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Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer

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ClinicalTrials.gov Identifier: NCT02672865
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Maheswari Senthil, Loma Linda University

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
Locally Advanced Malignant Neoplasm Gastric Cancer 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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 : February 2, 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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 Name: HIPEC




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Maheswari Senthil, MD 909-558-4000 ext 15948 msenthil@llu.edu
Contact: Nikki McCutchan, BS 909-651-5948 nmccutchan@llu.edu

Locations
United States, California
Loma Linda University Cancer Center Recruiting
Loma Linda, California, United States, 92354
Contact: Maheswari Senthil, MD    909-558-4000 ext 15460    msenthil@llu.edu   
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Maheswari Senthil, MD Loma Linda University Cancer Center

Publications of Results:
Responsible Party: Maheswari Senthil, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT02672865     History of Changes
Other Study ID Numbers: 5150301
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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
Fever
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Body Temperature Changes
Signs and Symptoms