Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/12/2017 |
| Start Date: | February 2, 2016 |
| End Date: | December 2018 |
| Contact: | Maheswari Senthil, MD |
| Email: | msenthil@llu.edu |
| Phone: | 909-558-4000 |
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.
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.
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.
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.
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
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