Lung CancerPhase 2PTINCLCNCT01781988
Personalized Therapy in Non-small Cell Lung Cancer
A Phase 2 study testing carboplatin, gemcitabine , pametrexed in people with Lung Cancer and Carboplatin Adverse Reaction, run by Guangzhou Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Carboplatin Adverse Reaction
- What is being tested?
- carboplatin, gemcitabine , pametrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of Guangzhou MC
Guangzhou, Guangdong, 510120
About this study
Official title: The Clinical Study of Personalized Therapy for Non-small Cell Lung Cancer Based on ERCC1/RRM1/TS Expression
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.
Read the 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.
- Conditions
- Lung Cancer, Carboplatin Adverse Reaction
- Being tested
- carboplatin, gemcitabine , pametrexed
- Keywords
- lung cancer, gemcitabine, carboplatin, pemetrexed
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatin, gemcitabine , pametrexedDrug
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 group | Role | What they receive |
|---|---|---|
| A.individual therapy | Experimental | 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. Receives: Drug: carboplatin, gemcitabine , pametrexed |
| B. non-individualized therapy | Experimental | 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. Receives: Drug: carboplatin, gemcitabine , pametrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Followed up these patients for disease-free survival for 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startJun 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heyuwen, Guangzhou Medical University
- Investigators
- Jianxing He, Proressor, Study chair, The first affiliated hospital of Guangzhou MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781988
- Sponsor's protocol ID
- GZMC12521
- Other IDs
- PT12521
- Acronym
- PTINCLC
- Status last verified
- Dec 2014
- First submitted
- 24 Jan 2013
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25732635
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Personalized Therapy for Non-small Cell Lung Cancer Based on ERCC1/RRM1/TS Expression
- ClinicalTrials.gov ID
- NCT01781988
- Acronym / sponsor ID
- PTINCLC / GZMC12521
- Conditions
- Lung Cancer, Carboplatin Adverse Reaction
- Keywords
- lung cancer, gemcitabine, carboplatin, pemetrexed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University
- Study start
- Jun 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A.individual therapy | Experimental | Drug: carboplatin, gemcitabine , pametrexedCarboplatin 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. |
| B. non-individualized therapy | Experimental | Drug: carboplatin, gemcitabine , pametrexedCarboplatin 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatin, gemcitabine , pametrexedA.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. | Drug | A.individual therapy, B. non-individualized therapy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
- Derived from this study: PubMed 25732635He 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianxing He, Proressor study chair
The first affiliated hospital of Guangzhou MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin, gemcitabine , pametrexed in people with Lung Cancer and Carboplatin Adverse Reaction, run by Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The disease-free survival (time frame: Followed up these patients for disease-free survival for 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01781988, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2014.