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

NCT00335543 | Completed Phase 2

• 4 other identifiers: IAGTDK-70-3046-Ho2CDR0000472206EU-20609ISRCTN78805636
• Study Type: interventional
• Target: 254
• Locations: 3 countries
• Sites: 17

Brief 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. 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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Median survival

Secondary Outcomes (6)

• 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

Interventions

cisplatin DRUG

gemcitabine hydrochloride DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Interdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen Krebsgesellschaft: lead

Study Sites (17)

Innsbruck Universitaetsklinik

Innsbruck, A-6020, Austria

Location

Allgemeines Krankenhaus - Universitatskliniken

Vienna, A-1090, Austria

Location

Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

Berlin, D-13125, Germany

Location

Knappschaft Krankenhaus

Bochum, D-44892, Germany

Location

DIAKO Ev. Diakonie Krankenhaus gGmbH

Bremen, D-28239, Germany

Location

Krankenhaus Dresden - Friedrichstadt

Dresden, D-01008, Germany

Location

Universitaet Erlangen

Erlangen, D-91054, Germany

Location

Arbeitsgruppe Lebermetastasen und Tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie

Frankfurt, 60590, Germany

Location

Klinik am Eichert

Göppingen, D-73035, Germany

Location

Chirurgische Universitaetsklinik

Heidelberg, D-69120, Germany

Location

Universitaet Leipzig

Leipzig, D-04103, Germany

Location

Staedtisches Klinikum Magdeburg

Magdeburg, D-39130, Germany

Location

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, D-81377, Germany

Location

Klinikum Nuernberg - Klinikum Nord

Nuremberg, D-90419, Germany

Location

Klinikum der Universitaet Regensburg

Regensburg, D-93053, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 18191528 RESULT

• 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.

  PMID: 25252602 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cisplatin; Gemcitabine; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• W. Hohenberger, MD

  Universitaet Erlangen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 8, 2006
• First Posted: June 12, 2006
• Study Start: June 1, 2003
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2009
• Last Updated: August 12, 2013

Record last verified: 2009-08

Locations

DE (14); AU (2); CH (1)