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Navelbine And Radiotherapy in Locally Advanced Lung Cancer (NARLAL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Aarhus University Hospital
Vejle Hospital
Rigshospitalet, Denmark
Aalborg Universitetshospital
Copenhagen University Hospital at Herlev
Information provided by (Responsible Party):
Olfred Hansen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00887783
First received: April 23, 2009
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

This study is an open label randomized multi-centre phase II trial in patients with inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general criteria for curatively intended irradiation. The treatment plan consists of two courses of inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day 1 of the last induction chemotherapy has been given. The patients will be included in the study after completing the induction chemotherapy. Randomization will take place only if an acceptable dose plan can be obtained.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Navelbine
Radiation: irradiation-66 Gy
Radiation: irradiation-60 Gy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Local failure free survival at 9 months after start of radiotherapy [ Time Frame: May 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: May 2012 ] [ Designated as safety issue: Yes ]
  • Local tumour control [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • Overall response rate (CR + PR) [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • Local tumour control at 9 months evaluated by PET-CT [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • Disease free survival [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • Late toxicity [ Time Frame: May 2012 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 114
Study Start Date: May 2009
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)
Drug: Navelbine
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
Other Name: Vinorelbine
Radiation: irradiation-66 Gy
irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)
Active Comparator: A
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)
Drug: Navelbine
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
Other Name: Vinorelbine
Radiation: irradiation-60 Gy
irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887783

Locations
Denmark
Department of Oncology, Aalborg University Hospital
Aalborg, Denmark, 9100
Department of Oncology, Aarhus University Hospital
Aarhus, Denmark, 8000
Depatment of Oncology, Rigshospitalet
Copenhagen, Denmark, 2100
Department of Oncology, Copenhagen University Hospital Herlev
Herlev, Denmark, 2730
Department of Oncology, Odense University Hospital
Odense, Denmark, 5000
Laboratory of Radiation Physics
Odense, Denmark, 5000
Department of Oncology, Vejle Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
Odense University Hospital
Aarhus University Hospital
Vejle Hospital
Rigshospitalet, Denmark
Aalborg Universitetshospital
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Olfred Hansen, MD Odense University Hospital
  More Information

No publications provided

Responsible Party: Olfred Hansen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00887783     History of Changes
Other Study ID Numbers: 09.01
Study First Received: April 23, 2009
Last Updated: February 6, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Odense University Hospital:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Vinorelbine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014