Non-small Cell Lung CancerDO201001NCT01201044
Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC)
A study testing Gemcitabine, Nedaplatin, iV, 3DCRT and Gemcitabine，Nedaplatin, BAI in people with Non-small Cell Lung Cancer, run by Third Military Medical University at 1 site in China.
Trial summary
The purpose of this study is to investigate the efficacy of BAI Plus 3DCRT in local advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Gemcitabine, Nedaplatin, iV, 3DCRT and Gemcitabine，Nedaplatin, BAI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Dec 2012
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage IIIA\&IIIB NSCLC
- male or female, Age ≥18Years, ≤70Years
- Life expectation of at least 12weeks.
- PS performance 0-2
- Measurable disease according to the Response Evaluation Criteria in Solid Tumours ( RECIST)
Who cannot join
- Patient with prior chemotherapy or radiology for IIIA or IIIB NSCLC
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 3rd Affiliated Hospital of the 3rd Military Hospital
Chongqing
Yi Li, +86-13452081471
YI LI
About this study
Official title: A Randomized, Two Arm Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC)
The purpose of this study is to investigate the efficacy of BAI Plus 3DCRT in local advanced NSCLC.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Gemcitabine, Nedaplatin, iV, 3DCRT, Gemcitabine，Nedaplatin, BAI
- Keywords
- BAI, 3DCRT
- 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, Nedaplatin, iVDrug
Gemcitabine, Injection, 1000mg/m2, D1 \& D7/ 4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles.
3DCRTRadiation
non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.
3DCRTRadiation
non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.
Gemcitabine，Nedaplatin, BAIDrug
Drug: Gemcitabine, Nedaplatin, iV
Gemcitabine, Injection, 1000mg/m2, D1/4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles. BAI
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine, Nedaplatin,BAI plus 3DCRT | Experimental | Gemcitabine(1000mg/m2)，Nedaplatin(60mg/m2),BAI, Day 1/4weeks. 4weeks per cycle. Tumor assessment will be perforemd after 2 cycles. if no PD, patient will be treated with 3DCRTfor 1 month. for patient PD after 3DCRT, complete the study. patient no PD after 3DCRT will receive 2 cycle of chemo with Gemcitabine. Nedaplatin.
then patient will be followed for 1 year.. Receives: Radiation: 3DCRT; Drug: Gemcitabine，Nedaplatin, BAI |
| Gemcitabine, Nedaplatin, IV Plus 3DCRT | Other | Gemcitabine 100mg/m2, D1 \& D8 every 4 weeks Nedaplatin 75mg/m2, D1 every 4 weeks. every 4 weeks per cycle. Tumor assessment will be performed after 2 cycles. if no PD, patient will be treated with 3DCRT for 1 month.
for patient PD after 3DCRT, complete the study. patient no PD after 3DCRT will receive 2 cycle of chemo with Gemcitabine. Nedaplatin.
then patient will be followed for 1 year. Receives: Drug: Gemcitabine, Nedaplatin, iV; Radiation: 3DCRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Regular tumour assessments (based on RECIST criteria) for determining disease response and progression using CT and MRI scans, and overall survival.The primary efficacy variable is progression free survival (PFS), defined as the time between randomisation and the date of first documented disease progression or death from any cause, whichever comes first. Disease progression is defined according to the RECIST criteria.
Measured: every 2 cycles
Secondary outcomes (2)
Overall Survival
after Progressive Disease, patient will be contact every 3 month for the survival information.
Measured: every 3 month after Progressive Disease
Time to Progressive Disease (RECIST Criteria)
Regular tumour assessments (based on RECIST criteria) for determining disease response and progression using CT and MRI scans.Time to Progression (TTP) is defined as the time between randomisation and the date of the first documented disease progression.
Measured: Every 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201044
- Sponsor's protocol ID
- DO201001
- Other IDs
- DO210101
- Acronym
- DO201001
- Status last verified
- Dec 2009
- First submitted
- 24 May 2010
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Two Arm Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT01201044
- Acronym / sponsor ID
- DO201001 / DO201001
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- BAI, 3DCRT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 14 Sep 2010 (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.
The purpose of this study is to investigate the efficacy of BAI Plus 3DCRT in local advanced NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine, Nedaplatin,BAI plus 3DCRT | Experimental | Radiation: 3DCRT, Drug: Gemcitabine，Nedaplatin, BAIGemcitabine(1000mg/m2)，Nedaplatin(60mg/m2),BAI, Day 1/4weeks. 4weeks per cycle. Tumor assessment will be perforemd after 2 cycles. if no PD, patient will be treated with 3DCRTfor 1 month. for patient PD after 3DCRT, complete the study. patient no PD after 3DCRT will receive 2 cycle of chemo with Gemcitabine. Nedaplatin. then patient will be followed for 1 year.. |
| Gemcitabine, Nedaplatin, IV Plus 3DCRT | Other | Drug: Gemcitabine, Nedaplatin, iV, Radiation: 3DCRTGemcitabine 100mg/m2, D1 \& D8 every 4 weeks Nedaplatin 75mg/m2, D1 every 4 weeks. every 4 weeks per cycle. Tumor assessment will be performed after 2 cycles. if no PD, patient will be treated with 3DCRT for 1 month. for patient PD after 3DCRT, complete the study. patient no PD after 3DCRT will receive 2 cycle of chemo with Gemcitabine. Nedaplatin. then patient will be followed for 1 year. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- stage IIIA\&IIIB NSCLC
- male or female, Age ≥18Years, ≤70Years
- Life expectation of at least 12weeks.
- PS performance 0-2
- Measurable disease according to the Response Evaluation Criteria in Solid Tumours ( RECIST)
Key exclusion criteria (1 listed)
- Patient with prior chemotherapy or radiology for IIIA or IIIB NSCLC
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, Nedaplatin, iVGemcitabine, Injection, 1000mg/m2, D1 \& D7/ 4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles. | Drug | Gemcitabine, Nedaplatin, IV Plus 3DCRT |
| 3DCRTnon-PD Patient will be treated with 3DCRT after 2 cycles of chemo. | Radiation | Gemcitabine, Nedaplatin, IV Plus 3DCRT |
| 3DCRTnon-PD Patient will be treated with 3DCRT after 2 cycles of chemo. | Radiation | Gemcitabine, Nedaplatin,BAI plus 3DCRT |
| Gemcitabine，Nedaplatin, BAIDrug: Gemcitabine, Nedaplatin, iV Gemcitabine, Injection, 1000mg/m2, D1/4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles. BAI | Drug | Gemcitabine, Nedaplatin,BAI plus 3DCRT |
Primary outcome
Progression Free Survival
Time frame: every 2 cycles
Regular tumour assessments (based on RECIST criteria) for determining disease response and progression using CT and MRI scans, and overall survival.The primary efficacy variable is progression free survival (PFS), defined as the time between randomisation and the date of first documented disease progression or death from any cause, whichever comes first. Disease progression is defined according to the RECIST criteria.
2 secondary outcomes
Overall Survival
Time frame: every 3 month after Progressive Disease
Time to Progressive Disease (RECIST Criteria)
Time frame: Every 2 cycles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gemcitabine, Nedaplatin, iV, 3DCRT and Gemcitabine，Nedaplatin, BAI in people with Non-small Cell Lung Cancer, run by Third Military Medical 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 5 inclusion and 1 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 14 Sep 2010. 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.
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?
Contact YI LI (+86-113452081471, tumordoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: every 2 cycles). 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 14 Sep 2010.