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

Primary Purpose

Malignant Neoplasm of Stomach, Secondary Malignant Neoplasm of Peritoneum, Secondary Malignant Neoplasm of Other and Unspecified Sites

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

HIPEC

About this trial

This is an interventional treatment trial for Malignant Neoplasm of Stomach focused on measuring Gastric cancer, cancer of the esophagogastric junction, peritoneal carcinomatosis, hyperthermic intraperitoneal chemotherapy, HIPEC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Klinik für Allgemein-, Visceral-, Gefäß- und ThoraxchirurgieCharité Campus Mitte

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

without HIPEC

With HIPEC

Arm Description

Preoperative chemotherapy 3 cycles, each cycle 21 days. Patients with negative or unknown HER-2 status receive Epirubicin 50 mg/m² infusion (maximum 100mg/d). Oxaliplatin 130 mg/m² infusion (maximum 260 mg/d) and capecitabine oral 625 mg/m² two times a day (maximum 2500 mg/d). Patients with positive HER-2 status receive: Cisplatin : 80 mg/m² infusion (maximum of 160 mg/d). Capecitabine: oral 1000 mg/m2 (two times a day maximum of 4000 mg/d), on day 1-14. Trastuzumab: 8 mg/kg infusion (on cycle 1 and 6 mg/kg on cycle 2 and 3). CRS is performed and 4-12 weeks after CRS 3 cycles of postoperative chemotherapy have to be applied. In case of therapy failure patients will be continued to be treated by the responsible investigator according to his medical status.

Patients will be treated with a preoperative chemotherapy as described for the control group. EOX or CCT depending on the HER-2 status. CRS will be performed 2 to 3 weeks after end of last chemotherapy cycle. HIPEC with mitomycin C and cisplatin either at the time of CRS or a delayed HIPEC within 5-7 days. 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. Patients may get a HIPEC intervention without surgical cytoreduction if contraindication to the drugs can be excluded. In case of therapy failure patients will be continued to be treated by the responsible investigator according to his medical status.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

30 days complication-rate

30 days complication-rate. Complications are ranked from grade 0-5 according to CTCAE V4.0

time to progress

time to progress of tumor, follow up every 3 months till 2.5 years

time to other distant metastases

time to other distant metastases follow up every 3 months till 2.5 years

quality of life

quality of life (EORTC QLQ-30, STO 22). Every 6 months to 2,5 years

Full Information

NCT ID

NCT02158988

First Posted

May 4, 2014

Last Updated

July 28, 2021

Sponsor

Charite University, Berlin, Germany

Collaborators

German Cancer Aid

1. Study Identification

Unique Protocol Identification Number

NCT02158988

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

March 1, 2014 (Actual)

Primary Completion Date

October 1, 2020 (Actual)

Study Completion Date

June 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

Collaborators

German Cancer Aid

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Neoplasm of Stomach, Secondary Malignant Neoplasm of Peritoneum, Secondary Malignant Neoplasm of Other and Unspecified Sites

Keywords

Gastric cancer, cancer of the esophagogastric junction, peritoneal carcinomatosis, hyperthermic intraperitoneal chemotherapy, HIPEC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

intraperitoneal (in the abdominal cavity) chemoperfusion with Mitomycin C and Cisplatin

Masking

None (Open Label)

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

without HIPEC

Arm Type

No Intervention

Arm Description

Arm Title

With HIPEC

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

HIPEC

Intervention Description

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.

Primary Outcome Measure Information:

Title

The primary outcome measure is overall survival

Description

Overall survival from randomisation up to end of study, follow up every 3 months till 2.5 years

Time Frame

Death or 2.5 years

Secondary Outcome Measure Information:

Title

30 days complication-rate

Description

30 days complication-rate. Complications are ranked from grade 0-5 according to CTCAE V4.0

Time Frame

30 days postoperative

Title

time to progress

Description

time to progress of tumor, follow up every 3 months till 2.5 years

Time Frame

follow up every 3 months till 2.5 years end of study, 2.5 years

Title

time to other distant metastases

Description

time to other distant metastases follow up every 3 months till 2.5 years

Time Frame

end of study follow up every 3 months till 2.5 years

Title

quality of life

Description

quality of life (EORTC QLQ-30, STO 22). Every 6 months to 2,5 years

Time Frame

Every 6 months to 2,5 years

Other Pre-specified Outcome Measures:

Title

frequency of toxicity and adverse events

Description

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

Time Frame

every 3 weeks) and thereafter every 3 months up to 2.5 years end of study

Title

frequency of necessary secondary surgical procedures and the length of hospitalisation

Description

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

Time Frame

end of study, every 6 months up to 2.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beate Rau, Prof.

Organizational Affiliation

Charite University, Berlin, Germany

Official's Role

Study Director

Facility Information:

Facility Name

Klinik für Allgemein-, Visceral-, Gefäß- und ThoraxchirurgieCharité Campus Mitte

City

Berlin

ZIP/Postal Code

10117

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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