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Register:	ISRCTN
Last refreshed on:	29 July 2019
Main ID:	ISRCTN34802808
Date of registration:	21/12/2006
Prospective Registration:	No
Primary sponsor:	Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Public title:	Adjuvant chemotherapy with gemcitabine versus observation in patients undergoing curative-intent resection of pancreatic cancer: a multicentre randomised controlled trial
Scientific title:	Adjuvant chemotherapy with gemcitabine versus observation in patients undergoing curative-intent resection of pancreatic cancer: a multicentre randomised controlled trial
Date of first enrolment:	01/07/1998
Target sample size:	368
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN34802808
Study type:	Interventional
Study design:	Open multicentre randomised controlled phase III trial (Treatment)
Phase:	Phase III

Countries of recruitment
Austria	Germany

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Helmut Oettle
Address:	Augustenburger Platz 1 13344 Berlin Germany
Telephone:	-
Email:	helmut.oettle@charite.de
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Histologically proven resected pancreatic carcinoma
2. Standard operation
3. No measurable disease
4. No prior chemo- or radiotherapy
5. No active infection
6. Karnofsky performance status minimum 50%
7. Adequate haematologic, renal and hepatic function
8. Cancer antigen 19-9 (CA 19-9), carcinoembryonic antigen (CEA) less than 2.5 x upper limit of normal (ULN)
9. Start with adjuvant therapy within six weeks after resection
10. Written informed consent

Exclusion criteria:
1. Active infection
2. Impaired coagulation (international normalised ratio [INR] and/or activated partial thromboplastin time [aPPT] more than 1.5 x ULN)
3. Transaminases more than 3 x ULN
4. Serum creatinine more than 1.5 x ULN
5. Postoperative tumour markers (CEA/CA19-9) more than 2.5 x ULN
6. History of another malignant disease other than carcinoma in situ of the uterine cervix or adequately treated basal cell carcinoma of the skin
7. Pregnant or breastfeeding women

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Pancreatic cancer
Cancer
Malignant neoplasm of pancreas

Intervention(s)

Patients were randomised, with stratification for resection, T and nodal status, to receive adjuvant chemotherapy with six cycles of gemcitabine day one, eight and 15 every four weeks (Arm A) or observation (Arm B).

Primary Outcome(s)

Disease-free survival (DFS)

Secondary Outcome(s)

1. Overall survival (OS)
2. Toxicity
3. Quality of life

Secondary ID(s)

German Tumour Study Registry (Deutsches KrebsStudienRegister) ID No.: 200

Source(s) of Monetary Support

Lilly Deutschland GmbH (Germany)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Charite - Universitätsmedizin Berlin Ethik-Kommission, 28/11/1997, ref: 143/97

Results

Results available:	Yes
Date Posted:
Date Completed:	31/12/2004
URL:

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