Clinical trial NCT02672865: Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer
Official title: Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Locally Advanced Malignant Neoplasm
Gastric Cancer
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Post Operative Complications
timeFrame: 90 days following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Center
state: California
Study officials:
affiliation: Loma Linda University Cancer Center
name: Maheswari Senthil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.