Malignant Neoplasm of StomachPhase 3GASTRIPECNCT02158988
Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis
A Phase 3 study testing HIPEC in people with Malignant Neoplasm of Stomach and Secondary Malignant Neoplasm of Peritoneum, run by Charite University, Berlin, Germany at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Neoplasm of Stomach, Secondary Malignant Neoplasm of Peritoneum, Secondary Malignant Neoplasm of Other and Unspecified Sites
- What is being tested?
- HIPEC
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2014to 9 Jun 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Allgemein-, Visceral-, Gefäß- und ThoraxchirurgieCharité Campus Mitte
Berlin, 10117
About this study
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
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 .
Read more
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.
Read the 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.
- Conditions
- Malignant Neoplasm of Stomach, Secondary Malignant Neoplasm of Peritoneum, Secondary Malignant Neoplasm of Other and Unspecified Sites
- Being tested
- HIPEC
- Keywords
- Gastric cancer, cancer of the esophagogastric junction, peritoneal carcinomatosis, hyperthermic intraperitoneal chemotherapy, HIPEC
- Medical subject headings
- Stomach Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPECProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| without HIPEC | No intervention | 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. |
| With HIPEC | Experimental | 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. Receives: Procedure: HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Death or 2.5 years
Secondary outcomes (4)
30 days complication-rate
30 days complication-rate. Complications are ranked from grade 0-5 according to CTCAE V4.0
Measured: 30 days postoperative
time to progress
time to progress of tumor, follow up every 3 months till 2.5 years
Measured: follow up every 3 months till 2.5 years end of study, 2.5 years
time to other distant metastases
time to other distant metastases follow up every 3 months till 2.5 years
Measured: end of study 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
Measured: Every 6 months to 2,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study start1 Mar 2014
- Primary completion1 Oct 2020
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasm of StomachStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intraperitoneal (in the abdominal cavity) chemoperfusion with Mitomycin C and Cisplatin
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Aid
- Responsible party
- Principal investigator, Prof. Dr. med. Beate Rau MBA, Charite University, Berlin, Germany
- Investigators
- Beate Rau, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158988
- Sponsor's protocol ID
- Gastripec I
- Acronym
- GASTRIPEC
- Status last verified
- Jul 2021
- First submitted
- 4 May 2014
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Rau B, Lang H, Koenigsrainer A, Gockel I, Rau HG, Seeliger H, Lerchenmueller C, Reim D, Wahba R, Angele M, Heeg S, Keck T, Weimann A, Topp S, Piso P, Brandl A, Schuele S, Jo P, Pratschke J, Wegel S, Rehders A, Moosmann N, Gaedcke J, Heinemann V, Trips E, Loeffler M, Schlag PM, Thuss-Patience P. Effect of Hyperthermic Intraperitoneal Chemotherapy on Cytoreductive Surgery in Gastric Cancer With Synchronous Peritoneal Metastases: The Phase III GASTRIPEC-I Trial. J Clin Oncol. 2024 Jan 10;42(2):146-156. doi: 10.1200/JCO.22.02867. Epub 2023 Oct 31.
PubMed 37906724
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02158988
- Acronym / sponsor ID
- GASTRIPEC / Gastripec I
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Cancer Aid
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intraperitoneal (in the abdominal cavity) chemoperfusion with Mitomycin C and Cisplatin
| Arm | Type | Receives |
|---|---|---|
| without HIPEC | No intervention | –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. |
| With HIPEC | Experimental | Procedure: HIPECPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIPECHIPEC: 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. | Procedure or surgery | With HIPEC |
Primary outcome
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
4 secondary outcomes
30 days complication-rate
Time frame: 30 days postoperative
time to progress
Time frame: follow up every 3 months till 2.5 years end of study, 2.5 years
time to other distant metastases
Time frame: end of study follow up every 3 months till 2.5 years
quality of life
Time frame: Every 6 months to 2,5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Derived from this study: PubMed 37906724Rau B, Lang H, Koenigsrainer A, Gockel I, Rau HG, Seeliger H, Lerchenmueller C, Reim D, Wahba R, Angele M, Heeg S, Keck T, Weimann A, Topp S, Piso P, Brandl A, Schuele S, Jo P, Pratschke J, Wegel S, Rehders A, Moosmann N, Gaedcke J, Heinemann V, Trips E, Loeffler M, Schlag PM, Thuss-Patience P. Effect of Hyperthermic Intraperitoneal Chemotherapy on Cytoreductive Surgery in Gastric Cancer With Synchronous Peritoneal Metastases: The Phase III GASTRIPEC-I Trial. J Clin Oncol. 2024 Jan 10;42(2):146-156. doi: 10.1200/JCO.22.02867. Epub 2023 Oct 31.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beate Rau, Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HIPEC in people with Malignant Neoplasm of Stomach and Secondary Malignant Neoplasm of Peritoneum, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is overall survival (time frame: Death or 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02158988, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.