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

Sponsor

Interdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen Krebsgesellschaft (Other)

Overall Status

Completed

CT.gov ID

NCT00335543

Collaborator

(none)

254

Enrollment

Locations

Duration (Months)

14.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

254 participants

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Outcome Measures

Primary Outcome Measures

Median survival []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Innsbruck Universitaetsklinik	Innsbruck	Austria	A-6020
2	Allgemeines Krankenhaus - Universitatskliniken	Vienna	Austria	A-1090
3	Robert Roessle Comprehensive Cancer Center - Charite Campus Buch	Berlin	Germany	D-13125
4	Knappschaft Krankenhaus	Bochum	Germany	D-44892
5	DIAKO Ev. Diakonie Krankenhaus gGmbH	Bremen	Germany	D-28239
6	Krankenhaus Dresden - Friedrichstadt	Dresden	Germany	D-01008
7	Universitaet Erlangen	Erlangen	Germany	D-91054
8	Arbeitsgruppe Lebermetastasen und Tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie	Frankfurt	Germany	60590
9	Klinik am Eichert	Goeppingen	Germany	D-73035
10	Chirurgische Universitaetsklinik	Heidelberg	Germany	D-69120
11	Universitaet Leipzig	Leipzig	Germany	D-04103
12	Staedtisches Klinikum Magdeburg	Magdeburg	Germany	D-39130
13	Klinikum der Universitaet Muenchen - Grosshadern Campus	Munich	Germany	D-81377
14	Klinikum Nuernberg - Klinikum Nord	Nuremberg	Germany	D-90419
15	Klinikum der Universitaet Regensburg	Regensburg	Germany	D-93053
16	Universitaetsklinikum Tuebingen	Tuebingen	Germany	D-72076
17	Kantonsspital - St. Gallen	St. Gallen	Switzerland	CH-9007