Adenocarcinomas of the PancreasPhase 1/2PanHIPECNCT02863471
Study on Hyperthermic Intraperitoneal Chemotherapy After Resection of Pancreascarcinoma
A Phase 1/2 study testing Gemcitabine in people with Adenocarcinomas of the Pancreas, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
In patients with peritoneal metastases of colorectal cancer could be a radical removal of all tumor foci a significantly improved survival compared to a sole systemic chemotherapy are additionally achieved by a hyperthermic intraoperative chemotherapy (HIPEC). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Adenocarcinomas of the Pancreas
- What is being tested?
- Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Oct 2018
- Phase
- Phase 1/2
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years
- Computertomographic (CT) morphologically suspected pancreatic tumor without distant metastases, with the possibility of a macroscopically complete resection residual tumor classification (R) R0 / R1 .
- Histological diagnosis of adenocarcinoma of the pancreas' in the frozen section intraoperatively
- Karnofsky Index > 70
Who cannot join
- Patients who are considered inoperable because of reduced general
- Congestive heart failure New York Heart Association (NYHA) III / IV
- Severe coronary heart disease, non-treatable arrhythmia or nonadjustable hypertension,
- Severe asthma suffering, chronic obstructive pulmonary disease (COPD)
- Renal insufficiency (serum creatinine ≥ 1.5 x of normal, or creatinine clearance <60 milliliter (ml) / minutes (min))
- Patients where the intra-operative frozen section no adenocarcinoma of the pancreas can be demonstrated
Show all 20Show fewer
- Patients suffering from a second malignancy (within 5 years in the study of consent) except basal cell carcinoma and curative treated insitu carcinoma of the cervix
- Distant metastases (M) > 0
- Patients with a contraindication related to the present study
- Allergy or intolerance to the study drug or a substance with chemical similarity to the study medication.
- Patients under legal custodianship or incarcerated patients
- Patients that can not understand the purpose of the study due to mental, intellectual or linguistic problem
- Participation in Clinical Trials or other observation period of competing trials.
- Pregnancy, lactation
- Females of childbearing potential (FCBP) that do not agree
- To utilize two reliable forms of contraception or practice complete abstinence from Simultaneously heterosexual contact for at least 28 days before start of treatment and for at least 28 days after administration of study treatment
- To abstain from breastfeeding during study participation and 6 months after study treatment.
- Males that do not agree
- to use a latex condom during any sexual contact with FCBP during participation in the study and for at least 28 days study following treatment, even if he has undergone a successful vasectomy
- to refrain from donating semen or sperm for at least 28 days after study treatment.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital
Tübingen, Baden-Wurttemberg, 72076
Stefan Beckert, Prof. Dr., +49-7071-2981222, stefan.beckert@med.uni-tuebingen.de
Alfred Königsrainer, Prof. Dr., +49-7071-2986619, alfred.koenigsrainer@med.uni-tuebingen.de
About this study
Official title: Open-label Pilot Phase I / II Study on Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Macroscopically Complete Resection (R0/R1) of Adenocarcinomas of the Pancreas (PanHIPEC)
In patients with peritoneal metastases of colorectal cancer could be a radical removal of all tumor foci a significantly improved survival compared to a sole systemic chemotherapy are additionally achieved by a hyperthermic intraoperative chemotherapy (HIPEC).
Read the detailed description
Despite medical progress in recent years in pancreatic reach the 5-year survival rates even after radical surgical resection only 20%, which is due to high rates of local recurrence and distant metastases in the postoperative course. Due to the anatomical position of the pancreas resections are having a "wide margin" technically almost impossible, so that the tumor on postoperative preparation is often marginal forming. A further possible explanation for the high number of local recurrences, intraoperative tumor cell displacement in question.
In patients with peritoneal metastases of colorectal cancer could be a radical removal of all tumor foci a significantly improved survival compared to a sole systemic chemotherapy are additionally achieved by a hyperthermic intraoperative chemotherapy (HIPEC). Purpose of HIPEC it is to kill any remaining microscopic residual tumor or residual tumor cells free. The aim of the present phase I / II study is therefore to examine the importance of HIPEC in addition to radical resection of ductal pancreatic cancer in terms of mortality and morbidity.
- Conditions
- Adenocarcinomas of the Pancreas
- Being tested
- Gemcitabine
- Keywords
- Pancreas, Adenocarcinoma, Hyperthermic intraperitoneal chemotherapy, HIPEC, Pancreatic surgery, Gemcitabine
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
1000 milligram (mg)/square meters (m2) body surface 60 minutes (min) intraperitoneal hyperthermic lavage
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine | Experimental | 1000 milligram (mg)/ square meter (m²) body surface, intraperitoneal use, unique intraoperative application for 60 minutes Receives: Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 days mortality after macroscopically complete Resection ( R0 / R1 ) of an adenocarcinoma of the pancreas in combined with hyperthermic intraperitoneal chemotherapy (HIPEC)
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Measured: day 30
Secondary outcomes (7)
Nausea
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Measured: day 30
Vomiting
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Measured: day 30
Diarrhea
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Measured: day 30
Stomatitis
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Measured: day 30
Hair loss
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Measured: day 30
Neutrophilia
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Measured: day 30
Thrombocytopenia
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Measured: day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2018 (estimated)
- Study completionOct 2018 (estimated)
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 Adenocarcinomas of the PancreasStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Beckert, Prof. Dr., Principal investigator, University Department of General, Visceral and TransplantSurgery Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863471
- Sponsor's protocol ID
- PanHIPEC
- Acronym
- PanHIPEC
- Status last verified
- Oct 2017
- First submitted
- 8 Aug 2016
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yurttas C, Horvath P, Fischer I, Meisner C, Nadalin S, Konigsrainer I, Konigsrainer A, Beckert S, Loffler MW. A Prospective, Phase I/II, Open-Label Pilot Trial to Assess the Safety of Hyperthermic Intraperitoneal Chemotherapy After Oncological Resection of Pancreatic Adenocarcinoma. Ann Surg Oncol. 2021 Dec;28(13):9086-9095. doi: 10.1245/s10434-021-10187-8. Epub 2021 Jun 15.
PubMed 34131821
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Pilot Phase I / II Study on Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Macroscopically Complete Resection (R0/R1) of Adenocarcinomas of the Pancreas (PanHIPEC)
- ClinicalTrials.gov ID
- NCT02863471
- Acronym / sponsor ID
- PanHIPEC / PanHIPEC
- Conditions
- Adenocarcinomas of the Pancreas
- Keywords
- Pancreas, Adenocarcinoma, Hyperthermic intraperitoneal chemotherapy, HIPEC, Pancreatic surgery, Gemcitabine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 11 Aug 2016 (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.
In patients with peritoneal metastases of colorectal cancer could be a radical removal of all tumor foci a significantly improved survival compared to a sole systemic chemotherapy are additionally achieved by a hyperthermic intraoperative chemotherapy (HIPEC).
Detailed description
Despite medical progress in recent years in pancreatic reach the 5-year survival rates even after radical surgical resection only 20%, which is due to high rates of local recurrence and distant metastases in the postoperative course. Due to the anatomical position of the pancreas resections are having a "wide margin" technically almost impossible, so that the tumor on postoperative preparation is often marginal forming. A further possible explanation for the high number of local recurrences, intraoperative tumor cell displacement in question.
In patients with peritoneal metastases of colorectal cancer could be a radical removal of all tumor foci a significantly improved survival compared to a sole systemic chemotherapy are additionally achieved by a hyperthermic intraoperative chemotherapy (HIPEC). Purpose of HIPEC it is to kill any remaining microscopic residual tumor or residual tumor cells free. The aim of the present phase I / II study is therefore to examine the importance of HIPEC in addition to radical resection of ductal pancreatic cancer in terms of mortality and morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine | Experimental | Drug: Gemcitabine1000 milligram (mg)/ square meter (m²) body surface, intraperitoneal use, unique intraoperative application for 60 minutes |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years
- Computertomographic (CT) morphologically suspected pancreatic tumor without distant metastases, with the possibility of a macroscopically complete resection residual tumor classification (R) R0 / R1 .
- Histological diagnosis of adenocarcinoma of the pancreas' in the frozen section intraoperatively
- Karnofsky Index > 70
Key exclusion criteria (20 listed)
- Patients who are considered inoperable because of reduced general
- Congestive heart failure New York Heart Association (NYHA) III / IV
- Severe coronary heart disease, non-treatable arrhythmia or nonadjustable hypertension,
- Severe asthma suffering, chronic obstructive pulmonary disease (COPD)
- Renal insufficiency (serum creatinine ≥ 1.5 x of normal, or creatinine clearance <60 milliliter (ml) / minutes (min))
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 |
|---|---|---|
| GemcitabineAlso: Gemzar1000 milligram (mg)/square meters (m2) body surface 60 minutes (min) intraperitoneal hyperthermic lavage | Drug | Gemcitabine |
Primary outcome
30 days mortality after macroscopically complete Resection ( R0 / R1 ) of an adenocarcinoma of the pancreas in combined with hyperthermic intraperitoneal chemotherapy (HIPEC)
Time frame: day 30
Safety according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0
7 secondary outcomes
Nausea
Time frame: day 30
Vomiting
Time frame: day 30
Diarrhea
Time frame: day 30
Stomatitis
Time frame: day 30
Hair loss
Time frame: day 30
Neutrophilia
Time frame: day 30
Thrombocytopenia
Time frame: day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Derived from this study: PubMed 34131821Yurttas C, Horvath P, Fischer I, Meisner C, Nadalin S, Konigsrainer I, Konigsrainer A, Beckert S, Loffler MW. A Prospective, Phase I/II, Open-Label Pilot Trial to Assess the Safety of Hyperthermic Intraperitoneal Chemotherapy After Oncological Resection of Pancreatic Adenocarcinoma. Ann Surg Oncol. 2021 Dec;28(13):9086-9095. doi: 10.1245/s10434-021-10187-8. Epub 2021 Jun 15.
- 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.
Stefan Beckert, Prof. Dr. principal investigator
University Department of General, Visceral and TransplantSurgery Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gemcitabine in people with Adenocarcinomas of the Pancreas, 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 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: status not confirmed, as of the sponsor's last update on 31 Oct 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Beckert, Prof. Dr. (+49-7071-2981222, stefan.beckert@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 days mortality after macroscopically complete Resection ( R0 / R1 ) of an adenocarcinoma of the pancreas in combined with hyperthermic intraperitoneal chemotherapy (HIPEC) (time frame: day 30). 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 NCT02863471, 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 31 Oct 2017.