Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC)
NCT ID: NCT01201044
Last Updated: 2010-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2010-01-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gemcitabine, Nedaplatin,BAI plus 3DCRT
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..
3DCRT
non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.
Gemcitabine,Nedaplatin, BAI
Drug: Gemcitabine, Nedaplatin, iV
Gemcitabine, Injection, 1000mg/m2, D1/4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles. BAI
Gemcitabine, Nedaplatin, IV Plus 3DCRT
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.
Gemcitabine, Nedaplatin, iV
Gemcitabine, Injection, 1000mg/m2, D1 \& D7/ 4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles.
3DCRT
non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.
Interventions
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Gemcitabine, Nedaplatin, iV
Gemcitabine, Injection, 1000mg/m2, D1 \& D7/ 4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles.
3DCRT
non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.
3DCRT
non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.
Gemcitabine,Nedaplatin, BAI
Drug: Gemcitabine, Nedaplatin, iV
Gemcitabine, Injection, 1000mg/m2, D1/4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles. BAI
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Third Military Medical University
OTHER
Responsible Party
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The Third Affiliated of the The Third Military Medical University Cancer Center
Locations
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The 3rd Affiliated Hospital of the 3rd Military Hospital
Chongqing, , China
Countries
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Central Contacts
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Facility Contacts
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Yi Li
Role: primary
Other Identifiers
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DO210101
Identifier Type: -
Identifier Source: secondary_id
DO201001
Identifier Type: -
Identifier Source: org_study_id