Peritoneal Carcinosis Clinical Trial
Official title:
IPOXA, Phase I/II Dose Escalation Trial Aiming to Evaluate the Safety of Intraperitoneal (IP) OXAliplatin (OXA) in Association With Systemic FOLFIRI Bevacizumab Chemotherapy in Patients With Peritoneal Carcinosis of Colorectal Origin and Uncertain Resectability.
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04221464 -
Development of a Clinical and Biological Database in Peritoneal Carcinosis (BCB CARCINOSE)
|
N/A |