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

Pancreatic Cancer Clinical Trial

Official title:

Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335543
• Other study ID #: IAGTDK-70-3046-Ho2
• Secondary ID: CDR0000472206EU-
• Status: Completed
• Phase: Phase 2
• First received: June 8, 2006
• Last updated: August 9, 2013
• Start date: June 2003
• Est. completion date: October 2009

Study information

• Verified date: August 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: October 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• cisplatin

• gemcitabine hydrochloride

Procedure:
• adjuvant therapy

• conventional surgery

• neoadjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Austria	Innsbruck Universitaetsklinik	Innsbruck
Austria	Allgemeines Krankenhaus - Universitatskliniken	Vienna
Germany	Robert Roessle Comprehensive Cancer Center - Charite Campus Buch	Berlin
Germany	Knappschaft Krankenhaus	Bochum
Germany	DIAKO Ev. Diakonie Krankenhaus gGmbH	Bremen
Germany	Krankenhaus Dresden - Friedrichstadt	Dresden
Germany	Universitaet Erlangen	Erlangen
Germany	Arbeitsgruppe Lebermetastasen und Tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie	Frankfurt
Germany	Klinik am Eichert	Goeppingen
Germany	Chirurgische Universitaetsklinik	Heidelberg
Germany	Universitaet Leipzig	Leipzig
Germany	Staedtisches Klinikum Magdeburg	Magdeburg
Germany	Klinikum der Universitaet Muenchen - Grosshadern Campus	Munich
Germany	Klinikum Nuernberg - Klinikum Nord	Nuremberg
Germany	Klinikum der Universitaet Regensburg	Regensburg
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Switzerland	Kantonsspital - St. Gallen	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Interdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen Krebsgesellschaft

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median survival			No
Secondary	3-year survival rate			No
Secondary	R0 resection rate			No
Secondary	Rate of medium and high toxicity events			Yes
Secondary	Rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies			No
Secondary	Rate of different regression gradings in resected tumor specimens			No
Secondary	Quality of life before, during, and after therapy			No