Cancer of the Pancreatic HeadPhase 2NCT00490360
Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head
A Phase 2 study testing Gemcitabine / Cisplatin in people with Cancer of the Pancreatic Head, run by University of Zurich at 1 site in Switzerland.
Trial summary
Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Pancreatic Head
- What is being tested?
- Gemcitabine / Cisplatin
- How many people
- 2,007 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2001to May 2007
- 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
- Histologically or cytologically confirmed resectable ductal adenocarcinoma of the pancreatic head
- WHO-performance status 0-2
- Written informed consent
- Discussion in an intrdisciplinary conference
- Exclusion criteria: - Insufficient renal function (calculated creatinin clearance < 60ml(min)
- Insufficient hematologic function (neutrophil count <1'000/ul, platelets < 100'000/ul)
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- Uncorrectable coagulopathy
- Severe cholestasis (bilirubin >100mmol/l)
- Distant metastases in liver, lungs or other organs
- Peritoneal carcinomatosis
- Unresectable tumor (s. 4.2.)
- Contraindication for Whipple procedure
- Uncontrolled infection
- Neurotphil count > °2
- Estimated life experience < 6 months
- HIV Infection
- Severe medical or psychatric comorbidities which interefere with the participation in this trial or the informed consent
- Female patients in child-bearing age without adequate contraception
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Zurich, Department of Surgery
Zurich
About this study
Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head.
Read the detailed description
Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head. Two cycles of chemotherapy are given on day 1 and 15 each. After restaging excludes disease progression, a standard Whipple procedure is performed.
Staging and restaging procedures include abdominal CT, diagnostic laparoscopy, PET/CT, tumor markers (CEA, CA 19-9) and assessment of the quality of life by the QLQ-30.
- Trial with medicinal product
- Conditions
- Cancer of the Pancreatic Head
- Being tested
- Gemcitabine / Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine / CisplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Resectability rate > 70% after restaging
Measured: 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study startOct 2001
- Study completionMay 2007
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 Cancer of the Pancreatic HeadStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490360
- Sponsor's protocol ID
- 21-2001
- Status last verified
- Jun 2007
- First submitted
- 21 Jun 2007
- Last updated
- 22 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Heinrich S, Schafer M, Weber A, Hany TF, Bhure U, Pestalozzi BC, Clavien PA. Neoadjuvant chemotherapy generates a significant tumor response in resectable pancreatic cancer without increasing morbidity: results of a prospective phase II trial. Ann Surg. 2008 Dec;248(6):1014-22. doi: 10.1097/SLA.0b013e318190a6da.
PubMed 19092346
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head
- ClinicalTrials.gov ID
- NCT00490360
- Acronym / sponsor ID
- 21-2001
- Conditions
- Cancer of the Pancreatic Head
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,007 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2001
- Study completion
- May 2007 (actual)
- First posted
- 22 Jun 2007 (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.
Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head.
Detailed description
Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head. Two cycles of chemotherapy are given on day 1 and 15 each. After restaging excludes disease progression, a standard Whipple procedure is performed.
Staging and restaging procedures include abdominal CT, diagnostic laparoscopy, PET/CT, tumor markers (CEA, CA 19-9) and assessment of the quality of life by the QLQ-30.
- Trial with medicinal product
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically or cytologically confirmed resectable ductal adenocarcinoma of the pancreatic head
- WHO-performance status 0-2
- Written informed consent
- Discussion in an intrdisciplinary conference
- Exclusion criteria: - Insufficient renal function (calculated creatinin clearance < 60ml(min)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Gemcitabine / Cisplatin | Drug | – |
Primary outcome
Resectability rate > 70% after restaging
Time frame: 2007
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 22 Jun 2007.
- Derived from this study: PubMed 19092346Heinrich S, Schafer M, Weber A, Hany TF, Bhure U, Pestalozzi BC, Clavien PA. Neoadjuvant chemotherapy generates a significant tumor response in resectable pancreatic cancer without increasing morbidity: results of a prospective phase II trial. Ann Surg. 2008 Dec;248(6):1014-22. doi: 10.1097/SLA.0b013e318190a6da.
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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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
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 Gemcitabine / Cisplatin in people with Cancer of the Pancreatic Head, run by University of Zurich at 1 site in Switzerland.
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 18 inclusion and 0 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 22 Jun 2007. 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 Switzerland. 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 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?
Resectability rate > 70% after restaging (time frame: 2007). 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 NCT00490360, 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 22 Jun 2007.