Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015598-11 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surveillance | No Intervention | ||
| laparotomy plus HIPEC. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparotomy plus HIPEC | Procedure | Laparotomy + HIPEC |
|
| Measure | Description | Time Frame |
|---|---|---|
| To increase the 3-year disease-free survival | 3-year disease-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 3 year overall survival | 3 years | |
| Peritoneal disease-free survival | 3 years | |
| 5 year overall survival |
Not provided
Inclusion Criteria:
A) 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) :
B) Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) :
C) Patients who do not present any sign of tumour recurrence at the end of these 6 months of chemotherapy.
D) Patients with the following general characteristics:
E)Patients will be informed and a signed consent form will be obtained before initiating any procedure specific to the trial.
Exclusion Criteria:
7) Persons under guardianship 8) Follow-up impossible for geographic, social or psychological reasons
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Diane GOERE, MD | Gustave Roussy, Cancer Campus, Grand Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Gustave Roussy | Villejuif | 94800 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32717180 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 5 years |
| ID | Term |
|---|---|
| D007725 | Krukenberg Tumor |
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D018279 | Carcinoma, Signet Ring Cell |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007813 | Laparotomy |
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
Not provided
Not provided