Non-small Cell Lung CancerPhase 2BRAVONCT01424709
Individualized Chemotherapy Based on BRCA1 and RRM1 mRNA for Advanced Non-small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Gemcitabine, Docetaxel, CPT-11,Cisplatin and gemcitabine/cisplatin in people with Non-small Cell Lung Cancer, run by Tongji University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Gemcitabine, Docetaxel, CPT-11,Cisplatin and gemcitabine/cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualized 1st Line Chemotherapy Based on BRCA1 and RRM1 mRNA Expression Levels for Advanced Non-small Cell Lung Cancer
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.
Read the detailed description
Primary end point:ORR Secondary end point:PFS,OS,safety,QOL,etc.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Gemcitabine, Docetaxel, CPT-11,Cisplatin, gemcitabine/cisplatin
- Keywords
- Chemotherapy, Individual therapy, RRM1, BRCA1
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine, Docetaxel, CPT-11,CisplatinDrug
Also called gemcitabine:Gemzar, Docetaxel:Taxotere, CPT-11:Irinotecan
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/cisplatinDrug
Also called gemcitabine:Gemzar
gemcitabine/cisplatin up to 6 cycles or disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 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. Receives: Drug: Gemcitabine, Docetaxel, CPT-11,Cisplatin |
| Arm 2 | Active comparator | gemcitabine/cisplatin up to 6 cycles or disease progression or intolerable toxicity. Receives: Drug: gemcitabine/cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
to evaluate ORR during 6-8 weeks after all cycles complete
Measured: tumor assessment 6-8 weeks after the initiation of chemotherapy
Secondary outcomes (5)
Progression free survival
PFS is evaluated in the 24th month since the treatment began
Measured: 24 months
duration of response
evaluated in the 24th month since the treatment began
Measured: 24 months
overall survival
evaluated in the 24th month since the treatment began
Measured: 24 months
safety
evaluated in the 24th month since the treatment began
Measured: 24 months
Quality Of Life
evaluated in the 24th month since the treatment began
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startDec 2010
- Primary completionMay 2014
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caicun Zhou, Tongji University
- Investigators
- Caicun Zhou, Ph.D, Principal investigator, Tongji University Affiliated Shanghai Pulmonary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424709
- Sponsor's protocol ID
- BRAVO study
- Acronym
- BRAVO
- Status last verified
- Sep 2014
- First submitted
- 9 May 2011
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized 1st Line Chemotherapy Based on BRCA1 and RRM1 mRNA Expression Levels for Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01424709
- Acronym / sponsor ID
- BRAVO / BRAVO study
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Chemotherapy, Individual therapy, RRM1, BRCA1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Gemcitabine, Docetaxel, CPT-11,CisplatinBased 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. |
| Arm 2 | Active comparator | Drug: gemcitabine/cisplatingemcitabine/cisplatin up to 6 cycles or disease progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent,
- Histologically confirmed stage M1a or M1b NSCLC,
- Aged over 18 years old,
- Measurable disease,
- Life expectancy of at least 12 weeks,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine, Docetaxel, CPT-11,CisplatinAlso: gemcitabine:Gemzar, Docetaxel:Taxotere, CPT-11:IrinotecanBased 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. | Drug | Arm 1 |
| gemcitabine/cisplatinAlso: gemcitabine:Gemzargemcitabine/cisplatin up to 6 cycles or disease progression or intolerable toxicity. | Drug | Arm 2 |
Primary outcome
Overall response rate
Time frame: tumor assessment 6-8 weeks after the initiation of chemotherapy
to evaluate ORR during 6-8 weeks after all cycles complete
5 secondary outcomes
Progression free survival
Time frame: 24 months
duration of response
Time frame: 24 months
overall survival
Time frame: 24 months
safety
Time frame: 24 months
Quality Of Life
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caicun Zhou, Ph.D principal investigator
Tongji University Affiliated Shanghai Pulmonary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Docetaxel, CPT-11,Cisplatin and gemcitabine/cisplatin in people with Non-small Cell Lung Cancer, run by Tongji University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: tumor assessment 6-8 weeks after the initiation of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.