Effect of the administration of intraperitonel aerosolized chemotherapy in patients with unresectable peritoneal metastases from digestive, ovary and peritoneal origi

Phase 1

• Conditions: Patient presenting unresectable peritoneal metastases from digestive system, ovary or primary peritoneal origin; MedDRA version: 21.1Level: PTClassification code 10051676Term: Metastases to peritoneumSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-001417-36-ES
• Lead Sponsor: HOSPITAL CLINICO UNIVERSITARIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

- Age between 18 and 75 years
- Diagnosis of unresectable peritoneal carcinomatosis - (Decided in tumor board)
- Diagnosis of peritoneal carcinomatosis of the following origins:
- High-grade serous ovarian carcinoma unresponsive to 2 lines of intravenous chemotherapy
- Colon adenocarcinoma
- Gastric adenocarcinoma
- Epithelioid variety of peritoneal mesothelioma
- ECOG <= 2
- Patients in whom resective procedures or intestinal anastomoses are NOT going to be performed
- Signature of the informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

- Distant extraperitoneal metastases
- Life expectancy <3 months
- Presence of intestinal obstruction
- Severe organ or system dysfunction
- ECOG> 2
- Contraindication of administration of the chemotherapeutic drug contained in the specific protocol for that tumor
- Previous abdominal surgery in the 4 weeks prior to administration
- Patients with concomitant administration of immunosuppressants
- Pregnant or breastfeeding patients
- Decompensated ascites (> 3000 c.c.)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified