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Completed

NCT Number: NCT00737867

Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer

The purpose of this study is to explore if the combination of vinorelbine and gemcitabine is better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung cancer, in terms of survival, quality of life and need for palliative radiotherapy.

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Key information

Conditions

Advanced Non-Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Øystein Fløtten, Bergen, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-small cell lung cancer stage IIIB or IV
  • Not eligible for radical radiotherapy or surgery
  • WHO performance status 0-2

Exclusion criteria

  • Pregnancy
  • Other clinical active cancer disease
  • ALAT/ALP more than 3 times upper normal limit, bilirubin >1.5 upper limit
  • Bowel disease that causes malabsorption

Treatment and study plan

Vinorelbine

Drug

Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2

Other names: Navelbine® Oral

Gemcitabine

Drug

Day 1: Gemcitabine infusion 1000 mg/m2 Day 8: Gemcitabine infusion 1000 mg/m2

Other names: Gemzar, Gemcitabin

carboplatin

Drug

Day 1: Carboplatin infusion AUC = 5 (Calvert's formula)

Primary outcomes

  1. survival

    Time frame: one year

Secondary outcomes

  1. Health related quality of life (HrQoL)

    Time frame: 3 months

  2. Toxicity

    Time frame: 3 months

  3. Need for palliative radiotherapy

    Time frame: one year

Sponsors and collaborators

Lead sponsor

The Norwegian Lung Cancer Study Group

Network

Registry information

Official study title

Vinorelbine Plus Gemcitabine (VG) Versus Vinorelbine Plus Carboplatin (VC) in Advanced Non-small Cell Lung Cancer. An Open Randomized Multicenter Phase III Trial From Norwegian Lung Cancer Study Group (NLCG)

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Aug 20, 2008
Registry last updated
Apr 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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