Colorectal CancerPhase 3NCT00769405
Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
A Phase 3 study testing fluorouracil, leucovorin calcium and oxaliplatin in people with Colorectal Cancer and Primary Peritoneal Cavity Cancer, run by UNICANCER at 20 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- fluorouracil, leucovorin calcium and oxaliplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 20 sitesFrance
- Study dates
- Feb 2008to Dec 2015
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal cancer
- Peritoneal carcinoma extension ≤ 25 (Sugarbaker Index) (determined intraoperatively)
- Planning to receive standard systemic chemotherapy
- Chemotherapy for metastatic cancer should be initiated 3 months after surgery
- No extraperitoneal metastases, including liver and lung metastasis
- No carcinomatosis of other origin besides colorectal, in particular appendical carcinomatosis
- Macroscopically complete resection (R1) or surgical reduction of tumor to a residual thickness ≤ 1 mm (R2) is possible
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Life expectancy > 12 weeks
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN
- Alkaline phosphatase ≤ 3 times ULN
- Creatinine ≤ 1.25 times ULN
- Eligible for surgery
- No peripheral neuropathy > grade 3
- Not pregnant or nursing
- No other cancer in the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- No inability to submit to follow-up medical testing for geographical, social, or psychological reasons
- Affiliated with a social security program
- Not deprived of liberty or under supervision
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemohyperthermia
- No concurrent participation in another study of first-line therapy for this cancer
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Centre Paul Papin
Angers, 49036
Hôpital Antoine Béclère
Clamart, 92141
CHU Estaing
Clermont-Ferrand, 63003
Louis Mourier Hospital
Colombes, 92701
Hopital Du Bocage
Dijon, 21034
CHU de Grenoble - Hopital de la Tronche
Grenoble, 38043
Centre Leon Berard
Lyon, 69373
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, 44805
Hopital de l'Archet CHU de Nice
Nice, F-06202
Institut Curie
Paris, 75005
Hopital Lariboisiere
Paris, 75010
Hôpital Lariboisière
Paris, 75010
Hopital Tenon
Paris, 75970
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Institut Jean Godinot
Reims, 51056
Hopital Universitaire Hautepierre
Strasbourg, 67098
Centre Hospitalier Regional de Purpan
Toulouse, 31059
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, F-94805
About this study
Official title: Phase III Study Evaluating the Use of Systemic Chemotherapy and Chemohyperthemia Intraperitoneal Preoperatively (CHIP) and After Maximum Resection of Peritoneal Carcinomatosis Originating With Colorectal Cancer
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether systemic chemotherapy is more effective with or without intraperitoneal chemohyperthermia in treating patients with peritoneal carcinomatosis from colorectal cancer.
PURPOSE: This randomized phase III trial is studying systemic chemotherapy to see how well it works compared with or without intraperitoneal chemohyperthermia in treating patients undergoing surgery for peritoneal carcinomatosis from colorectal cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare overall survival of patients with peritoneal carcinoma of colorectal origin undergoing complete surgical resection and receiving systemic chemotherapy with versus without intraperitoneal chemohyperthermia.
Secondary
- Evaluate recurrence-free survival of these patients.
- Evaluate treatment toxicities.
- Determine morbidity from surgical complications.
- Determine prognostic factors of survival.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center, residual tumor status (R0/R1 vs R2 ≤ 1 mm), prior regimens of systemic chemotherapy (first vs ≥ second), and preoperative systemic chemotherapy for metastatic disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.
All patients undergo maximal surgical resection of the tumor.
- Arm I: Patients receive standard systemic chemotherapy comprising leucovorin calcium IV followed by fluorouracil IV over 30 minutes. Systemic chemotherapy will continue for at least 6 months (before and/or after surgery). Patients must stop systemic chemotherapy at least 1 month before receiving intraperitoneal chemohyperthermia (CHIP). If bevacizumab is given as neoadjuvant therapy, then systemic chemotherapy must be discontinued 6 weeks before beginning CHIP. Patients undergo CHIP comprising oxaliplatin intraperitoneally during surgery and hyperthermia for 30 minutes.
- Arm II: Patients undergo surgery and receive standard systemic chemotherapy comprising leucovorin calcium IV followed by fluorouracil IV over 30 minutes. Systemic chemotherapy will continue for at least 6 months (before and after surgery).
Tumor markers (ACE and CA 19-9) are assessed at baseline, at 1 month after surgery, and then at follow-up visits.
After completion of study therapy, patients are followed at 1 and 3 months, every 3 months for 3 years, and then every 6 months for 2 years.
- Being tested
- fluorouracil, leucovorin calcium, oxaliplatin, hyperthermia treatment
- Keywords
- recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer, peritoneal carcinomatosis
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorouracilDrug
Given IV
Given IV
oxaliplatinDrug
Given during surgery
hyperthermia treatmentProcedure or surgery
Given intraperitoneally during surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo surgery and receive standard systemic chemotherapy comprising leucovorin calcium IV followed by fluorouracil IV over 30 minutes. Systemic chemotherapy will continue for at least 6 months (before and after surgery). Patients also undergo CHIP comprising oxaliplatin intraperitoneally during surgery and hyperthermia for 30 minutes. Receives: Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Procedure: hyperthermia treatment |
| Arm II | Experimental | Patients undergo surgery and receive standard systemic chemotherapy comprising leucovorin calcium IV followed by fluorouracil IV over 30 minutes. Systemic chemotherapy will continue for at least 6 months (before and after surgery). Receives: Drug: fluorouracil; Drug: leucovorin calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: until 3 years
Secondary outcomes (3)
Recurrence-free survival
Measured: until 3 years
Toxicity by NCI CTCAE v.3.0
Measured: until 5 years after surgery
Morbidity from surgical complications (abdominal, extra-abdominal, aplasia)
Measured: until 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2015
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 CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- 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
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Quenet, MD, Principal investigator, Institut du Cancer de Montpellier - Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769405
- Sponsor's protocol ID
- CDR0000595024
- Other IDs
- FRE-FNCLCC-ACCORD-15/0608, EUDRACT-2006-006175-20, EU-20847
- Status last verified
- Aug 2016
- First submitted
- 8 Oct 2008
- Last updated
- 30 Aug 2016
- Results posted
- No
Publications
Quenet F, Elias D, Roca L, Goere D, Ghouti L, Pocard M, Facy O, Arvieux C, Lorimier G, Pezet D, Marchal F, Loi V, Meeus P, Juzyna B, de Forges H, Paineau J, Glehen O; UNICANCER-GI Group and BIG Renape Group. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):256-266. doi: 10.1016/S1470-2045(20)30599-4. Epub 2021 Jan 18.
PubMed 33476595
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study Evaluating the Use of Systemic Chemotherapy and Chemohyperthemia Intraperitoneal Preoperatively (CHIP) and After Maximum Resection of Peritoneal Carcinomatosis Originating With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00769405
- Acronym / sponsor ID
- CDR0000595024
- Keywords
- recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer, peritoneal carcinomatosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2015 (actual)
- First posted
- 9 Oct 2008 (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.
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether systemic chemotherapy is more effective with or without intraperitoneal chemohyperthermia in treating patients with peritoneal carcinomatosis from colorectal cancer.
PURPOSE: This randomized phase III trial is studying systemic chemotherapy to see how well it works compared with or without intraperitoneal chemohyperthermia in treating patients undergoing surgery for peritoneal carcinomatosis from colorectal cancer.
Detailed description
OBJECTIVES:
Primary
- Compare overall survival of patients with peritoneal carcinoma of colorectal origin undergoing complete surgical resection and receiving systemic chemotherapy with versus without intraperitoneal chemohyperthermia.
Secondary
- Evaluate recurrence-free survival of these patients.
- Evaluate treatment toxicities.
- Determine morbidity from surgical complications.
- Determine prognostic factors of survival.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center, residual tumor status (R0/R1 vs R2 ≤ 1 mm), prior regimens of systemic chemotherapy (first vs ≥ second), and preoperative systemic chemotherapy for metastatic disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.
All patients undergo maximal surgical resection of the tumor.
- Arm I: Patients receive standard systemic chemotherapy comprising leucovorin calcium IV followed by fluorouracil IV over 30 minutes. Systemic chemotherapy will continue for at least 6 months (before and/or after surgery). Patients must stop systemic chemotherapy at least 1 month before receiving intraperitoneal chemohyperthermia (CHIP). If bevacizumab is given as neoadjuvant therapy, then systemic chemotherapy must be discontinued 6 weeks before beginning CHIP. Patients undergo CHIP comprising oxaliplatin intraperitoneally during surgery and hyperthermia for 30 minutes.
- Arm II: Patients undergo surgery and receive standard systemic chemotherapy comprising leucovorin calcium IV followed by fluorouracil IV over 30 minutes. Systemic chemotherapy will continue for at least 6 months (before and after surgery).
Tumor markers (ACE and CA 19-9) are assessed at baseline, at 1 month after surgery, and then at follow-up visits.
After completion of study therapy, patients are followed at 1 and 3 months, every 3 months for 3 years, and then every 6 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: fluorouracil, Drug: leucovorin calcium, Drug: oxaliplatin, Procedure: hyperthermia treatmentPatients undergo surgery and receive standard systemic chemotherapy comprising leucovorin calcium IV followed by fluorouracil IV over 30 minutes. Systemic chemotherapy will continue for at least 6 months (before and after surgery). Patients also undergo CHIP comprising oxaliplatin intraperitoneally during surgery and hyperthermia for 30 minutes. |
| Arm II | Experimental | Drug: fluorouracil, Drug: leucovorin calciumPatients undergo surgery and receive standard systemic chemotherapy comprising leucovorin calcium IV followed by fluorouracil IV over 30 minutes. Systemic chemotherapy will continue for at least 6 months (before and after surgery). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| fluorouracilGiven IV | Drug | Arm I, Arm II |
| leucovorin calciumGiven IV | Drug | Arm I, Arm II |
| oxaliplatinGiven during surgery | Drug | Arm I |
| hyperthermia treatmentGiven intraperitoneally during surgery | Procedure or surgery | Arm I |
Primary outcome
Overall survival
Time frame: until 3 years
3 secondary outcomes
Recurrence-free survival
Time frame: until 3 years
Toxicity by NCI CTCAE v.3.0
Time frame: until 5 years after surgery
Morbidity from surgical complications (abdominal, extra-abdominal, aplasia)
Time frame: until 2 months after surgery
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 30 Aug 2016.
- Derived from this study: PubMed 33476595Quenet F, Elias D, Roca L, Goere D, Ghouti L, Pocard M, Facy O, Arvieux C, Lorimier G, Pezet D, Marchal F, Loi V, Meeus P, Juzyna B, de Forges H, Paineau J, Glehen O; UNICANCER-GI Group and BIG Renape Group. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):256-266. doi: 10.1016/S1470-2045(20)30599-4. Epub 2021 Jan 18.
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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.
Francois Quenet, MD principal investigator
Institut du Cancer de Montpellier - Val d'Aurelle
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fluorouracil, leucovorin calcium and oxaliplatin in people with Colorectal Cancer and Primary Peritoneal Cavity Cancer, run by UNICANCER at 20 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?
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 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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.
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?
Overall survival (time frame: until 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 NCT00769405, 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 30 Aug 2016.