Skip to main content

Laparoscopic HIPEC with Chemoradiation as First Line Treatment in Treating Patients with Local Regional Advanced Gastric Cancer

Trial Status: Active

This phase II trial studies how well hyperthermic intraperitoneal chemotherapy (HIPEC) with chemoradiation works as first line treatment in treating patients with gastric cancer that has spread from its original site of growth to nearby tissues or lymph nodes. Drugs used in chemotherapy, such as mitomycin, paclitaxel, carboplatin, fluorouracil, leucovorin, and oxaliplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving HIPEC with chemoradiation may work better in treating patients with gastric cancer.

Inclusion Criteria

  • Clinical diagnosis of gastric cancer post endoscopic ultrasound (EUS), staging must be T3/T4
  • N0/+, M0. EUS must have been done within 8 weeks of the protocol start (diagnostic laparoscopy)
  • Patient must plan to undergo surgical treatment
  • Performance status - Eastern Cooperative Oncology Group (ECOG) scale of performance status of 0-2
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcl
  • Total bilirubin >= 1.5 mg/dl (Gilbert’s syndrome, then < 3.0)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SPGT]) =< 2.5 X institutional upper limit of normal
  • Creatinine within normal institutional limits (< 1.5 x ULN)
  • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Recommended methods of birth control are: The consistent use of an approved hormonal contraception (birth control pill/patches, rings), an intrauterine device (IUD), contraceptive injection (Depo-Provera), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), sexual abstinence (no sexual intercourse) or sterilization. Some study drugs interact with hormonal contraceptives and make them less effective or they should not be used with the disease/condition under study. If that is the case, delete the hormonal methods listed above and state why they are not recommended while taking part in the study. Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after completion of therapy
  • A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

  • Subjects who have any previous treatment for their cancer
  • Patients with known metastatic disease will be excluded from this study; this includes patients with clinically apparent or suspected metastasis to sites other than lymph nodes or peritoneal surfaces
  • Subjects with early stage gastric cancer (stage T1/T2 N0)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents being used in this study, including but not limited to: carboplatin, taxol, fluorouracil (5-FU), leucovorin, mitomycin C
  • Subjects who have received prior radiation to any portion of the abdominal cavity or pelvis are excluded
  • Subjects who have had prior malignancies, except for cured non-melanoma skin cancer, or curatively treated in situ carcinoma of the cervix, or adequately treated malignancies for which there has been no evidence of activity for more than 3 years
  • Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
  • Subjects with a condition that may interfere with the subjects’ ability to understand the requirements of the study
  • Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C positive patients
  • Patients with active coronary artery disease (defined as unstable angina or a positive cardiac stress test) will be excluded. Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 30 days of enrollment
  • Patients with restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study will be excluded
  • Patients with a history of cerebrovascular disease that would limit study compliance or place the patient at unacceptable risk for participation in the study will be excluded
  • Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study, or places them at an unacceptable risk for participation in the study, will also be excluded
  • Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon
  • Patients with any condition that would preclude the ability to deliver appropriate intraperitoneal (IP) therapy
  • Patients with a life expectancy of less than 12 weeks will be excluded from this study

New York

New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE
Contact: Spiros P Hiotis
Phone: 212-241-0560

PRIMARY OBJECTIVES:

I. To determine the pathological complete response in patients with local regional advanced gastric cancer who are treated with neoadjuvant HIPEC and chemoradiation, at the time of surgical resection.

SECONDARY OBJECTIVES:

I. To determine the overall survival, disease-free survival and peritoneal disease-free survival of gastric cancer patients treated with neoadjuvant HIPEC and chemo radiation prior to surgical resection and adjuvant chemotherapy.

OUTLINE:

Patients undergo diagnostic laparoscopy and receive mitomycin C via HIPEC over 90 minutes. Patients with negative cytology on initial diagnostic laparoscopy or patients with positive cytology on initial diagnostic laparoscopy who convert to negative cytology later receive paclitaxel intravenously (IV) and carboplatin IV on days 1, 8, 15, 22, and 29, and undergo intensity-modulated radiation therapy (IMRT) daily 5 days per week. Eligible patients then undergo subtotal or total gastrectomy and D2 lymphadenectomy.

Adjuvant Chemotherapy: 4-12 weeks after surgery, patients receive fluorouracil IV continuously over 48 hours on days 1-2, leucovorin IV over 2 hours on day 1, and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 2 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Icahn School of Medicine at Mount Sinai

Principal Investigator
Spiros P Hiotis

  • Primary ID 18-1101
  • Secondary IDs NCI-2018-03598
  • Clinicaltrials.gov ID NCT04308837