Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis

Malignant Neoplasm of Stomach Clinical Trial

— GASTRIPEC  

Official title:

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158988
• Other study ID #: Gastripec I
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2014
• Est. completion date: June 9, 2021

Study information

• Verified date: July 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with histological proven gastric cancer (including cancer of the esophagogastric junction (AEG)) and synchronous peritoneal carcinomatosis, who fulfill the inclusion and exclusion criteria, can be recruited in this study. There are two treatment groups (A and B). The chemotherapy applied intravenously is the same in both groups and is approved for the treatment of gastric cancer. Patients with negative or unknown HER-2 status will be administered Epirubicin, Oxaliplatin and Capecitabine (EOX). Patients with positive HER-2 status will be treated with Cisplatin, Capecitabine and Trastuzumab (CCT).

The chemotherapy is followed by surgical cytoreduction in both groups. Patients randomized into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion with Mitomycin C and Cisplatin .

Patients in both groups receive 3 cycles of postoperative chemotherapy within 4-12 weeks after the surgical procedure and are followed up for 30 months.

If progress of the tumor is detected the patient will no longer be treated according to the study therapy. Patients of group B may get a HIPEC intervention without surgical cytoreduction if contraindication to the drugs applied can be excluded.

Description:

The objective of the trial is to compare the treatment of patients with peritoneal metastasized gastric cancer including carcinoma of the AEG (Adenocarcinoma of the oesophago-gastric-junction) without evidence of other distant metastases treated with neoadjuvant chemotherapy followed by cytoreduction with intraperitoneal chemoperfusion (HIPEC) and postoperative chemotherapy (Group B) and patients treated with cytoreduction alone after neoadjuvant chemotherapy and postoperative chemotherapy (Group A).

Hypothesis of the trial is that surgical cytoreduction with intraperitoneal chemoperfusion (Group B) is superior to cytoreduction alone (Group A) in terms of overall survival.

The trial is designed as a prospective, randomized, open, multicenter and parallel group study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 9, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histological proved diagnosis of peritoneal metastasized gastric cancer including carcinoma of the AEG No evidence of other distant metastases than peritoneal carcinomatosis with exception of Krukenberg Tumors

• Peritoneal Staging with laparoscopy (or explorative laparotomy) and estimation of Peritoneal Cancer Index (PCI) with the possibility of 80% tumor reduction at cytoreductive surgery

• Karnofsky Index 70% or better

• Written informed consent is obtained prior to commencement of trial treatment

Exclusion Criteria:

• Other than peritoneal metastasis of the gastric cancer incl. AEG and Krukenberg tumors

• Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix

• Any previous chemotherapy or radiotherapy, and any investigational treatment for gastric cancer

• Active systemic infections

• Patients with known interstitial lung disease with New York Heart Association classification > 2

• Serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure

• cardiac arrhythmia

• Uncontrolled hypertension (diastolic blood pressure constantly >100 mm Hg, systolic blood pressure constantly > 180 mm Hg).

• Inadequate bone marrow function at the beginning of the trial, defined as platelet count less than <150 GPT/L or neutrophil granulocyte count less than <1.5 GPT/L

• cardiac function EF < 55%

• Inadequate renal function at the beginning of the trial, defined as GFR less than <60 ml/min

• Inadequate liver function at the beginning of the trial, defined as Bilirubin >1.5 times ULN

• Active vaccination within 6 weeks prior to randomisation

• Active hepatitis B or C infection

• Female patients who are pregnant or breast feeding

• Fertile female patients (defined as women with less than a 12-month elapse after the last menstruation) not using an acceptable form of contraception during the trial

• Missing of capacity to contract

• contraindication to the drugs which are used in the trial

• Participation in another therapeutic clinical trial

• Persons institutionalised due to regulatory actions ore by court order.

Related Conditions & MeSH terms

• Carcinoma
• Malignant Neoplasm of Stomach
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Peritoneal Neoplasms
• Secondary Malignant Neoplasm of Other and Unspecified Sites
• Secondary Malignant Neoplasm of Peritoneum
• Stomach Neoplasms

Intervention

Procedure:
• HIPEC
HIPEC: Mitomycin C: 15 mg/m2 (max. 30 mg/ m2, max. 5 L Perfusion). Cisplatin: 75 mg/m2/L (max. 150 mg/m2, max. 5 L Perfusion). 4-12 weeks after cytoreductive surgery 3 cycles postoperative chemotherapy will be applied.

Locations

Country	Name	City	State
Germany	Klinik für Allgemein-, Visceral-, Gefäß- und ThoraxchirurgieCharité Campus Mitte	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Cancer Aid

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	frequency of toxicity and adverse events	frequency of toxicity and adverse events, visit 1-11 (every 3 weeks) and thereafter every 3 months up to 2.5 years. AE is documented with the date of the begin and the end of the AE and the intensity according to CTCAE V4.0	every 3 weeks) and thereafter every 3 months up to 2.5 years end of study
Other	frequency of necessary secondary surgical procedures and the length of hospitalisation	frequency of necessary secondary surgical procedures and the length of hospitalisation every 6 months up to 2.5 years . The date of the begin and the end is daocumented as well as the reasons	end of study, every 6 months up to 2.5 years
Primary	The primary outcome measure is overall survival	Overall survival from randomisation up to end of study, follow up every 3 months till 2.5 years	Death or 2.5 years
Secondary	30 days complication-rate	30 days complication-rate. Complications are ranked from grade 0-5 according to CTCAE V4.0	30 days postoperative
Secondary	time to progress	time to progress of tumor, follow up every 3 months till 2.5 years	follow up every 3 months till 2.5 years end of study, 2.5 years
Secondary	time to other distant metastases	time to other distant metastases follow up every 3 months till 2.5 years	end of study follow up every 3 months till 2.5 years
Secondary	quality of life	quality of life (EORTC QLQ-30, STO 22). Every 6 months to 2,5 years	Every 6 months to 2,5 years