Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

NCT04180761 | Withdrawn Phase 2

• 1 other identifier: ProPeC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effect of a combined therapy with gastrectomy and HIPEC in localized advanced gastric cancer.

Conditions

Gastric Neoplasms

Outcome Measures

Primary Outcomes (1)

• Incidence of peritoneal metastases and proportion of patients free from peritoneal metastasis after one year after HIPEC.

  The primary objective of the study is to estimate the effect of a combined therapy with gastrectomy and HIPEC in localized advanced gastric cancer. The primary target is the incidence of peritoneal metastases in CT and the proportion of patients who after one year are free from peritoneal metastasis. The study is intended to provide planning data for a subsequent Phase III study in the form of an RCT.

  one year

Secondary Outcomes (3)

• Overall Survival (OS)

  one year

• Progression-free survival (PFS)

  one year

• Number of participants with treatment-related adverse events as assessed by grading according to CTCAE v5.0 and Clavien-Dindo.

  one year

Study Arms (1)

HIPEC-Treatment

EXPERIMENTAL

Doxorubicin (15 mg/m²/body surface) Cisplatin (75 mg/m²/body surface) applied as hyperthermic intraperitoneal chemotherapy (HIPEC) at 42.5°C for 60 minutes after the gastrectomy. All drugs used are approved.

Drug: intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)

Interventions

intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) DRUG

single dose application of hyperthermic intraperitoneal chemotherapy (HIPEC) at 42.5°C for 60 minutes after the gastrectomy

HIPEC-Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent of the patient
• Positive lavage cytology in staging laparoscopy
• Intraoperative R0- or R1-gastrectomy (Re-evaluation intraoperative)
• Histologically confirmed locally advanced, resectable Adenocarcinomas of the stomach (incl. AEG II-III): \>cT3 and/or cN+ and cM0 (none existing solid Peritoneal metastases, Re-evaluation intraoperative)
• Neoadjuvant chemotherapy ≥ 2 cycles

You may not qualify if:

• \< 18 years
• Existence of contraindications or contraindications against the study medication
• Uncompensated Heart Failure (NYHA III and IV)
• Severe CHD, medically insufficient treatable cardiac arrhythmias, uncontrolled arterial hypertension
• Serum creatinine ≥ 1.5 x the standard value or a Creatinine clearance \< 60 ml/min/1.73 m2
• Severe pulmonary dysfunction (COPD, PAH), Pulmonary function test confirmed (IVC \< 55 %, DLCO \< 40%)
• malignant secondary tumor disease that persists for \< 5 years (Exception: in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin)
• pregnancy or lactation

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Department of General, Visceral and Transplant Surgery

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 29, 2019
• Study Start: November 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 3, 2025

Record last verified: 2019-11

Locations

DE (1)