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Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer : a Prospective Study


N/A
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Carcinoma

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Trial Information

Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer : a Prospective Study


Inclusion Criteria:



- Histological diagnosis of non-small-cell lung cancer (NSCLC)

- Obtention of a biopsy of the tumour according to the procedure defined in the
protocol

- NSCLC of any stage to be treated by standard conventional first-line chemotherapy, as
defined in the ELCWP guidelines (www.elcwp.org)

- Presence of at least one assessable lesion

- Availability for participating in the detailed follow-up of the protocol

- Signed informed consent.

- Age above 18 years

Exclusion Criteria:

- Patient who was previously treated with chemotherapy for NSCLC or who has any
contra-indication precluding the administration of conventional chemotherapy for
NSCLC

- NSCLC treated by exclusive surgery or radiotherapy

- A history of prior malignant tumour, except non-melanoma skin cancer or in situ
carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year
disease free interval)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Response rate

Outcome Time Frame:

response will be assessed every 3 cycles of chemotherapy according to WHO criteria

Safety Issue:

Yes

Principal Investigator

Thierry Berghmans, MD

Investigator Role:

Study Chair

Investigator Affiliation:

European Lung Cancer Working Party

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

01082

NCT ID:

NCT00864266

Start Date:

March 2009

Completion Date:

March 2015

Related Keywords:

  • Non Small Cell Lung Carcinoma
  • Non small cell lung carcinoma
  • Chemotherapy
  • Response prediction
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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