Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02672865
• Other study ID #: 5150301
• Status: Completed
• Phase: Phase 1
• Start date: February 2, 2016
• Est. completion date: October 3, 2018

Study information

• Verified date: April 2019
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 3, 2018
• Est. primary completion date: October 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Gastric Cancer
• Locally Advanced Malignant Neoplasm
• Neoplasms
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Loma Linda University Cancer Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 days following surgery