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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


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
NSCLC

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome 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

Safety Issue:

Yes

Principal Investigator

Marcello RIGGI, Clinical Development Director

Investigator Role:

Study Director

Investigator Affiliation:

Institut de Recherche Pierre Fabre

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

PM 0259 CA 304 J1

NCT ID:

NCT00683514

Start Date:

April 2005

Completion Date:

Related Keywords:

  • NSCLC
  • Untreated locally advanced inoperable stage IIIA or stage IIIB NSCLC amenable to radical radiotherapy to a dose of 66 Gy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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