Colorectal Cancer With a Resected Minimal Synchronous PCPhase 3ProphyloCHIPNCT01226394
Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" (Hyperthermic Intraperitoneal Chemotherapy) HIPEC in Colorectal Patients
A Phase 3 study testing laparotomy plus HIPEC in people with Colorectal Cancer With a Resected Minimal Synchronous PC and Ovarian Metastases, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
Multicentric randomised trial. Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC) after resection of their primary will be informed, will sign the consent and will be pre-registered. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer With a Resected Minimal Synchronous PC, Ovarian Metastases, Tumour Rupture in the Abdominal Cavity
- What is being tested?
- laparotomy plus HIPEC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2010to 7 Jan 2021
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with the following history:
- Histologically-proven colorectal adenocarcinoma
- Presenting at the time of resection of the primary with one of the following 4 criteria (criteria indicating a high risk of developing PC) :
- Minimal PC, resected at the same time as the primary
- Ovarian metastases
- Rupture of the primary tumour inside the peritoneal cavity,
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- Iatrogenic rupture of the primary tumour during surgery
- Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) :
- Chemotherapy with the Folfox 4 regimen (the current standard treatment ; it can be modified in the future in the two groups, if the standard is modified…).
- Given on an intent-to-treat basis (it can be stopped prematurely for miscellaneous reasons…);
- Patients who do not present any sign of tumour recurrence at the end of these 6 months of chemotherapy.
- Patients with the following general characteristics:
- Age between 18 and 70 years,
- Performance Status WHO < 2, life expectancy > 12 weeks,
- Haematological parameters : Polynuclear neutrophils ³ 1.5x109/L, platelets ³ 100x109/L,
- Liver function : Total Bilirubin £ 1.5 x ULN, AST (SGOT) et ALT (SGPT) £ 3 x ULN, alkaline phosphatases £ 3 x ULN,
- Renal function : Plasma creatinine £ 1,25 x ULN,
- Operable patients,
- Grade £ 2 peripheral neuropathy (CTC AE v3.0 annex 7)
- Patients entitled to French National Health Insurance coverage.
- E)Patients will be informed and a signed consent form will be obtained before initiating any procedure specific to the trial.
Who cannot join
- Cancers of non colorectal origin, particularly, appendiceal cancers are excluded
- Patients presenting with a detectable recurrent tumour
- Grade ≥ 3 Peripheral neuropathy
- History of cancer (excepted cutaneous basocellullar cancer or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years
- Patients already included in another trial concerning first-line treatment 6) Pregnant women or likely to be pregnant
- 7) Persons under guardianship 8) Follow-up impossible for geographic, social or psychological reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric Phase III Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" HIPEC (Hyperthermic Intraperitoneal Chemotherapy) in Colorectal Patients Initially Treated With Surgery and Adjuvant Chemotherapy Who Have a High Risk of Developing Colorectal Peritoneal Carcinomatosis
Multicentric randomised trial. Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC) after resection of their primary will be informed, will sign the consent and will be pre-registered. All patients will receive the current standard adjuvant treatment : 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified). Then a work-up is done to exclude recurrence. The likelihood of a recurrence is low but if this occurs, the patient will not be randomised and will be treated with the best known treatment. If the work-up is negative, patients will be randomised to surveillance alone (control group) or exploratory laparotomy + HIPEC (experimental group).
- Conditions
- Colorectal Cancer With a Resected Minimal Synchronous PC, Ovarian Metastases, Tumour Rupture in the Abdominal Cavity
- Being tested
- laparotomy plus HIPEC
- Keywords
- peritoneal carcinomatosis, HIPEC, controlled clinical trial
- Medical subject headings
- Krukenberg Tumor, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparotomy plus HIPECProcedure or surgery
Laparotomy + HIPEC
| Study group | Role | What they receive |
|---|---|---|
| surveillance | No intervention | Not described |
| laparotomy plus HIPEC. | Experimental | Not described Receives: Procedure: laparotomy plus HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
To increase the 3-year disease-free survival
3-year disease-free survival
Measured: 3 years
Secondary outcomes (3)
3 year overall survival
Measured: 3 years
Peritoneal disease-free survival
Measured: 3 years
5 year overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study start11 Jun 2010
- Primary completion19 Mar 2018
- Study completion7 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer With a Resected Minimal Synchronous PCStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diane GOERE, MD, Study chair, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226394
- Sponsor's protocol ID
- CSET 1539-ProphyloCHIP
- Other IDs
- 2009-015598-11, 2009
- Acronym
- ProphyloCHIP
- Status last verified
- Mar 2026
- First submitted
- 20 Oct 2010
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goere D, Glehen O, Quenet F, Guilloit JM, Bereder JM, Lorimier G, Thibaudeau E, Ghouti L, Pinto A, Tuech JJ, Kianmanesh R, Carretier M, Marchal F, Arvieux C, Brigand C, Meeus P, Rat P, Durand-Fontanier S, Mariani P, Lakkis Z, Loi V, Pirro N, Sabbagh C, Texier M, Elias D; BIG-RENAPE group. Second-look surgery plus hyperthermic intraperitoneal chemotherapy versus surveillance in patients at high risk of developing colorectal peritoneal metastases (PROPHYLOCHIP-PRODIGE 15): a randomised, phase 3 study. Lancet Oncol. 2020 Sep;21(9):1147-1154. doi: 10.1016/S1470-2045(20)30322-3. Epub 2020 Jul 24.
PubMed 32717180
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Phase III Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" HIPEC (Hyperthermic Intraperitoneal Chemotherapy) in Colorectal Patients Initially Treated With Surgery and Adjuvant Chemotherapy Who Have a High Risk of Developing Colorectal Peritoneal Carcinomatosis
- ClinicalTrials.gov ID
- NCT01226394
- Acronym / sponsor ID
- ProphyloCHIP / CSET 1539-ProphyloCHIP
- Conditions
- Colorectal Cancer With a Resected Minimal Synchronous PC, Ovarian Metastases, Tumour Rupture in the Abdominal Cavity
- Keywords
- peritoneal carcinomatosis, HIPEC, controlled clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 11 Jun 2010 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 22 Oct 2010 (estimated)
- 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.
Multicentric randomised trial. Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC) after resection of their primary will be informed, will sign the consent and will be pre-registered. All patients will receive the current standard adjuvant treatment : 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified). Then a work-up is done to exclude recurrence. The likelihood of a recurrence is low but if this occurs, the patient will not be randomised and will be treated with the best known treatment. If the work-up is negative, patients will be randomised to surveillance alone (control group) or exploratory laparotomy + HIPEC (experimental group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surveillance | No intervention | – |
| laparotomy plus HIPEC. | Experimental | Procedure: laparotomy plus HIPEC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients presenting with the following history:
- Histologically-proven colorectal adenocarcinoma
- Presenting at the time of resection of the primary with one of the following 4 criteria (criteria indicating a high risk of developing PC) :
- Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) :
- Chemotherapy with the Folfox 4 regimen (the current standard treatment ; it can be modified in the future in the two groups, if the standard is modified…).
Key exclusion criteria (6 listed)
- Cancers of non colorectal origin, particularly, appendiceal cancers are excluded
- Patients presenting with a detectable recurrent tumour
- Grade ≥ 3 Peripheral neuropathy
- History of cancer (excepted cutaneous basocellullar cancer or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years
- Patients already included in another trial concerning first-line treatment 6) Pregnant women or likely to be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparotomy plus HIPECLaparotomy + HIPEC | Procedure or surgery | laparotomy plus HIPEC. |
Primary outcome
To increase the 3-year disease-free survival
Time frame: 3 years
3-year disease-free survival
3 secondary outcomes
3 year overall survival
Time frame: 3 years
Peritoneal disease-free survival
Time frame: 3 years
5 year overall survival
Time frame: 5 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 6 Apr 2026.
- Derived from this study: PubMed 32717180Goere D, Glehen O, Quenet F, Guilloit JM, Bereder JM, Lorimier G, Thibaudeau E, Ghouti L, Pinto A, Tuech JJ, Kianmanesh R, Carretier M, Marchal F, Arvieux C, Brigand C, Meeus P, Rat P, Durand-Fontanier S, Mariani P, Lakkis Z, Loi V, Pirro N, Sabbagh C, Texier M, Elias D; BIG-RENAPE group. Second-look surgery plus hyperthermic intraperitoneal chemotherapy versus surveillance in patients at high risk of developing colorectal peritoneal metastases (PROPHYLOCHIP-PRODIGE 15): a randomised, phase 3 study. Lancet Oncol. 2020 Sep;21(9):1147-1154. doi: 10.1016/S1470-2045(20)30322-3. Epub 2020 Jul 24.
- Related InfoLink provided by the sponsor.
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.
Diane GOERE, MD study chair
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing laparotomy plus HIPEC in people with Colorectal Cancer With a Resected Minimal Synchronous PC and Ovarian Metastases, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site 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 21 inclusion and 6 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 increase the 3-year disease-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01226394, which also lists 1 linked publication.
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 6 Apr 2026.