- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00335543
Gemcitabine, Cisplatin, and Radiation Therapy Followed By Surgery or Surgery Alone in Treating Patients With Localized Pancreatic Cancer That Can Be Removed By Surgery
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Innsbruck, Austria, A-6020
- Innsbruck Universitaetsklinik
-
Vienna, Austria, A-1090
- Allgemeines Krankenhaus - Universitatskliniken
-
-
-
-
-
Berlin, Germany, D-13125
- Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
-
Bochum, Germany, D-44892
- Knappschaft Krankenhaus
-
Bremen, Germany, D-28239
- DIAKO Ev. Diakonie Krankenhaus gGmbH
-
Dresden, Germany, D-01008
- Krankenhaus Dresden - Friedrichstadt
-
Erlangen, Germany, D-91054
- Universitaet Erlangen
-
Frankfurt, Germany, 60590
- Arbeitsgruppe Lebermetastasen und Tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie
-
Goeppingen, Germany, D-73035
- Klinik am Eichert
-
Heidelberg, Germany, D-69120
- Chirurgische Universitaetsklinik
-
Leipzig, Germany, D-04103
- Universitaet Leipzig
-
Magdeburg, Germany, D-39130
- Staedtisches Klinikum Magdeburg
-
Munich, Germany, D-81377
- Klinikum der Universitaet Muenchen - Grosshadern Campus
-
Nuremberg, Germany, D-90419
- Klinikum Nuernberg - Klinikum Nord
-
Regensburg, Germany, D-93053
- Klinikum der Universitaet Regensburg
-
Tuebingen, Germany, D-72076
- Universitaetsklinikum Tuebingen
-
-
-
-
-
St. Gallen, Switzerland, CH-9007
- Kantonsspital - St. Gallen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Median survival
|
Secondary Outcome Measures
Outcome Measure |
---|
3-year survival rate
|
R0 resection rate
|
Rate of medium and high toxicity events
|
Rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies
|
Rate of different regression gradings in resected tumor specimens
|
Quality of life before, during, and after therapy
|
Collaborators and Investigators
Investigators
- Study Chair: W. Hohenberger, MD, Universitaet Erlangen
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Cisplatin
Other Study ID Numbers
- IAGTDK-70-3046-Ho2
- CDR0000472206 (REGISTRY: PDQ (Physician Data Query))
- EU-20609
- ISRCTN78805636
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Cancer
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CelgeneWithdrawnPancreatic Ductal Adenocarcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
University of NebraskaNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic Cancer | Stage I Pancreatic Cancer | Resectable Pancreatic Carcinoma | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Recurrent Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedPancreatic Adenocarcinoma | Resectable Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer | Poorly Differentiated Malignant Neoplasm | Undifferentiated Pancreatic CarcinomaUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer
-
National Cancer Institute (NCI)CompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
University of Wisconsin, MadisonCompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Fudan UniversityUnknownStage ⅠA Pancreatic Cancer | Stage ⅠB Pancreatic Cancer | Stage ⅡA Pancreatic Cancer | Stage ⅡB Pancreatic CancerChina
-
University of UtahNovartis PharmaceuticalsRecruitingMetastatic Pancreatic Carcinoma | Unresectable Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic CancerUnited States
-
Shanghai Zhongshan HospitalFudan UniversityNot yet recruitingPancreatic Cancer Stage III | Pancreatic Cancer, Stage IB | Pancreatic Cancer, Stage IIA | Pancreatic Cancer, Stage IIBChina
Clinical Trials on radiation therapy
-
NRG OncologyNational Cancer Institute (NCI)RecruitingUnrectable or Locally Recurrent Hepatocellular CarcinomaUnited States
-
University of California, San FranciscoVarian Medical SystemsRecruitingStage IV Anal Cancer AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Metastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Postneoadjuvant Therapy Stage... and other conditionsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedBrain Tumor | Central Nervous System TumorUnited States, Canada, Australia, Puerto Rico, Switzerland, New Zealand
-
Medical College of WisconsinRecruitingHead and Neck CancerUnited States
-
Medical College of WisconsinRecruitingResectable Head and Neck Squamous Cell CarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Completed
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAnn Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Extranodal Marginal Zone LymphomaUnited States
-
Changhai HospitalRecruitingLocalized Prostate CancerChina
-
NYU Langone HealthCompletedBreast CancerUnited States
-
Medical College of WisconsinActive, not recruitingHigh-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB) (SIB)Prostate CancerUnited States