AzTrials
AzTrials

Pancreatic CancerPhase 2NCT00335543

Gemcitabine, Cisplatin, and Radiation Therapy Followed By Surgery or Surgery Alone in Treating Patients With Localized Pancreatic Cancer That Can Be Removed By Surgery

A Phase 2 study testing cisplatin, gemcitabine hydrochloride and adjuvant therapy in people with Pancreatic Cancer, run by Interdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen Krebsgesellschaft at 17 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
cisplatin, gemcitabine hydrochloride and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
254 participants
Where
17 sitesin 3 countries
Study dates
Jun 2003to Oct 2009
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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreatic head
  • No tumors of the body or tail, as defined by a tumor lying between the left border of the superior mesenteric vein and the left border of the aorta and/or the left border of the aorta and the hilum of the spleen
  • Locally resectable disease by CT scan
  • Major vessels (e.g., portal vein, confluence of mesenteric and splenic vein, superior mesenteric artery, celiac trunk, splenic artery, hepatic artery, or superior mesenteric vein) maximally enclosed ≤ 180° by the tumor
  • No infiltration of extrapancreatic organs except the duodenum
  • No carcinoma of the ampulla of Vater
  • No metastasis
  • No peritoneal carcinoma

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Creatinine clearance > 70 mL/min
  • Creatinine < 1.5 mg/dL
  • Platelet count > 100,000/mm³
  • No liver cirrhosis
  • Not pregnant
  • No New York Heart Association class III or IV heart disease
  • No respiratory insufficiency
  • No grade III or IV cardiac arrhythmias
  • No pathology on EKG
  • No other severe cardiopulmonary disease
  • No HIV infection
  • No other disease that renders the patient unsuitable for one treatment option
  • No other malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or other cancer for which the patient was treated with surgery only and has been in complete remission for ≥ 10 years

PRIOR CONCURRENT THERAPY:

  • At least 3 months since prior participation in another clinical trial
  • No prior or other concurrent treatment for carcinoma of the pancreas

Trial locations and contacts

17 sites in 3 countries.

17 sites in 3 countries

Germany14 sites

  • Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

    Berlin, D-13125

  • Knappschaft Krankenhaus

    Bochum, D-44892

  • DIAKO Ev. Diakonie Krankenhaus gGmbH

    Bremen, D-28239

  • Krankenhaus Dresden - Friedrichstadt

    Dresden, D-01008

  • Universitaet Erlangen

    Erlangen, D-91054

  • Arbeitsgruppe Lebermetastasen und Tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie

    Frankfurt, 60590

  • Klinik am Eichert

    Göppingen, D-73035

  • Chirurgische Universitaetsklinik

    Heidelberg, D-69120

  • Universitaet Leipzig

    Leipzig, D-04103

  • Staedtisches Klinikum Magdeburg

    Magdeburg, D-39130

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Klinikum Nuernberg - Klinikum Nord

    Nuremberg, D-90419

  • Klinikum der Universitaet Regensburg

    Regensburg, D-93053

  • Universitaetsklinikum Tuebingen

    Tübingen, D-72076

Other trials in Germany

Austria2 sites

  • Innsbruck Universitaetsklinik

    Innsbruck, A-6020

  • Allgemeines Krankenhaus - Universitatskliniken

    Vienna, A-1090

Other trials in Austria

Switzerland1 site

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

Other trials in Switzerland

About this study

Official title: Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet know whether giving chemotherapy together with radiation therapy before surgery is more effective than surgery alone in treating pancreatic cancer.

PURPOSE: This randomized phase II trial is studying how well giving gemcitabine and cisplatin together with radiation therapy before surgery works compared to surgery alone in treating patients with localized pancreatic cancer that can be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Determine whether neoadjuvant chemoradiotherapy comprising gemcitabine hydrochloride, cisplatin, and radiotherapy is better than immediate surgery, in terms of median survival, in patients with locally resectable adenocarcinoma of the pancreatic head.

Secondary

  • Compare 3-year survival rate in patients treated with these regimens.
  • Compare R0 resection rate in these patients.
  • Compare the rate of medium and high toxicity events in these patients.
  • Compare the rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies.
  • Compare the rate of different regression gradings in resected tumor specimens.
  • Compare the quality of life of these patients.

OUTLINE: This is a prospective, randomized, controlled, open-label, multicenter study. Patients are stratified according to participating center and staging laparoscopy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 22, and 29. Patients also undergo radiotherapy to the tumor and surrounding lymph nodes 5 days a week for 5 weeks followed by 3 more doses of radiotherapy directly to the tumor. Approximately 6 weeks after finishing chemoradiotherapy, patients with no evidence of disease progression undergo surgery to remove the tumor.
  • Arm II: Patients undergo surgery to remove the tumor. After surgery, all patients receive adjuvant chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at the end of chemotherapy and before surgery (arm I), and then at 6 weeks, 6 months, 12 months, and 24 months after surgery.

After completion of study treatment, patients are followed every 3 months for 2 years and then at 3 years.

PROJECTED ACCRUAL: A total of 254 patients will be accrued for this study.

Keywords
adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median survival

Secondary outcomes (6)

  1. 3-year survival rate

  2. R0 resection rate

  3. Rate of medium and high toxicity events

  4. Rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies

  5. Rate of different regression gradings in resected tumor specimens

  6. Quality of life before, during, and after therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2006 (estimated)
  2. Study startJun 2003
  3. Primary completionJun 2009
  4. Study completionOct 2009

Resources

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
Randomised
Masking
None (open label)
Enrolment
254 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00335543
Sponsor's protocol ID
IAGTDK-70-3046-Ho2
Other IDs
CDR0000472206, EU-20609, ISRCTN78805636
Status last verified
Aug 2009
First submitted
8 Jun 2006
Last updated
12 Aug 2013
Results posted
No

Publications

  • Golcher H, Brunner T, Grabenbauer G, Merkel S, Papadopoulos T, Hohenberger W, Meyer T. Preoperative chemoradiation in adenocarcinoma of the pancreas. A single centre experience advocating a new treatment strategy. Eur J Surg Oncol. 2008 Jul;34(7):756-64. doi: 10.1016/j.ejso.2007.11.012. Epub 2008 Jan 10.

    PubMed 18191528

  • Golcher H, Brunner TB, Witzigmann H, Marti L, Bechstein WO, Bruns C, Jungnickel H, Schreiber S, Grabenbauer GG, Meyer T, Merkel S, Fietkau R, Hohenberger W. Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer: results of the first prospective randomized phase II trial. Strahlenther Onkol. 2015 Jan;191(1):7-16. doi: 10.1007/s00066-014-0737-7. Epub 2014 Sep 25.

    PubMed 25252602

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, gemcitabine hydrochloride and adjuvant therapy in people with Pancreatic Cancer, run by Interdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen Krebsgesellschaft at 17 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Germany, Austria, 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?

Median survival. 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 NCT00335543, which also lists 2 linked publications.

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 12 Aug 2013.

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