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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COMPLETED
PHASE2
128 participants
INTERVENTIONAL
2009-06-30
2014-12-31
Brief Summary
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Tailored therapy using these molecular determinants suggested patient benefit in a previously reported phase 2 trial. Here, we designed a study for an individual patient analysis of prospectively accrued patients who were treated with the "personalized therapy" approach versus other standard approaches.
Detailed Description
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Patients who were treated on Trials B were analyzed as the "standard therapy" group. Patients accrued to Trial A were called the "personalized therapy" group. disease free survival (DFS) was estimated using the Kaplan-Meier method.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A.individual therapy
Carboplatin was administrated at an area under the plasma concentration time curve (AUC) of 5 on day 1 every 21 days, while gemcitabine was administrated at a dose of 1250 mg/m2 on day 1 and 8 and pemetrexed was administrated at a dose of 500 mg/m2 on day 1.
carboplatin, gemcitabine , pametrexed
A.individual therapy :enrolled patients with ERCC1 negative tumors who received carboplatin and a third-generation agent (gemcitabine or pametrexed) based on RRM1 or TS expression. If RRM1 protein was negatively expressed in the tumor tissues, gemcitabine was used, whereas pemetrexed was used if RRM1 was positively expressed and TS was negatively expressed.
B.non-individualized therapy :enrolled patients who received carboplatin and a third-generation agent but were not based on ERCC1, RRM1, or TS expression.
B. non-individualized therapy
Carboplatin was administrated at an area under the plasma concentration time curve (AUC) of 5 on day 1 every 21 days, while gemcitabine was administrated at a dose of 1250 mg/m2 on day 1 and 8 and pemetrexed was administrated at a dose of 500 mg/m2 on day 1.
carboplatin, gemcitabine , pametrexed
A.individual therapy :enrolled patients with ERCC1 negative tumors who received carboplatin and a third-generation agent (gemcitabine or pametrexed) based on RRM1 or TS expression. If RRM1 protein was negatively expressed in the tumor tissues, gemcitabine was used, whereas pemetrexed was used if RRM1 was positively expressed and TS was negatively expressed.
B.non-individualized therapy :enrolled patients who received carboplatin and a third-generation agent but were not based on ERCC1, RRM1, or TS expression.
Interventions
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carboplatin, gemcitabine , pametrexed
A.individual therapy :enrolled patients with ERCC1 negative tumors who received carboplatin and a third-generation agent (gemcitabine or pametrexed) based on RRM1 or TS expression. If RRM1 protein was negatively expressed in the tumor tissues, gemcitabine was used, whereas pemetrexed was used if RRM1 was positively expressed and TS was negatively expressed.
B.non-individualized therapy :enrolled patients who received carboplatin and a third-generation agent but were not based on ERCC1, RRM1, or TS expression.
Eligibility Criteria
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Inclusion Criteria
2. age from 18 years to 75 years
3. ECOG Performance Status no more than 2
4. at least one appraisable lung focus of diameter≥ 10 mm by lung CT
5. Haemoglobin ≥10.0 g/dl, Absolute neutrophil count ≥(ANC) 1.5 x 109/L, platelets ≥100 x 109/L
6. Total bilirubin ≤1.5 x upper limit of normal (ULN)
7. ALT and AST \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases
8. Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula)
9. Informed consent should be obtained before treatment.
Exclusion Criteria
2. Previous treatment for Systemic chemotherapy or local radiotherapy
3. Be allergic to chemotherapy drugs
4. second active primary malignancy or serious concomitant medical disease
5. difficulties with adequate follow-up
18 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Guangzhou Medical University
OTHER
Guangzhou Medical University
OTHER
Responsible Party
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Heyuwen
Yuwen He, MD
Principal Investigators
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Jianxing He, Proressor
Role: STUDY_CHAIR
The first affiliated hospital of Guangzhou MC
Locations
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The first affiliated hospital of Guangzhou MC
Guangzhou, Guangdong, China
Countries
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References
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He YW, Zhao ML, Yang XY, Zeng J, Deng QH, He JX. Prognostic value of ERCC1, RRM1, and TS proteins in patients with resected non-small cell lung cancer. Cancer Chemother Pharmacol. 2015 Apr;75(4):861-7. doi: 10.1007/s00280-015-2714-y. Epub 2015 Mar 3.
Other Identifiers
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PT12521
Identifier Type: OTHER
Identifier Source: secondary_id
GZMC12521
Identifier Type: -
Identifier Source: org_study_id