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FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer, Thromboembolism

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Trial Information

FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer


OBJECTIVES:

Primary

- Determine whether the addition of dalteparin results in improved survival.

Secondary

- Determine venous thrombotic event-free survival and metastasis-free survival.

- Determine serious adverse events in patients treated with this drug.

- Determine the toxicity of this drug in these patients.

- Determine the quality of life, breathlessness, anxiety, and depression in patients
treated with this drug.

- Determine the cost effectiveness and cost utility of this drug.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I (control): Patients receive anticancer treatment considered appropriate by the
local medical team.

- Arm II: Patients receive anticancer treatment considered appropriate by the local
medical team. Beginning before the start of the first definitive anticancer treatment,
patients receive dalteparin subcutaneously daily for up to 24 weeks.

Quality of life, anxiety, depression, and dyspnea are assessed at baseline, at 12 and 24
weeks, and then at 9 and 12 months.

After completion of therapy, patients are followed at 9 months, 1 year, and then every 6
months for at least 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histopathological or cytological diagnosis of primary bronchial carcinoma (small cell
or non-small cell lung cancer) within the past 6 weeks

- No other intrathoracic tumors (e.g., carcinoid tumor, mesothelioma, lymphoma, or lung
metastases from another primary site)

- No clinically apparent brain metastases

PATIENT CHARACTERISTICS:

- ECOG performance status 0-3

- Platelet count ≥ 100,000/mm³

- Serum creatinine ≤ 150 µmol/L

- Willing and able to self-administer dalteparin by daily subcutaneous injection or
have it administered by a caregiver

- Not pregnant or nursing

- Fertile female patients must use effective contraception (if sexually active)

- No hemorrhagic stroke within the past 3 months

- No known bleeding disorder

- No hemoptysis of CTC ≥ grade 2 (i.e., symptomatic hemoptysis requiring medical
intervention)

- No central venous catheter requiring the use of thromboprophylaxis

- No known hypersensitivity to dalteparin, heparin, or other low molecular weight
heparins (e.g., history of confirmed or suspected immunologically mediated
heparin-induced thrombocytopenia; acute gastroduodenal ulcer; or subacute
endocarditis)

- No prior illness likely to interfere with study treatment or comparisons

PRIOR CONCURRENT THERAPY:

- No prior treatment likely to interfere with study treatment or comparisons

- More than 12 months since prior and no concurrent therapeutic anticoagulation

- No concurrent ketorolac (Toradol®)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Overall survival

Principal Investigator

Fergus Macbeth, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Velindre NHS Trust

Authority:

Unspecified

Study ID:

CDR0000561532

NCT ID:

NCT00519805

Start Date:

August 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • Thromboembolism
  • thromboembolism
  • extensive stage small cell lung cancer
  • limited stage small cell lung cancer
  • stage IV non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage I non-small cell lung cancer
  • Lung Neoplasms
  • Thromboembolism

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