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NCT Number: NCT01781988

Personalized Therapy in Non-small Cell Lung Cancer

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.

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Key information

Conditions

Lung Cancer Carboplatin Adverse Reaction Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The first affiliated hospital of Guangzhou MC

Guangzhou, Guangdong, 510120, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed non-small cell lung cancer
  • age from 18 years to 75 years
  • ECOG Performance Status no more than 2
  • at least one appraisable lung focus of diameter≥ 10 mm by lung CT
  • Haemoglobin ≥10.0 g/dl, Absolute neutrophil count ≥(ANC) 1.5 x 109/L, platelets ≥100 x 109/L
  • Total bilirubin ≤1.5 x upper limit of normal (ULN)
  • ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
  • Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula)
  • Informed consent should be obtained before treatment.

Exclusion criteria

  • Mixed non-adenocarcinoma cell lung cancer histology
  • Previous treatment for Systemic chemotherapy or local radiotherapy
  • Be allergic to chemotherapy drugs
  • second active primary malignancy or serious concomitant medical disease
  • difficulties with adequate follow-up

Treatment and study plan

carboplatin, gemcitabine , pametrexed

Drug

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Guangzhou Medical University

Other

Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

Registry information

Official study title

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

Acronym: PTINCLC

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Feb 1, 2013
Registry last updated
Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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