JPRN-UMIN000031780
Completed
Phase 3
Extensive Peritoneal Lavage after Curative Gastrectomy for Gastric Cancer: a Randomized Controlled Trial (EXPEL Study) - Extensive Peritoneal Lavage for Gastric Cancer (P3)
ational University Hospital, Singapore0 sites800 target enrollmentStarted: March 21, 2018Last updated:
ConditionsGastric cancer
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- ational University Hospital, Singapore
- Enrollment
- 800
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 21years-old to 80years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\.Patients who undergo a palliative gastrectomy. 2\.Patients who undergo a gastrectomy as emergency. 3\.Vulnerable persons under age of 21\. 4\.Patients receiving neoadjuvant therapy. 5\.Patients presented with life\-threatening bleeding from tumour 6\.ASA score of 4 \& 5 7\.Patients with another primary cancer within last 5 years 8\.Patients with gross peritoneal and liver metastasis at surgery.
Investigators
Similar Trials
Unknown
Not Applicable
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A study designed to compare the effect of two treatment types in gastric cancer patients with peritoneal metastasis, standard systemic chemotherapy vs surgery combined with hyperthermic chemotherapy in the abdominal cavity.Gastric cancer with peritoneal carcinomatosis or tumour positive cytologyMedDRA version: 20.0Level: HLTClassification code 10017812Term: Gastric neoplasms malignantSystem Organ Class: 100000004856MedDRA version: 21.0Level: PTClassification code 10061269Term: Malignant peritoneal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10057647Term: Cytoreductive surgerySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: LLTClassification code 10067093Term: Intraperitoneal hyperthermic chemotherapySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10061965Term: GastrectomySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: LLTClassification code 10052171Term: Peritoneal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2015-005695-15-NLKI-AV226