Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer
Primary Purpose
Locally Advanced Malignant Neoplasm, Gastric Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Malignant Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18-75 with biopsy-proven gastric adenocarcinoma
- Tumor clinically staged T3 or T4 and/or nodes staged clinically positive
- ECOG performance status < 2
Exclusion Criteria:
- Distant metastases
- Peritoneal carcinomatosis
- Synchronous malignancy
- Tumors at the gastroesophageal junction
- Recurrent gastric adenocarcinoma
- Creatinine >/= 1.5
- Bilirubin >/= 2
- INR >/= 2
- Allergy to drugs included in the treatment plan
- Pregnancy
- Contraindication to major surgery
Sites / Locations
- Loma Linda University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HIPEC
Arm Description
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.
Outcomes
Primary Outcome Measures
Post Operative Complications
Patients will be followed for 90 days following surgery. Postoperative complications will be recorded and graded according to the modified Clavien-Dindo classification.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02672865
Brief Title
Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer
Official Title
Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2, 2016 (Actual)
Primary Completion Date
October 3, 2018 (Actual)
Study Completion Date
October 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine safety and feasibility of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with mitomycin and cisplatin in patients with locally advanced gastric cancer undergoing standard surgical resection. Patients will be treated with HIPEC using a single dose of mitomycin 15mg/m2 and cisplatin 50mg/m2 at 41-42 C for 90 minutes, during the definitive surgical resection for gastric cancer. HIPEC will be performed after resection but before anastomosis.
Detailed Description
Treatment Plan:
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.
Outcome Measures:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Malignant Neoplasm, Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIPEC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Other Intervention Name(s)
HIPEC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post Operative Complications
Description
Patients will be followed for 90 days following surgery. Postoperative complications will be recorded and graded according to the modified Clavien-Dindo classification.
Time Frame
90 days following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18-75 with biopsy-proven gastric adenocarcinoma
Tumor clinically staged T3 or T4 and/or nodes staged clinically positive
ECOG performance status < 2
Exclusion Criteria:
Distant metastases
Peritoneal carcinomatosis
Synchronous malignancy
Tumors at the gastroesophageal junction
Recurrent gastric adenocarcinoma
Creatinine >/= 1.5
Bilirubin >/= 2
INR >/= 2
Allergy to drugs included in the treatment plan
Pregnancy
Contraindication to major surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maheswari Senthil, MD
Organizational Affiliation
Loma Linda University Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26811651
Citation
Seshadri RA, Glehen O. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in gastric cancer. World J Gastroenterol. 2016 Jan 21;22(3):1114-30. doi: 10.3748/wjg.v22.i3.1114.
Results Reference
result
PubMed Identifier
21448361
Citation
Suo T, Mahteme H, Qin XY. Hyperthermic intraperitoneal chemotherapy for gastric and colorectal cancer in Mainland China. World J Gastroenterol. 2011 Feb 28;17(8):1071-5. doi: 10.3748/wjg.v17.i8.1071.
Results Reference
result
Learn more about this trial
Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer
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