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Trial record 19 of 42 for:    Malignant Hyperthermia 5

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

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ClinicalTrials.gov Identifier: NCT02158988
Recruitment Status : Active, not recruiting
First Posted : June 9, 2014
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
German Cancer Aid
Information provided by (Responsible Party):
Prof. Dr. med. Beate Rau MBA, Charite University, Berlin, Germany

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.


Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Stomach Secondary Malignant Neoplasm of Peritoneum Secondary Malignant Neoplasm of Other and Unspecified Sites Procedure: HIPEC Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: intraperitoneal (in the abdominal cavity) chemoperfusion with Mitomycin C and Cisplatin
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
No Intervention: without HIPEC

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.

Experimental: With HIPEC

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.

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.





Primary Outcome Measures :
  1. The primary outcome measure is overall survival [ Time Frame: Death or 2.5 years ]
    Overall survival from randomisation up to end of study, follow up every 3 months till 2.5 years


Secondary Outcome Measures :
  1. 30 days complication-rate [ Time Frame: 30 days postoperative ]
    30 days complication-rate. Complications are ranked from grade 0-5 according to CTCAE V4.0

  2. time to progress [ Time Frame: follow up every 3 months till 2.5 years end of study, 2.5 years ]
    time to progress of tumor, follow up every 3 months till 2.5 years

  3. time to other distant metastases [ Time Frame: end of study follow up every 3 months till 2.5 years ]
    time to other distant metastases follow up every 3 months till 2.5 years

  4. quality of life [ Time Frame: Every 6 months to 2,5 years ]
    quality of life (EORTC QLQ-30, STO 22). Every 6 months to 2,5 years


Other Outcome Measures:
  1. frequency of toxicity and adverse events [ Time Frame: every 3 weeks) and thereafter every 3 months up to 2.5 years end of study ]
    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

  2. frequency of necessary secondary surgical procedures and the length of hospitalisation [ Time Frame: end of study, every 6 months up to 2.5 years ]
    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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02158988


Locations
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Germany
Klinik für Allgemein-, Visceral-, Gefäß- und ThoraxchirurgieCharité Campus Mitte
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
German Cancer Aid
Investigators
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Study Director: Beate Rau, Prof. Charite University, Berlin, Germany

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Responsible Party: Prof. Dr. med. Beate Rau MBA, Prof., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02158988     History of Changes
Other Study ID Numbers: Gastripec I
First Posted: June 9, 2014    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Prof. Dr. med. Beate Rau MBA, Charite University, Berlin, Germany:
Gastric cancer
cancer of the esophagogastric junction
peritoneal carcinomatosis
hyperthermic intraperitoneal chemotherapy
HIPEC
Additional relevant MeSH terms:
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Neoplasm Metastasis
Stomach Neoplasms
Carcinoma
Peritoneal Neoplasms
Neoplasms, Second Primary
Neoplasms
Neoplastic Processes
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Peritoneal Diseases
Cisplatin
Mitomycins
Mitomycin
Antineoplastic Agents
Antibiotics, Antineoplastic
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors