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Personalized Therapy in Non-small Cell Lung Cancer (PTINCLC)

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ClinicalTrials.gov Identifier: NCT01781988
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : December 17, 2014
Sponsor:
Collaborator:
The First Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Heyuwen, Guangzhou Medical University

Tracking Information
First Submitted Date  ICMJE January 24, 2013
First Posted Date  ICMJE February 1, 2013
Last Update Posted Date December 17, 2014
Study Start Date  ICMJE June 2009
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2014)
The disease-free survival [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2013)
progression-free survival of Patients [ Time Frame: up to 2 years ]
From treatment beginning,Patients will be followed for up to 2 years.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2013)
disease-free survival of patients [ Time Frame: up to 5 years ]
After treatment beginning, patients will be followed for up to 5 years.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: January 30, 2013)
overall survival of patients [ Time Frame: up to 5 years ]
From treatment beginning, the patients will be followed for up to 5 years.
 
Descriptive Information
Brief Title  ICMJE Personalized Therapy in Non-small Cell Lung Cancer
Official Title  ICMJE The Clinical Study of Personalized Therapy for Non-small Cell Lung Cancer Based on ERCC1/RRM1/TS Expression
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Cancer
  • Carboplatin Adverse Reaction
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: carboplatin, gemcitabine , pametrexed
  • Experimental: 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.
    Intervention: Drug: carboplatin, gemcitabine , pametrexed
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2014)
128
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2013)
200
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01781988
Other Study ID Numbers  ICMJE GZMC12521
PT12521 ( Other Identifier: The First Affiliated Hospital of Guangzhou Medical University )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heyuwen, Guangzhou Medical University
Study Sponsor  ICMJE Guangzhou Medical University
Collaborators  ICMJE The First Affiliated Hospital of Guangzhou Medical University
Investigators  ICMJE
Study Chair: Jianxing He, Proressor The first affiliated hospital of Guangzhou MC
PRS Account Guangzhou Medical University
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP