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

Primary Purpose

Lung Cancer, Carboplatin Adverse Reaction

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
carboplatin, gemcitabine , pametrexed
Sponsored by
Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring lung cancer, gemcitabine, carboplatin, pemetrexed

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The first affiliated hospital of Guangzhou MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A.individual therapy

B. non-individualized therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 24, 2013
Last Updated
December 15, 2014
Sponsor
Guangzhou Medical University
Collaborators
The First Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01781988
Brief Title
Personalized Therapy in Non-small Cell Lung Cancer
Acronym
PTINCLC
Official Title
The Clinical Study of Personalized Therapy for Non-small Cell Lung Cancer Based on ERCC1/RRM1/TS Expression
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Medical University
Collaborators
The First Affiliated Hospital of Guangzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Carboplatin Adverse Reaction
Keywords
lung cancer, gemcitabine, carboplatin, pemetrexed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A.individual therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
B. non-individualized therapy
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
carboplatin, gemcitabine , pametrexed
Intervention Description
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 Outcome Measure Information:
Title
The disease-free survival
Description
The disease-free survival was measured from the day of tumor resection until tumor recurrence (progression) or death as the end point
Time Frame
Followed up these patients for disease-free survival for 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianxing He, Proressor
Organizational Affiliation
The first affiliated hospital of Guangzhou MC
Official's Role
Study Chair
Facility Information:
Facility Name
The first affiliated hospital of Guangzhou MC
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25732635
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.
Results Reference
derived

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Personalized Therapy in Non-small Cell Lung Cancer

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