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Individualized 1st Line Chemotherapy Based on BRCA1 and RRM1 mRNA Expression Levels for Advanced Non-small Cell Lung Cancer


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

Individualized 1st Line Chemotherapy Based on BRCA1 and RRM1 mRNA Expression Levels for Advanced Non-small Cell Lung Cancer


Primary end point:ORR Secondary end point:PFS,OS,safety,QOL,etc.


Inclusion Criteria:



1. Written informed consent,

2. Histologically confirmed stage M1a or M1b NSCLC,

3. Aged over 18 years old,

4. Measurable disease,

5. Life expectancy of at least 12 weeks,

6. No prior chemotherapy or target therapy,

7. No brain metastases or spinal cord compression,

8. Less than 10% body weight loss,

9. ECOG performance status 0-2,

10. Adequate vital organ function (haematological, renal, hepatic, etc).

11. Enough tissue for detection of BRCA1 and RRM1 expression.

Exclusion Criteria:

1. Prior systemic cytotoxic chemotherapy or EGFR TKI therapy,

2. Positive pregnancy test,

3. Another active malignancy, other than superficial basal cell and squamous cell or
carcinoma in situ of the cervix, within the last 5 years,

4. Patients with brain metastases or spinal cord compression,

5. Allergy to gemcitabine, cisplatin, docetaxel, CPT-11,

6. Any unstable systemic disease including active infection,

7. No enough tissue for detection of BRCA1 and RRM1

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Description:

to evaluate ORR during 6-8 weeks after all cycles complete

Outcome Time Frame:

tumor assessment 6-8 weeks after the initiation of chemotherapy

Safety Issue:

No

Principal Investigator

Caicun Zhou, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tongji University Affiliated Shanghai Pulmonary Hospital

Authority:

China: Food and Drug Administration

Study ID:

BRAVO study

NCT ID:

NCT01424709

Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Chemotherapy
  • Individual therapy
  • RRM1
  • BRCA1
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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