Carboplatin Adverse Reaction, Lung Cancer
Conditions
Keywords
lung cancer, gemcitabine, carboplatin, pemetrexed
Brief summary
Excision repair cross complementing 1 (ERCC1) ribonucleotide reductase M1 (RRM1) and thymidylate synthase(TS) are molecular determinants that predict sensitivity or resistance to platinum agents 、 gemcitabine and pemetrexed respectively. 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
Patients who had nonsmall- cell lung cancer (NSCLC) performance status of 0/1 were accrued to 2 phase 2 clinical trials Trial A (carboplatin and chemotherapy individuation based on sensitivity marker ), Trial B (carboplatin non-individuation or chemotherapy non-individuation ). 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.
Interventions
DRUGcarboplatin, 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.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed non-small cell lung cancer 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
1. Mixed non-adenocarcinoma cell lung cancer histology 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The disease-free survival | Followed up these patients for disease-free survival for 4 years | The disease-free survival was measured from the day of tumor resection until tumor recurrence (progression) or death as the end point |
Countries
China
Outcome results
None listed