Colo-rectal CancerDELARCNCT04916054
Time to Surgery and Survival Outcomes for Patients With Resected Colorectal Carcinoma: Multicenter Study (BIG RENAPE)
An observational study of Colo-rectal Cancer, run by Institut Cancerologie de l'Ouest at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer
- How many people
- 227 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Jun 2021to 10 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with a surgery for peritoneal carcinosis of colorectal origin between 2007 and 2019 * Patients from the Institut de cancérologie de l'Ouest and the CHU of Lyon for the study period 2007-2016 * Patients included in the BIG-RENAPE network between 2016 and 2019
Who may be able to join
- Age >18 years
- Histological evidence of peritoneal metastases
- Primary colorectal cancer
- Surgical cytoreduction CC0 or CC1
Who cannot join
- Patient who has not received at least 3 courses of pre and/or post cytoreduction chemotherapy
- Primitive appendicitis
- Unknown primitive
- Patient with incomplete CC2 and/or palliative surgery
- Patient opposed to the use of their data for research.
- Isolated local pelvic recurrence.
- Extraperitoneal metastases not resected or destroyed before or during cytoreduction.
- Patient opposed to the use of his/her data for research purposes
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read more
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.
Read the detailed description
This is a retrospective study including exhaustively all patients operated CC0-CC1 of peritoneal carcinosis between 2007 and 2019 meeting the inclusion criteria:
- Patients from the Institut de cancérologie de l'Ouest and the CHU of Lyon for the study period 2007-2016
- Patients included in the BIG-RENAPE network between 2016 and 2019
- Conditions
- Colo-rectal Cancer
- Medical subject headings
- Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine whether the time between each anti-tumor therapy has a prognostic impact on recurrence-free survival
recurrence-free survival
Measured: 2 years
Secondary outcomes (1)
To evaluate the impact on overall survival
overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start4 Jun 2021
- Primary completion31 Dec 2021
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Sponsor
- Investigators
- Frédéric DUMONT, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916054
- Sponsor's protocol ID
- ICO-2021-10
- Acronym
- DELARC
- Status last verified
- May 2021
- First submitted
- 1 Jun 2021
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Surgery and Survival Outcomes for Patients With Resected Colorectal Carcinoma: Multicenter Study (BIG RENAPE)
- ClinicalTrials.gov ID
- NCT04916054
- Acronym / sponsor ID
- DELARC / ICO-2021-10
- Conditions
- Colo-rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective study including exhaustively all patients operated CC0-CC1 of peritoneal carcinosis between 2007 and 2019 meeting the inclusion criteria:
- Patients from the Institut de cancérologie de l'Ouest and the CHU of Lyon for the study period 2007-2016
- Patients included in the BIG-RENAPE network between 2016 and 2019
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a surgery for peritoneal carcinosis of colorectal origin between 2007 and 2019 * Patients from the Institut de cancérologie de l'Ouest and the CHU of Lyon for the study period 2007-2016 * Patients included in the BIG-RENAPE network between 2016 and 2019
Key inclusion criteria (4 listed)
- Age >18 years
- Histological evidence of peritoneal metastases
- Primary colorectal cancer
- Surgical cytoreduction CC0 or CC1
Key exclusion criteria (8 listed)
- Patient who has not received at least 3 courses of pre and/or post cytoreduction chemotherapy
- Primitive appendicitis
- Unknown primitive
- Patient with incomplete CC2 and/or palliative surgery
- Patient opposed to the use of their data for research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to determine whether the time between each anti-tumor therapy has a prognostic impact on recurrence-free survival
Time frame: 2 years
recurrence-free survival
1 secondary outcome
To evaluate the impact on overall survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric DUMONT, MD principal investigator
Institut de Cancérologie de l'Ouest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer, run by Institut Cancerologie de l'Ouest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to determine whether the time between each anti-tumor therapy has a prognostic impact on recurrence-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.