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Individualized Chemotherapy Based on BRCA1 and RRM1 mRNA for Advanced Non-small Cell Lung Cancer (NSCLC) (BRAVO)

Primary Purpose

Non-small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Gemcitabine, Docetaxel, CPT-11,Cisplatin

gemcitabine/cisplatin

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Chemotherapy, Individual therapy, RRM1, BRCA1

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent,
Histologically confirmed stage M1a or M1b NSCLC,
Aged over 18 years old,
Measurable disease,
Life expectancy of at least 12 weeks,
No prior chemotherapy or target therapy,
No brain metastases or spinal cord compression,
Less than 10% body weight loss,
ECOG performance status 0-2,
Adequate vital organ function (haematological, renal, hepatic, etc).
Enough tissue for detection of BRCA1 and RRM1 expression.

Exclusion Criteria:

Prior systemic cytotoxic chemotherapy or EGFR TKI therapy,
Positive pregnancy test,
Another active malignancy, other than superficial basal cell and squamous cell or carcinoma in situ of the cervix, within the last 5 years,
Patients with brain metastases or spinal cord compression,
Allergy to gemcitabine, cisplatin, docetaxel, CPT-11,
Any unstable systemic disease including active infection,
No enough tissue for detection of BRCA1 and RRM1

Sites / Locations

Medical Department, Shanghai Pulmonary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Based on expression levels of RRM1 and BRCA1 mRNA，one of the four regimens will be given to each patient: Gemcitabine/cisplatin, Docetaxel/gemcitabine, CPT-11/Cisplatin, docetaxel monotherapy. The chemotherapy will be repeated every 3 week. Dose reduction or interruption for toxicity could take place at any time.

gemcitabine/cisplatin up to 6 cycles or disease progression or intolerable toxicity.

Outcomes

Primary Outcome Measures

Overall response rate

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

Secondary Outcome Measures

Progression free survival

PFS is evaluated in the 24th month since the treatment began

duration of response

evaluated in the 24th month since the treatment began

overall survival

evaluated in the 24th month since the treatment began

safety

evaluated in the 24th month since the treatment began

Quality Of Life

evaluated in the 24th month since the treatment began

Full Information

NCT ID

NCT01424709

First Posted

May 9, 2011

Last Updated

September 23, 2014

Sponsor

Tongji University

1. Study Identification

Unique Protocol Identification Number

NCT01424709

Brief Title

Individualized Chemotherapy Based on BRCA1 and RRM1 mRNA for Advanced Non-small Cell Lung Cancer (NSCLC)

Acronym

BRAVO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Unknown status

Study Start Date

December 2010 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tongji University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Gemcitabine, docetaxel, CPT-11 and cisplatin are effective in 1st line treatment of advanced non-small cell lung cancer (NSCLC). Platinum-based doublets including gemcitabine, docetaxel or CPT-11 are standard 1st regimens. BRCA1 and RRM1 expression levels are reported to be associated with sensitivity of the tumor cells to cytotoxic agents. Some Phase II or III trials did prove feasibility of customized chemotherapy based upon expression levels of one or two biomarkers in the NSCLC patients. The investigators think customized chemotherapy may further improve efficacy of chemotherapy in advanced NSCLC. But there is no randomised trial to compare efficacy of standard chemotherapy with individualized chemotherapy in this setting. So, the investigators plan to initiate this phase II trial to compare efficacy between standard chemotherapy of gemcitabine/cisplatin versus customized chemotherapy in chemonaive NSCLC patients.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

Chemotherapy, Individual therapy, RRM1, BRCA1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Description

gemcitabine/cisplatin up to 6 cycles or disease progression or intolerable toxicity.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine, Docetaxel, CPT-11,Cisplatin

Other Intervention Name(s)

gemcitabine:Gemzar, Docetaxel:Taxotere, CPT-11:Irinotecan

Intervention Description

Intervention Type

Drug

Intervention Name(s)

gemcitabine/cisplatin

Other Intervention Name(s)

gemcitabine:Gemzar

Intervention Description

gemcitabine/cisplatin up to 6 cycles or disease progression or intolerable toxicity.

Primary Outcome Measure Information:

Title

Overall response rate

Description

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

Time Frame

tumor assessment 6-8 weeks after the initiation of chemotherapy

Secondary Outcome Measure Information:

Title

Progression free survival

Description

PFS is evaluated in the 24th month since the treatment began

Time Frame

24 months

Title

duration of response

Description

evaluated in the 24th month since the treatment began

Time Frame

24 months

Title

overall survival

Description

evaluated in the 24th month since the treatment began

Time Frame

24 months

Title

safety

Description

evaluated in the 24th month since the treatment began

Time Frame

24 months

Title

Quality Of Life

Description

evaluated in the 24th month since the treatment began

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent, Histologically confirmed stage M1a or M1b NSCLC, Aged over 18 years old, Measurable disease, Life expectancy of at least 12 weeks, No prior chemotherapy or target therapy, No brain metastases or spinal cord compression, Less than 10% body weight loss, ECOG performance status 0-2, Adequate vital organ function (haematological, renal, hepatic, etc). Enough tissue for detection of BRCA1 and RRM1 expression. Exclusion Criteria: Prior systemic cytotoxic chemotherapy or EGFR TKI therapy, Positive pregnancy test, Another active malignancy, other than superficial basal cell and squamous cell or carcinoma in situ of the cervix, within the last 5 years, Patients with brain metastases or spinal cord compression, Allergy to gemcitabine, cisplatin, docetaxel, CPT-11, Any unstable systemic disease including active infection, No enough tissue for detection of BRCA1 and RRM1

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Caicun Zhou, Ph.D

Organizational Affiliation

Tongji University Affiliated Shanghai Pulmonary Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical Department, Shanghai Pulmonary Hospital

City

Shanghai

ZIP/Postal Code

200433

Country

China

12. IPD Sharing Statement

Learn more about this trial

Individualized Chemotherapy Based on BRCA1 and RRM1 mRNA for Advanced Non-small Cell Lung Cancer (NSCLC)

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