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NCT Number: NCT00683514

Oral Chemotherapy And Platinum With Radiotherapy Followed Or Not By Consolidation With The Same Chemotherapy In Locally Advanced Non Small Cell Lung Cancer

This is a multicenter, open-label, randomised, phase III study of 2 cycles of oral vinorelbine in combination with cisplatin concurrently with radiotherapy randomised to either two more cycles of consolidation therapy with oral vinorelbine and cisplatin plus Best Supportive Care (BSC) or BSC alone in patients with unresectable locally advanced non small cell lung cancer (NSCLC).

The primary objective is to compare progression-free survival in both arms, the secondary is to evaluate the response rate, overall survival in both arms, to evaluate the safety profile in both arms and to assess quality of life by the LCSS questionnaire.

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Key information

Conditions

NSCLC

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pierre Fabre Pharma GmbH

Freiburg im Breisgau, Jechtinger Str. 13, D-79111, Germany

Who can participate

Healthy volunteers accepted: No

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

Main Inclusion Criteria:

  • Presence of at least one measurable lesion (RECIST criteria)
  • Patients with a Karnofsky Performance Status = or > 80%
  • Adequate pulmonary function, bone marrow, hepatic and renal functions

Main Exclusion Criteria:

  • Patients with NSCLC stage IV, with NSCLC stages I, II, IIIA (except N2), with NSCLC stage IIIB with tumour extent or pleural effusion
  • Symptomatic neuropathy > Grade 1
  • Hearing impairment = or > Grade 2
  • Concomitant/uncontrolled medical disorder
  • Pregnant women

Treatment and study plan

Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)

Drug

q 28 days :

  • 50 mg/m2 oral vinorelbine d1, d8, d15
  • 20 mg/m2/d cisplatin from d1 to d4

Primary outcomes

  1. Assessments of measurable and not measurable lesions been carried out at baseline and every 2 treatment cycles by using RECIST criteria

    Time frame: at baseline and every 2 treatment cycles and Regular Follow Up at 2 months intervals during the 1st year after completion of treatment and then every 3 months until progression of the last evaluable patient

Secondary outcomes

  1. Assessment of measurable and not measurable lesions been carried out at baseline and every 2 treatment cycles by using RECIST criteria, LCSS QOL Questionnaire and Physical Examination

    Time frame: At baseline and every 2 treatment cycles, Regular follow up at 2 months intervals during 1 year and then every 3 months

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Collaborators

  • Pierre Fabre Pharma GmbH

Registry information

Official study title

Oral Vinorelbine And Cisplatin With Concomitant Radiotherapy Followed By Either Consolidation Therapy With Oral Vinorelbine And Cisplatin Plus Best Supportive Care Or Best Supportive Care Alone In Stage III Non Small Cell Lung Cancer (NSCLC), A Randomized Phase III Study

Important dates

Study start
2005
Primary completion
2011
First posted
May 23, 2008
Registry last updated
Oct 4, 2016

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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