Personalized Therapy in Non-small Cell Lung Cancer

Lung Cancer Clinical Trial

— PTINCLC  

Official title:

The Clinical Study of Personalized Therapy for Non-small Cell Lung Cancer Based on ERCC1/RRM1/TS Expression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781988
• Other study ID #: GZMC12521
• Secondary ID: PT12521
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2013
• Last updated: December 15, 2014
• Start date: June 2009
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carboplatin Adverse Reaction
• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	The first affiliated hospital of Guangzhou MC	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Medical University	The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The disease-free survival	The disease-free survival was measured from the day of tumor resection until tumor recurrence (progression) or death as the end point	Followed up these patients for disease-free survival for 4 years