PHASE II EVALUATION OF CYTOREDUCTION SURGERY AND HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (CRS/HIPEC) IN GASTRIC CANCER

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBanner Health

About this trial

This is a Phase II treatment study analyzing the role of preoperative chemotherapy, preoperative laparoscopic HIPEC, and gastrectomy with CRS/HIPEC in gastric adenocarcinoma patients with cytology-positive only carcinomatosis, radiologically-occult carcinomatosis, or radiology apparent peritoneal-surface only metastatic disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) Age 18 years and above. There will be no upper age restriction. 2)ECOG performance status ≤ 2. (See Appendix A -ECOG Performance Status Scale). 3)Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.

Leukocytes >= 3,000/uL

Absolute neutrophil count >= 1,500/uL

Platelets >= 60,000/Ul

Disqualifiers

Solid organ metastases (liver, central nervous system, lung). 2) Infections such as pneumonia or wound infections that would preclude protocol therapy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

    Procedure/Surgery

    CRS/HIPEC involves aggressive surgical cytoreduction of all visible and palpable tumors, followed by the synergistic use of heated and high dose chemotherapy to address microscopic residual disease.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To assess improvements in survival in gastric adenocarcinoma patients with occult or apparent carcinomatosis after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

To determine if preoperative laparoscopic HIPEC and chemotherapy followed by cytoreductive surgery (CRS), gastrectomy and HIPEC in patients with peritoneal surface-only metastasis will improve PFS and/or OS from date of diagnosis of metastatic gastric adenocarcinoma

Time frame
From enrollment up to 60 months

Secondary outcomes

1

To study recurrence pattern in patients with recurrence during the study period

Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging.

Time frame
From enrollment up to 60 months

Other outcomes

Sponsors and contacts

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