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
Peritoneal carcinosis (PC) corresponds to a locoregional extension into the peritoneum of rare primary peritoneal cancers, or more frequently distant extension of digestive cancers (colorectal or gastric) or gynecological (ovarian, fallopian tube, or endometrial). PC can be considered as a distinct oncological entity as its genesis, natural history, and response to systematic treatments differ to those of other metastases. The development of PC, observed in 25-35% of colorectal cancers, is generally considered as a unfavorable event in the course of the disease. The prognosis is defined by the possibility of complete resection, possibly after neoadjuvant treatment. The benefit provided by the combination of cytoreductive surgery and heated intraperitoneal chemotherapy (HIPEC) with respect to systemic chemotherapy in patients with PC of colorectal origin has been demonstrated based on overall survival in several randomized trials, among which one evaluated oxaliplatin. The evaluation of the clinical benefit-risk related to the repeated administration of non-hyperthermic intraperitoneal chemotherapy, as has been validated in ovarian cancer, in patients with PC of colorectal origin is already being investigated by several international teams.
The FOLFOXIRI + bevacizumab every 2 weeks is a modern therapeutic option in patients with this disease. The intraperitoneal rather than intravenous (IV) administration of oxaliplatin, in this combination, could increase the response of peritoneal lesions known to be relatively insensitive to IV chemotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with peritoneal carcinosis | Experimental | Patients with peritoneal carcinosis of colorectal origin and uncertain resectability with an indication for systemic chemotherapy compatible with the FOLFIRI + bevacizumab combination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapy | Drug | Intraperitoneal (IP) OXAliplatin (OXA) in association with systemic FOLFIRI bevacizumab chemotherapy Intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI (Irinotecan IV + 5-FU IV) bevacizumab chemotherapy in escalation dose (every 14 days) starting with the level 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (NCI CTCAE v4.0) | The safety of intraperitoneal (IP) administration of oxaliplatin in combination with systemic chemotherapy FOLFIRI + bevacizumab will be evaluated during the first cycle of therapy according to NCI CTCAE version 4.0 | up to 14 days |
| Dose Limiting Toxicities, DLT | The safety of intraperitoneal (IP) administration of oxaliplatin in combination with systemic chemotherapy FOLFIRI + bevacizumab will be evaluated during the first cycle of therapy according to Dose Limiting Toxicities | up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate according to RECIST | Clinical efficacy of intraperitoneal (IP) administration of oxaliplatin in combination with systemic FOLFIRI + bevacizumab assessed by the overall response rate according to RECIST version 1.1 criteria assessed by imaging (TAP scanner and / or MRI if contraindication) performed after 4 cycles, and / or after 8 cycles | up to 4 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benoit You, MD | Contact | (0)4 78 86 43 18 | +33 | benoit.you@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Benoit You, MD | Service d'Oncologie Médicale, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud 69495 Pierre-Bénite | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Estaing | Not yet recruiting | Clermont-Ferrand | 63003 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapy | Drug | systemic FOLFIRI chemotherapy |
|
| intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapy | Drug | bevacizumab |
|
| Peritoneal Cancer Index (PCI) | Clinical efficacy of intraperitoneal (IP) administration of oxaliplatin in combination with systemic FOLFIRI + bevacizumab assessed by Peritoneal Cancer Index (PCI) performed after 4 cycles, and / or after 8 cycles | up to 4 months |
| Adverse events (NCI CTCAE v4.0) | The safety of intraperitoneal (IP) administration of oxaliplatin in combination with systemic chemotherapy FOLFIRI + bevacizumab will be evaluated throughout the duration of treatment (4 months) and until the end of patient follow up (1 month after treatment discontinuation) according to NCI CTCAE version 4.0 | up to 5 months |
| The quality of life (EORTC QLQ-C30) | The quality of life will be evaluated throughout the duration of treatment (4 months max) after the end of cycle 2, 4, 6 and 8 of chemotherapy according to EORTC QLQ-C30 . | up to 4 months |
| The quality of life (EORTC QLQ-C29) | The quality of life will be evaluated throughout the duration of treatment (4 months max) after the end of cycle 2, 4, 6 and 8 of chemotherapy according to EORTC QLQ-C29. | up to 4 months |
| Service de Chirurgie Digestive et de l'Urgence, CHU Albert Michallon | Not yet recruiting | Grenoble | 38700 | France |
|
| Département de Chirurgie Cancérologique, Centre Léon Bérard | Not yet recruiting | Lyon | 69373 | France |
|
| Service d'Oncologie Médicale, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud | Recruiting | Pierre-Bénite | 69495 | France |
|
| Service de Chirurgie Digestive et Cancérologique, CHU NORD | Not yet recruiting | Saint-Etienne | 42055 | France |
|
| Service Oncologie Médicale, INSTITUT DE CANCEROLOGIE DE LA LOIRE (ICL) | Not yet recruiting | Saint-Priest-en-Jarez | 42270 | France |
|
| ID | Term |
|---|---|
| D007263 | Infusions, Parenteral |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided