Gastric NeoplasmsPhase 2ProPeCNCT04180761
Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
A Phase 2 study testing intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) in people with Gastric Neoplasms, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This study investigates the effect of a combined therapy with gastrectomy and HIPEC in localized advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Neoplasms
- What is being tested?
- intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2019to Sep 2022
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 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%)
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Department of General, Visceral and Transplant Surgery
Tübingen, Baden-Wurttemberg, 72076
About this study
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
This study investigates the effect of a combined therapy with gastrectomy and HIPEC in localized advanced gastric cancer.
Read the 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.
- Conditions
- Gastric Neoplasms
- Being tested
- intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)Drug
single dose application of hyperthermic intraperitoneal chemotherapy (HIPEC) at 42.5°C for 60 minutes after the gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| HIPEC-Treatment | Experimental | 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. Receives: Drug: intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of peritoneal metastases and proportion of patients free from peritoneal metastasis after one year after HIPEC.
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.
Measured: one year
Secondary outcomes (3)
Overall Survival (OS)
Overall Survival (OS) measured in years.
Measured: one year
Progression-free survival (PFS)
Progression-free survival (PFS) based on imaging (CT).
Measured: one year
Number of participants with treatment-related adverse events as assessed by grading according to CTCAE v5.0 and Clavien-Dindo.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study startNov 2019 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: No partecipants Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180761
- Sponsor's protocol ID
- ProPeC
- Acronym
- ProPeC
- Status last verified
- Nov 2019
- First submitted
- 7 Nov 2019
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04180761
- Acronym / sponsor ID
- ProPeC / ProPeC
- Conditions
- Gastric Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No partecipants Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 29 Nov 2019 (actual)
- 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.
This study investigates the effect of a combined therapy with gastrectomy and HIPEC in localized advanced gastric cancer.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIPEC-Treatment | Experimental | Drug: intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- < 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
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 |
|---|---|---|
| intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)single dose application of hyperthermic intraperitoneal chemotherapy (HIPEC) at 42.5°C for 60 minutes after the gastrectomy | Drug | HIPEC-Treatment |
Primary outcome
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.
3 secondary outcomes
Overall Survival (OS)
Time frame: one year
Progression-free survival (PFS)
Time frame: one year
Number of participants with treatment-related adverse events as assessed by grading according to CTCAE v5.0 and Clavien-Dindo.
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) in people with Gastric Neoplasms, run by University Hospital Tuebingen 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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 3 Apr 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of peritoneal metastases and proportion of patients free from peritoneal metastasis after one year after HIPEC. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2025.