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Induction Chemotherapy With Carboplatin and Navelbine Oral(R) Followed by Concomitant Navelbine Oral(R) and Irradiation in Local-regionally Advanced Non-small Cell Lung Cancer. A Randomized Phase II Study.


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

Induction Chemotherapy With Carboplatin and Navelbine Oral(R) Followed by Concomitant Navelbine Oral(R) and Irradiation in Local-regionally Advanced Non-small Cell Lung Cancer. A Randomized Phase II Study.


Inclusion Criteria:



- Age ≥18 years

- Patients with histologically or cytologically documented diagnosis of locally
advanced NSCLC stage IIB to IIIB without pleural effusion

- Performance status 0-1 on the ECOG scale

- Weight loss ≤10% during the last 6 months

- Adequate lung function measured as FEV1 ≥1.0

- Neutrophile count ≥1.5 x 109/L and platelet count ≥100 x 109/L

- Serum bilirubin ≤1.5 upper limit of normal (ULN)

- ALAT ≤2 x ULN

- Able to comply with study and follow-up procedures

- Patients with reproductive potential must use effective contraception

- Written (signed) informed consent to participate in the study

Exclusion Criteria:

- Any unstable systemic disease (including active infection, unstable angina,
congestive heart failure, severe hepatic, renal, or metabolic disease)

- Any other active malignancies within 5 years (except for adequately treated carcinoma
in situ of the cervix or basal or squamous cell skin cancer)

- Prior chemotherapy for lung cancer, including neo- and adjuvant chemotherapy

- Inability to take oral medication, or requirement of intravenous alimentation

- Active peptic ulcer disease

- Nursing mothers

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Local failure free survival at 9 months after start of radiotherapy

Outcome Time Frame:

May 2012

Safety Issue:

No

Principal Investigator

Olfred Hansen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Odense University Hospital

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

09.01

NCT ID:

NCT00887783

Start Date:

May 2009

Completion Date:

May 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Induction chemotherapy
  • Non-small cell lung cancer
  • Randomized phase II study
  • Navelbine Oral (R)
  • 3D-conformal radiotherapy
  • Chemo-radiotherapy
  • Local-regionally advanced non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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