Gastric CancerPhase 2/3HIPECStomachNCT01683864
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
A Phase 2/3 study testing positive cytology with HIPEC in people with Gastric Cancer and Peritoneal Carcinomatosis, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Peritoneal Carcinomatosis
- What is being tested?
- positive cytology with HIPEC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to May 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically proven gastric adenocarcinoma: uT1,uT2, uT3, Nx, M0
- No prior chemotherapy
- Patients of full age, independent of gender ECOG ≤ 2
- No dissemination of the tumor confirmed by CT of the lung and the abdomen.
- Signed Consent form of the Patient agreeing to investigations
- Leucocytes > 3.000/µl
Show all 10Show fewer
- Thrombocytes > 100.000/µl
- Creatinine ≤ 1.5mg/dl and or Clearance > 60 ml/min
- informed consent of the patient
- normal ejection-fraction of the heart
Who cannot join
- Dissemination of the tumor or non-resectable primary tumor
- Malignant secondary disease < 5 years in the past (Exception: in-situ-carcinoma of the cervix and appropriately treated basal cell carcinoma of the skin)
- Patient not of full age
- Inflammatory chronic bowel disease
- Inclusion of the patient in a different study
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
Read the detailed description
The gastric carcinoma is one of the four most common tumors occurring worldwide. The advanced phase is characterized by metastasis and poses a very poor prognosis for survival. In 20%-30% of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to metastases in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis and its five-year survival rate is less than 2%. Even after R0 resection of a localized gastric carcinoma the five-year survival rate is only 40%, not least of all because relapses in the form of peritoneal metastases are a common occurrence.
Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which stands in strong contrast to the 40% risk for patients with negative cytology.
In the study presented here (group A) therapeutic hyperthermic intraperitoneal chemoperfusion (HIPEC, in the literature also known as HIIC (heated intraoperative intraperitoneal chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c and cisplatin will be administered following gastrectomy in patients with a gastric carcinoma with free tumor cells in cytology diagnosed in the preoperative laparoscopy in comparison to (group B) solely gastrectomy in patients with a gastric carcinoma and also with free tumor cells diagnosed in cytology in the preoperative laparoscopy.
A randomization will be performed between group A and B. Patients with gastric carcinoma (TNM Stage ≥ T2<T4) without proven metastases (TNM stage M0), with and without involved regional lymph nodes (TNM stage +N/-N) and positive cytology in preoperative abdominal lavage will be included. Exclusion criteria are extended disease or inoperable tumor.
This study is already permitted by the local ethic commission and the German Federal Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code: HIPEC_Stomach) and was initiated in August 2012.
- Conditions
- Gastric Cancer, Peritoneal Carcinomatosis
- Being tested
- positive cytology with 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.
positive cytology with HIPECDrug
Also called mytomycin and cisplatin
HIPEC with mytomycin and cisplatin
| Study group | Role | What they receive |
|---|---|---|
| positive cytology with HIPEC | Experimental | gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative Receives: Drug: positive cytology with HIPEC |
| positive cytology without HIPEC | No intervention | gastric cancer cytology positive without HIPEC |
| negative cytology without HIPEC | No intervention | gastric cancer with negative cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal Carcinosis Free Survival
Three patients were enrolled in the study. No study results because no patient has received study drug.
Measured: 5 Years
Disease Free Survival
No study results because no patient has received study drug.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfred Königsrainer, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683864
- Sponsor's protocol ID
- 2011-004405-25
- Acronym
- HIPECStomach
- Status last verified
- Oct 2016
- First submitted
- 6 Sep 2012
- Last updated
- 30 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
- ClinicalTrials.gov ID
- NCT01683864
- Acronym / sponsor ID
- HIPECStomach / 2011-004405-25
- Conditions
- Gastric Cancer, Peritoneal Carcinomatosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Sep 2012 (estimated)
- Results
- Posted 30 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
Detailed description
The gastric carcinoma is one of the four most common tumors occurring worldwide. The advanced phase is characterized by metastasis and poses a very poor prognosis for survival. In 20%-30% of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to metastases in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis and its five-year survival rate is less than 2%. Even after R0 resection of a localized gastric carcinoma the five-year survival rate is only 40%, not least of all because relapses in the form of peritoneal metastases are a common occurrence.
Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which stands in strong contrast to the 40% risk for patients with negative cytology.
In the study presented here (group A) therapeutic hyperthermic intraperitoneal chemoperfusion (HIPEC, in the literature also known as HIIC (heated intraoperative intraperitoneal chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c and cisplatin will be administered following gastrectomy in patients with a gastric carcinoma with free tumor cells in cytology diagnosed in the preoperative laparoscopy in comparison to (group B) solely gastrectomy in patients with a gastric carcinoma and also with free tumor cells diagnosed in cytology in the preoperative laparoscopy.
A randomization will be performed between group A and B. Patients with gastric carcinoma (TNM Stage ≥ T2<T4) without proven metastases (TNM stage M0), with and without involved regional lymph nodes (TNM stage +N/-N) and positive cytology in preoperative abdominal lavage will be included. Exclusion criteria are extended disease or inoperable tumor.
This study is already permitted by the local ethic commission and the German Federal Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code: HIPEC_Stomach) and was initiated in August 2012.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| positive cytology with HIPEC | Experimental | Drug: positive cytology with HIPECgastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative |
| positive cytology without HIPEC | No intervention | –gastric cancer cytology positive without HIPEC |
| negative cytology without HIPEC | No intervention | –gastric cancer with negative cytology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven gastric adenocarcinoma: uT1,uT2, uT3, Nx, M0
- No prior chemotherapy
- Patients of full age, independent of gender ECOG ≤ 2
- No dissemination of the tumor confirmed by CT of the lung and the abdomen.
- Signed Consent form of the Patient agreeing to investigations
Key exclusion criteria (6 listed)
- Dissemination of the tumor or non-resectable primary tumor
- Malignant secondary disease < 5 years in the past (Exception: in-situ-carcinoma of the cervix and appropriately treated basal cell carcinoma of the skin)
- Patient not of full age
- Inflammatory chronic bowel disease
- Inclusion of the patient in a different study
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 |
|---|---|---|
| positive cytology with HIPECAlso: mytomycin and cisplatinHIPEC with mytomycin and cisplatin | Drug | positive cytology with HIPEC |
Primary outcome
Peritoneal Carcinosis Free Survival
Time frame: 5 Years
Three patients were enrolled in the study. No study results because no patient has received study drug.
Disease Free Survival
Time frame: 5 years
No study results because no patient has received study drug.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Alfred Königsrainer, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing positive cytology with HIPEC in people with Gastric Cancer and Peritoneal Carcinomatosis, 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 10 inclusion and 6 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: stopped early, as of the sponsor's last update on 30 Jan 2018. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 30 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Peritoneal Carcinosis Free Survival (time frame: 5 Years). The study lists 2 primary outcomes in all. 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 30 Jan 2018.