Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-02

Study Completion Date

2018-10-03

Brief Summary

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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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Detailed Description

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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.

Conditions

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Locally Advanced Malignant Neoplasm Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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HIPEC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No