Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT02672865|
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : April 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Malignant Neoplasm Gastric Cancer||Drug: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)||Phase 1|
Patients undergoing definitive resection for gastric cancer and meeting the eligibility criteria will be treated with HIPEC using a single dose of Mitomycin 15mg/m2 and Cisplatin 50mg/m2 at 41-42 C for 90 minutes. HIPEC will be performed after resection but before anastomosis. Both Cisplatin and Mitomycin are commercially available chemotherapeutic agents and will be obtained as marketed drugs.
Patients will be followed for 90 days following surgery. All postoperative complications will be recorded and graded according to the modified Clavien-Dindo classification.
Schedule for Follow Up:
Trial-related patient assessments will be performed daily while the patient remains in the hospital for postoperative care, and then during postoperative clinic visits. The final postoperative clinic visit for evaluation of study outcomes and complications should occur between postoperative days 90 and 95 to allow for a cumulative assessment of the patient's perioperative complications, if any.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer|
|Actual Study Start Date :||February 2, 2016|
|Actual Primary Completion Date :||October 3, 2018|
|Actual Study Completion Date :||October 3, 2018|
The administration of hyperthermic intraperitoneal chemotherapy (HIPEC), using a warm solution of two chemotherapy medications (mitomycin and cisplatin) to bathe the internal surfaces of the abdomen in an attempt to kill any microscopic cancer cells that might be present on these surfaces.
Drug: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure in which the internal parts of the abdomen are bathed in a warm solution of anti-cancer medications for 90 minutes.
Other Name: HIPEC
- Post Operative Complications [ Time Frame: 90 days following surgery ]Patients will be followed for 90 days following surgery. Postoperative complications will be recorded and graded according to the modified Clavien-Dindo classification.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672865
|United States, California|
|Loma Linda University Cancer Center|
|Loma Linda, California, United States, 92354|
|Principal Investigator:||Maheswari Senthil, MD||Loma Linda University Cancer Center|