastatic forms of colorectal cancer. The investigators would like to evaluate the hypothesis that shortened time between treatments could have a prognostic impact on recurrence-free survival.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04916054
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Institut Cancerologie de l'Ouest trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04916054 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut Cancerologie de l'Ouest
- Last refreshed: 13 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04916054.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing