A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

— RASTEN  

Official title:

A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717938
• Other study ID #: EudraCT number 2007-006033-14
• Status: Completed
• Phase: Phase 3
• First received: July 16, 2008
• Last updated: August 24, 2017
• Start date: June 2008
• Est. completion date: May 2017

Study information

• Verified date: September 2016
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The endpoint is to investigate if the addition of low molecular heparin - enoxaparin, will result in a significant increase of overall survival in patients with small cell lung cancer, receiving standard chemotherapy.

Description:

Chemotherapy will be given in accordance with local or regional guidelines but shall include a platinum drug + any topoisomerase inhibitor. Within these limits the study will accept different local variants as long as each centre remains consistent to its declared standard chemotherapy regimen. The recommended regimen is carboplatin or cisplatin plus etoposide q3 weeks for 4 cycles but up to 6 cycles is allowed. Local dosages and dose reduction schedules will be used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically or cytologically verified SCLC, all stages

2. WHO performance status 0, 1, 2 or 3

3. Age 18 years or older

4. Intention and feasibility to treat with chemotherapy consisting of platinum + topoisomerase inhibitor.

5. Platelets >100 x109 /L

6. Signed informed consent

7. PK (prothrombin complex) INR and APTT within normal ranges.

Exclusion Criteria:

1. Prior systemic chemotherapy for lung cancer.

2. Concomitant anticoagulation treatment, except for ASA or clopidogrel

3. Active overt bleeding of clinical importance or at high risk (e.g. earlier observed haemorrhage in a brain metastasis, severe coagulopathy as haemophilia, severe liver dysfunction with impaired coagulation, acute peptic ulcer, and within the last 3 months suffered from intracranial haemorrhage, or surgery in the central nervous system).

4. Any other known contraindication for enoxaparine ( e.g. Hypersensitivity against enoxaparine and its derivatives).

5. Pregnancy or breast-feeding

6. Fertile women not using effective contraceptives or men who do not agree to use effective contraception during the treatment period.

7. Treatment with any other investigational agent, or participation in any other clinical trial.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• cisplatinum or carboplatin and e.g.etoposide.
Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Numbers of cycles 4-6 according to local variants. Used drugs=cisplatinum or carboplatin and e.g.etoposide. Treatment will be given every three weeks for 4-6 cycles according to local variants.
• cisplatinum or carboplatin and e.g.etoposide+enoxaparin
Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Numbers of cycles 4-6 according to local variants. In addition to this, subjects will receive daily subcutaneous injections of enoxaparin during chemotherapy treatment.

Locations

Country	Name	City	State
Sweden	Gävle hospital	Gävle
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Helsingborg Hospital	Helsingborg
Sweden	Ryhov Hospital, Jönköping	Jönköping
Sweden	Blekinge Hospital	Karlskrona
Sweden	Central Hospital	Karlstad
Sweden	Central Hospital	Kristianstad
Sweden	University Hospital Linköping	Linköping
Sweden	University Hospital Department of Respiratory Medicine	Lund
Sweden	University Hospital MAS	Malmö
Sweden	University Hospital, Örebro	Örebro
Sweden	Karolinska University Hospital	Stockholm
Sweden	Norrlands University Hospital	Umeå
Sweden	Akademiska hospital Uppsala	Uppsala
Sweden	Central Hospital	Växjö
Sweden	Ystad hospital	Ystad

Sponsors (2)

Lead Sponsor	Collaborator
Lund University Hospital	Sanofi

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant increase of overall survival		At follow up 1 year after treatment
Secondary	Toxicity		During treatment