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Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer

Sponsor
Loma Linda University (Other)
Overall Status
Completed
CT.gov ID
NCT02672865
Collaborator
(none)
4
Enrollment
1
Location
1
Arm
32
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer
Actual Study Start Date :
Feb 2, 2016
Actual Primary Completion Date :
Oct 3, 2018
Actual Study Completion Date :
Oct 3, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: HIPEC

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 Names:
  • HIPEC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Post Operative Complications [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients aged 18-75 with biopsy-proven gastric adenocarcinoma

    2. Tumor clinically staged T3 or T4 and/or nodes staged clinically positive

    3. ECOG performance status < 2

    Exclusion Criteria:

    1. Distant metastases

    2. Peritoneal carcinomatosis

    3. Synchronous malignancy

    4. Tumors at the gastroesophageal junction

    5. Recurrent gastric adenocarcinoma

    6. Creatinine >/= 1.5

    7. Bilirubin >/= 2

    8. INR >/= 2

    9. Allergy to drugs included in the treatment plan

    10. Pregnancy

    11. Contraindication to major surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Loma Linda University Cancer Center Loma Linda California United States 92354

    Sponsors and Collaborators

    • Loma Linda University

    Investigators

    • Principal Investigator: Maheswari Senthil, MD, Loma Linda University Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maheswari Senthil, MD, Loma Linda University
    ClinicalTrials.gov Identifier:
    NCT02672865
    Other Study ID Numbers:
    • 5150301
    First Posted:
    Feb 3, 2016
    Last Update Posted:
    Apr 12, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Neoplasms

    Study Results

    No Results Posted as of Apr 12, 2019