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Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer (ProPeC)

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ClinicalTrials.gov Identifier: NCT04180761
Recruitment Status : Recruiting
First Posted : November 29, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

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

Condition or disease Intervention/treatment Phase
Gastric Neoplasms Drug: intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Pilot Study to Reduce the Incidence of Peritoneal Carcinoma After Curative Gastrectomy of Gastric Carcinoma or Adenocarcinoma of Gastroesophageal Transition by Hyperthermic Intraperitoneal Chemoperfusion
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Incidence of peritoneal metastases and proportion of patients free from peritoneal metastasis after one year after HIPEC. [ Time Frame: one year ]
    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.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: one year ]
    Overall Survival (OS) measured in years.

  2. Progression-free survival (PFS) [ Time Frame: one year ]
    Progression-free survival (PFS) based on imaging (CT).

  3. Number of participants with treatment-related adverse events as assessed by grading according to CTCAE v5.0 and Clavien-Dindo. [ Time Frame: one year ]

    Expected adverse events (AEs) of particular interest must be recorded from grade ≥ III according to CTCAE v5.0 or postoperative complications according to Clavien-Dindo classification from grade ≥ 3b by AE/ADR reporting.

    Unexpected and expected AEs must be documented and reported as SAE from grade IV according to CTCAE v5.0 or from grade 4-5 according to Clavien-Dindo classification.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180761


Contacts
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Contact: Alfred Königsrainer, MD +49-7071-29- ext 86620 alfred.koenigsrainer@med.uni-tuebingen.de

Locations
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Germany
University Department of General, Visceral and Transplant Surgery Recruiting
Tuebingen, BW, Germany, 72076
Contact: Alfred Königsrainer, MD    +49-7071-29 ext -86620    alfred.koenigsrainer@med.uni-tuebingen.de   
Principal Investigator: Alfred Königsrainer, MD         
Sub-Investigator: Can Yurttas, MD         
Sponsors and Collaborators
University Hospital Tuebingen
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04180761    
Other Study ID Numbers: ProPeC
First Posted: November 29, 2019    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases