Clinical trial NCT01781988: Personalized Therapy in Non-small Cell Lung Cancer
Official title: The Clinical Study of Personalized Therapy for Non-small Cell Lung Cancer Based on ERCC1/RRM1/TS Expression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Carboplatin Adverse Reaction
Keywords: lung cancer
gemcitabine
carboplatin
pemetrexed
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Guangzhou Medical University
First posted: 2013-02-01
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The disease-free survival
timeFrame: Followed up these patients for disease-free survival for 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The first affiliated hospital of Guangzhou MC
state: Guangdong
Study officials:
affiliation: The first affiliated hospital of Guangzhou MC
name: Jianxing He, Proressor
role: STUDY_CHAIR
References:
citation: 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.