Gemcitabine, Cisplatin, and Radiation Therapy Followed By Surgery or Surgery Alone in Treating Patients With Localized Pancreatic Cancer That Can Be Removed By Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Interdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen Krebsgesellschaft
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00335543
First received: June 8, 2006
Last updated: August 4, 2009
Last verified: August 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Median survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 3-year survival rate [ Designated as safety issue: No ]
- R0 resection rate [ Designated as safety issue: No ]
- Rate of medium and high toxicity events [ Designated as safety issue: Yes ]
- Rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies [ Designated as safety issue: No ]
- Rate of different regression gradings in resected tumor specimens [ Designated as safety issue: No ]
- Quality of life before, during, and after therapy [ Designated as safety issue: No ]
| Estimated Enrollment: | 254 |
| Study Start Date: | June 2003 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335543
Locations
| Austria | |
| Innsbruck Universitaetsklinik | Recruiting |
| Innsbruck, Austria, A-6020 | |
| Contact: Dietmar Oefner, MD, MSC 43-512-5042-2580 dietmar.oefner@i-med.ac.at | |
| Allgemeines Krankenhaus - Universitatskliniken | Recruiting |
| Vienna, Austria, A-1090 | |
| Contact: Michael F. X. Gnant, MD 43-1-40-400-5646 michael.gnant@meduniwien.ac.at | |
| Germany | |
| Robert Roessle Comprehensive Cancer Center - Charite Campus Buch | Recruiting |
| Berlin, Germany, D-13125 | |
| Contact: Peter M. Schlag, MD, PhD 49-30-9417-1400 pmschlag@charite.de | |
| Knappschaft Krankenhaus | Recruiting |
| Bochum, Germany, D-44892 | |
| Contact: Wolff Schmiegel, MD 49-234-299-3400 meduni-kkh@ruhr-uni-bochum.de | |
| DIAKO Ev. Diakonie Krankenhaus gGmbH | Recruiting |
| Bremen, Germany, D-28239 | |
| Contact: Karl-Heinz Pflueger, MD 49-421-6102-1481 pfluegerkh@diako-bremen.de | |
| Krankenhaus Dresden - Friedrichstadt | Recruiting |
| Dresden, Germany, D-01008 | |
| Contact: Helmut Witzigmann, MD 49-351-480-1520 | |
| Universitaet Erlangen | Recruiting |
| Erlangen, Germany, D-91054 | |
| Contact: W. Hohenberger, MD 49-9131-853-3201 | |
| Arbeitsgruppe Lebermetastasen und Tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie | Recruiting |
| Frankfurt, Germany, 60590 | |
| Contact: Wolf O. Bechstein, MD 49-69-6031-5251 Wolf.Bechstein@kgu.de | |
| Klinik am Eichert | Recruiting |
| Goeppingen, Germany, D-73035 | |
| Contact: Contact Person 49-7161-64-0 radioonkologie@kae.de | |
| Chirurgische Universitaetsklinik | Recruiting |
| Heidelberg, Germany, D-69120 | |
| Contact: Contact Person 49-6221-566-983 markus.buechler@med.uni-heidelberg.de | |
| Universitaet Leipzig | Recruiting |
| Leipzig, Germany, D-04103 | |
| Contact: J. Hauss, MD 49-341-971-7200 | |
| Staedtisches Klinikum Magdeburg | Recruiting |
| Magdeburg, Germany, D-39130 | |
| Contact: Karsten Ridwelski, MD 49-391-791-4201 karsten.ridwelski@klinikum-magdeburg.de | |
| Klinikum der Universitaet Muenchen - Grosshadern Campus | Recruiting |
| Munich, Germany, D-81377 | |
| Contact: Christiane Y. Bruns, MD 49-89-7095-3730 christiane.burns@med.uni-muenchen.de | |
| Klinikum Nuernberg - Klinikum Nord | Recruiting |
| Nuremberg, Germany, D-90419 | |
| Contact: Jens Koehler, MD 49-911-398-2980 j.koehler@klinikum-nuernberg.de | |
| Klinikum der Universitaet Regensburg | Recruiting |
| Regensburg, Germany, D-93053 | |
| Contact: C. Zuelke, MD 49-941-944-6801 | |
| Universitaetsklinikum Tuebingen | Recruiting |
| Tuebingen, Germany, D-72076 | |
| Contact: Alfred Koenigsrainer, MD 49-7071-298-6620 alfred.koenigsrainer@med.uni-tuebingen.de | |
| Switzerland | |
| Kantonsspital - St. Gallen | Recruiting |
| St. Gallen, Switzerland, CH-9007 | |
| Contact: Lukas Marti, MD 41-71-494-2948 lukas.marti@kssg.ch | |
Sponsors and Collaborators
Interdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen Krebsgesellschaft
Investigators
| Study Chair: | W. Hohenberger, MD | Universitaet Erlangen |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00335543 History of Changes |
| Other Study ID Numbers: | CDR0000472206, IAGTDK-70-3046-Ho2, EU-20609, ISRCTN78805636 |
| Study First Received: | June 8, 2006 |
| Last Updated: | August 4, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the pancreas stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Cisplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 19, 2013