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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-FNCLCC-ACCORD-15/0608 | |||
| EUDRACT-2006-006175-20 | |||
| EU-20847 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorouracil | Drug | Given IV |
| |
| leucovorin calcium |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | until 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival | until 3 years | |
| Toxicity by NCI CTCAE v.3.0 | until 5 years after surgery | |
| Morbidity from surgical complications (abdominal, extra-abdominal, aplasia) |
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DISEASE CHARACTERISTICS:
Histologically confirmed colorectal cancer
Peritoneal carcinoma extension ≤ 25 (Sugarbaker Index) (determined intraoperatively)
Planning to receive standard systemic chemotherapy
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Francois Quenet, MD | Institut du Cancer de Montpellier - Val d'Aurelle | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Papin | Angers | 49036 | France | |||
| Hôpital Antoine Béclère |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33476595 | Derived | 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. |
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| Drug |
Given IV |
|
| oxaliplatin | Drug | Given during surgery |
|
| hyperthermia treatment | Procedure | Given intraperitoneally during surgery |
|
| until 2 months after surgery |
| Clamart |
| 92141 |
| France |
| CHU Estaing | Clermont-Ferrand | 63003 | France |
| Louis Mourier Hospital | Colombes | 92701 | France |
| Hopital Du Bocage | Dijon | 21034 | France |
| CHU de Grenoble - Hopital de la Tronche | Grenoble | 38043 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | 34298 | France |
| Centre Regional Rene Gauducheau | Nantes-Saint Herblain | 44805 | France |
| Hopital de l'Archet CHU de Nice | Nice | F-06202 | France |
| Institut Curie | Paris | 75005 | France |
| Hopital Lariboisiere | Paris | 75010 | France |
| Hôpital Lariboisière | Paris | 75010 | France |
| Hopital Tenon | Paris | 75970 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Institut Jean Godinot | Reims | 51056 | France |
| Hopital Universitaire Hautepierre | Strasbourg | 67098 | France |
| Centre Hospitalier Regional de Purpan | Toulouse | 31059 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| Institut Gustave Roussy | Villejuif | F-94805 | France |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000008 | Abdominal Neoplasms |
| D010532 | Peritoneal Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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