Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
Keywords
Abstract
Description
An operation and the constant further development of the surgical techniques can not always prevent the recurrence of a tumor of the stomach or the transition from the esophagus to the stomach. As reason for this recurrence, the investigators assume that the tumor was already present at the time of the surgery and has crossed the boundaries of the stomach or free tumor cells are located in the peritoneal cavity, even if they can't be found with the bare eye or imaging methods. Such free tumor cells have the possibility of developing metastases within the abdominal cavity.
An innovative local treatment method is being tested in Tübingen and applied to remove any remaining free tumor cells or very small and invisible residual tumors. These free tumor cells can be determined prior to the start of treatment by peritoneal endoscopy (diagnostic laparoscopy). If these can be identified by lavage of the abdominal cavity there is an increased risk for the development of peritoneal metastases. Therefore, in patients with detected free tumor cells in the lavage water of the abdominal cavity, after the removal of the stomach, should be used once a chemotherapy in the abdominal cavity, which is warmer than the body (intraoperative hyperthermic chemotherapy, HIPEC). In this study the investigators want to demonstrate, that the single administration of intraoperative HIPEC with cisplatin and doxorubicin in addition to routine surgery delays the onset of peritoneal metastases and the additional therapy with its low risks is reasonable.
Dates
| Last Verified: | 10/31/2019 |
| First Submitted: | 11/06/2019 |
| Estimated Enrollment Submitted: | 11/25/2019 |
| First Posted: | 11/28/2019 |
| Last Update Submitted: | 11/25/2019 |
| Last Update Posted: | 11/28/2019 |
| Actual Study Start Date: | 10/31/2019 |
| Estimated Primary Completion Date: | 02/28/2022 |
| Estimated Study Completion Date: | 08/31/2022 |
Condition or disease
Intervention/treatment
Drug: HIPEC-Treatment
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: HIPEC-Treatment 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: HIPEC-Treatment single dose application of hyperthermic intraperitoneal chemotherapy (HIPEC) at 42.5°C for 60 minutes after the gastrectomy |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - 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 Exclusion Criteria: - < 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) - Participation in other interventional studies that at the time of the ProPeC study inclusion, still are not finished - pregnancy or lactation |
Outcome
Primary Outcome Measures
1. Incidence of peritoneal metastases and proportion of patients free from peritoneal metastasis after one year after HIPEC. [one year]
Secondary Outcome Measures
1. Overall Survival (OS) [one year]
2. Progression-free survival (PFS) [one year]
3. Number of participants with treatment-related adverse events as assessed by grading according to CTCAE v5.0 and Clavien-Dindo. [one year]
