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Completed

NCT Number: NCT02672865

Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Loma Linda University Cancer Center

Loma Linda, California, 92354, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Drug

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 3, 2016
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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