A Prospective, Randomised trial Of Simultaneous Pancreatic cancer treatment with Enoxaparin and ChemoTherapy

ISRCTN	ISRCTN02140505
DOI	https://doi.org/10.1186/ISRCTN02140505
Secondary identifying numbers	German Tumour Study Registry (Deutsches KrebsStudienRegister) ID No.: 428; CONKO-004

Submission date: 24/07/2007
Registration date: 21/12/2007
Last edited: 27/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Helmut Oettle
Scientific

Augustenburger Platz 1
Berlin
13353
Germany

Phone	+49 (0)30 450 553 222
Email	helmut.oettle@charite.de

Study information

Study design	Prospective open multi-centr, randomised controlled phase IIb trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A Prospective, Randomised trial Of Simultaneous Pancreatic cancer treatment with Enoxaparin and ChemoTherapy
Study acronym	PROSPECT
Study objectives	To reduce thromboembolic events from 10% to 3% within three months with treatment with Enoxaparin.
Ethics approval(s)	Ethical approval granted from the local ethical committee (Charite - Universitaetsmedizin Berlin Ethik-Kommission) on the 29th March 2004 (ref: 69/2004).
Health condition(s) or problem(s) studied	Pancreatic cancer
Intervention	After stratification according to Karnofsky Performance Status (KPS), kidney function, tumour stage, recurrent disease, primary disease, DVT in the past patients will be randomised to treatment with/without enoxaparin. Patients with KPS greater than 80% and normal kidney function receive gemcitabine 1 g/m^2 (30 minutes), cisplatin 30 mg/m^2 (90 minutes), 5-fluorouracil 750 mg/m^2 (24-hours) and folinic acid 200 mg/m^2 (30 minutes) (GFFC), with/without low molecular weight heparin (LMWH) on days 1 and 8 every three weeks with/without enoxaparin 1 mg/kg daily subcutaneously (sc). Patients with KPS less than 80% and increased creatinine plasma levels (greater than 1.3 mg/dl) receive the current standard therapy (gemcitabine 1 g/m^2 (30 minutes) on days 1, 8 and 15 every four weeks) with/without enoxaparin 1 mg/kg daily sc. After 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy (gemcitabine 1 g/m^2 (30 minutes) on days 1, 8 and 15 every four weeks) with/without enoxaparin 40 mg daily sc.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II/III
Drug / device / biological / vaccine name(s)	Enoxaparin
Primary outcome measure	To reduce thromboembolic events from 10% to 3% within three months (Kaplan Meyer estimation).
Secondary outcome measures	1. Reduction of thromboembolic rate at timepoints 6, 9 and 12 months (Kaplan Meyer estimation) 2. Time to progression 3. Overall survival, progression free survival: Kaplan Meyer Plot (current version of SPSS) 4. Rate of remission: description with tabulations, as percentage of the two treatment groups, duration of remission 5. Toxicity: National Cancer Institute (NCI) Common Toxicity Criteria (CTC) grade differentation, description with tabulations 6. Quality of life: tabulation descriptions, assesment with box-plot (current version of SPSS)
Overall study start date	01/04/2004
Completion date	01/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	540
Total final enrolment	312
Key inclusion criteria	1. Histologically or cytologically proven advanced pancreatic cancer stage Iva, b 2. No previous tumour specific therapy of the main tumor or distant metastases 3. Karnofsky Performance Status (KPS) greater than 50% 4. Measurable disease visible per computed tomography (CT) or magnetic resonance tomography (MRT) not older than 14 days 5. No previous deep vein thrombosis (DVT) of the legs within last two years 6. Leucocytes greater than 3.5 x 10^9/L, platelets greater than 100 x 10^9/L 7. Written informed consent 8. Age of 18 years or more 9. Sufficient contraception up to six months after the end of therapy
Key exclusion criteria	1. Indication for anticoagulation therapy 2. Previous bleeding within two weeks before or increased danger of bleeding 3. Body weight less than 45 kg or greater than 100 kg 4. Pregnant or breastfeeding women 5. Heavy disorders, contradictory with study (as decided by physician) 6. Hyperesthesia against study medication or related drugs 7. Patients with renal failure (creatinine clearance less than 30 ml/min)
Date of first enrolment	01/04/2004
Date of final enrolment	01/04/2009

Locations

Countries of recruitment

Germany

Study participating centre

Augustenburger Platz 1

Berlin
13353
Germany

Sponsor information

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
University/education

Augustenburger Platz 1
Berlin
13353
Germany

Phone	+49 (0)30 450 553 222
Email	lars.roll@charite.de
Website	http://www.charite.de/de
"ROR"	https://ror.org/001w7jn25

Funders

Funder type

Industry

Sanofi-Aventis Deutschland GmbH (Germany)

No information available

Lilly Deutschland GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	05/12/2008		Yes	No
Results article		20/06/2015	27/10/2022	Yes	No

Editorial Notes

27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
21/02/2020: Internal review.