Lung NeoplasmsPhase 2/3ECTOP-1004NCT03380468
Adjuvant Chemotherapy for High Risk Stage I Lung Adenocarcinoma
A Phase 2/3 study testing cisplatin plus pemetrexed in people with Lung Neoplasms, run by Fudan University at 1 site in China.
Trial summary
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1004. Solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation are high risk factors of post-operative recurrence for early-stage lung adenocarcinoma patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- cisplatin plus pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2025
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage pI lung adenocarcinoma confirmed through formalin-fixed paraffin-embedded tumor tissue, complete resection with mediastinal lymph node dissection
- Meet one of following conditions: a, Solid predominant adenocarcinomas; b, micropapillary predominant adenocarcinoma; c, low differentiation, unable to identify histological subtypes; d, pleural involvement; e, vascular involvement with solid subtype component or micropapillary component.
- Aged 18-70 years old.
- Eastern Cooperative Oncology Group score standard (ECOG) status 0-1.
- Medical condition permits adjuvant chemotherapy.
- Patients accept the clinical trial protocol and Informed Consent Form (ICF) signed.
Who cannot join
- Concurrent other malignancies
- Prior chemotherapy and/or radiation therapy for lung cancer
- Central type lung cancer
- Concurrent other unresected suspicious nodules or masses in lung
- Medical condition that will not permit treatment or follow up according to the protocol, or ECOG status >1.
- Pregnant or nursing women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Cancer Center
Shanghai, Shanghai Municipality, 200032
Chen Haiquan, MD, +86-21 64175590 ext. 1707, hqchen1@yahoo.com
About this study
Official title: Adjuvant Chemotherapy Versus Observation in Fully Resected Stage I Lung Adenocarcinoma With High Risk of Post-operative Recurrence
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1004. Solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation are high risk factors of post-operative recurrence for early-stage lung adenocarcinoma patients. The purpose of this clinical trial is to determine whether the widely used adjuvant chemotherapy strategy cisplatin/ pemetrexed is more effective than no further treatment for Stage pI lung adenocarcinoma patients with high post-operative recurrence risk - in terms of no dose related toxicities, premature treatment withdrawal or death.
Read the detailed description
Background:
Management of lung cancer varies according to the clinical and pathological stage. For stage I lung adenocarcinoma, radical surgery is the preferred initial treatment and adjuvant chemotherapy is usually not recommended due to a fine prognosis and relatively low post-operative recurrence rate. Still, a number of stage pI patients will suffer a relapse after surgery, among which are highly associated with solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation. Recently, some retrospective researches have shown a significant survival benefit of adjuvant chemotherapy for such stage pI high-recurrent-risk patients, but there lacks evidence from prospective randomized clinical trails.
Objective:
- Major: to compare disease free survival and over all survival of fully resected stage pI high-recurrent-risk patients from both arms (adjuvant chemotherapy vs. observation)
- To assess the safety and efficacy of chemotherapy regimen cisplatin plus pemetrexed to fully resected stage pI high-recurrent-risk patients.
- To collect clinical pathological characteristics and prognosis information of stage pI patients with solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation.
- To determine the association among age, gender, smoking history, pathological subtypes, histological differentiation, pleural involvement, vascular involvement and driving mutations.
Randomization:
Each of the patients enrolled will be recorded in the computer system. Blank randomization will be done using a digital randomization software, at least 1 week before the first time of chemotherapy or observation.
Prechemotherapy assessment: For all the patients enrolled, the postoperative physical or laboratory examination should be equally qualified no matter which group they will be in. For Group Adjuvant Chemotherapy patients, they will receive laboratory examinations before chemotherapy to test blood cells and liver function in consideration of safety as routine.
Follow up:
Patients will be followed up per 4 months for the first three years and each six months for the forth to fifth years during the research. Lung multi-detector row computed tomography (MDCT) and abdominal ultrasonography tests will be done twice a year; bone SPECT scan and enhanced brain MRI scan will be conducted per year routinely. Patients will be suggested to continue the annual follow-up after the research.
Main research variables:
Primary end point: Disease free survival in the two arms
Secondary endpoints:
- Overall survival
- Recurrence pattern: Locoregional recurrence, metastatic recurrence, or both
- Quality of life: assessed with Eastern Cooperative Oncology Group- quality of life questionnaire(EORTC QLQ-C30/- LC13) scale.
This study is recognized in our institute as "Eastern Cooperative Thoracic Oncology Projects (ECTOP-1004)"
- Conditions
- Lung Neoplasms
- Being tested
- cisplatin plus pemetrexed
- Keywords
- Lung adenocarcinoma, adjuvant chemotherapy
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatin plus pemetrexedDrug
cisplatin 75mg/m2 iv; pemetrexed 500mg/m2 iv
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin plus pemetrexed | Experimental | Drug: cisplatin 75mg/m2 iv Drug: pemetrexed 500mg/m2 iv Receives: Drug: cisplatin plus pemetrexed |
| Observation | No intervention | Observation and follow up only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival (RFS)
from date of randomization until the date of showing signs of relapse, including evidence of medical image or pathology.
Measured: up to 5 years
Secondary outcomes (1)
Overall survival (OS)
from date of randomization until the date of death from any cause, withdrawal of consent, or the end of the study.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start1 Jan 2018
- Primary completion1 Jan 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
- Investigators
- Haiquan Chen, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380468
- Sponsor's protocol ID
- ECTOP-1004
- Acronym
- ECTOP-1004
- Status last verified
- Jul 2023
- First submitted
- 1 Nov 2017
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
PubMed 26808342Kelsey CR, Marks LB, Hollis D, Hubbs JL, Ready NE, D'Amico TA, Boyd JA. Local recurrence after surgery for early stage lung cancer: an 11-year experience with 975 patients. Cancer. 2009 Nov 15;115(22):5218-27. doi: 10.1002/cncr.24625.
PubMed 19672942Zhang Y, Li J, Wang R, Li Y, Pan Y, Cai D, Hu H, Li H, Ye T, Luo X, Zhang Y, Li B, Shen L, Sun Y, Chen H. The prognostic and predictive value of solid subtype in invasive lung adenocarcinoma. Sci Rep. 2014 Nov 24;4:7163. doi: 10.1038/srep07163.
PubMed 25418354Zhang Y, Wang R, Cai D, Li Y, Pan Y, Hu H, Wang L, Li H, Ye T, Luo X, Zhang Y, Li B, Shen L, Sun Y, Chen H. A comprehensive investigation of molecular features and prognosis of lung adenocarcinoma with micropapillary component. J Thorac Oncol. 2014 Dec;9(12):1772-8. doi: 10.1097/JTO.0000000000000341.
PubMed 25226429Yoshizawa A, Motoi N, Riely GJ, Sima CS, Gerald WL, Kris MG, Park BJ, Rusch VW, Travis WD. Impact of proposed IASLC/ATS/ERS classification of lung adenocarcinoma: prognostic subgroups and implications for further revision of staging based on analysis of 514 stage I cases. Mod Pathol. 2011 May;24(5):653-64. doi: 10.1038/modpathol.2010.232. Epub 2011 Jan 21.
PubMed 21252858Shimada Y, Saji H, Yoshida K, Kakihana M, Honda H, Nomura M, Usuda J, Kajiwara N, Ohira T, Ikeda N. Pathological vascular invasion and tumor differentiation predict cancer recurrence in stage IA non-small-cell lung cancer after complete surgical resection. J Thorac Oncol. 2012 Aug;7(8):1263-70. doi: 10.1097/JTO.0b013e31825cca6e.
PubMed 22673056Al-Alao BS, Gately K, Nicholson S, McGovern E, Young VK, O'Byrne KJ. Prognostic impact of vascular and lymphovascular invasion in early lung cancer. Asian Cardiovasc Thorac Ann. 2014 Jan;22(1):55-64. doi: 10.1177/0218492313478431. Epub 2013 Sep 4.
PubMed 24585645Chen YY, Huang TW, Tsai WC, Lin LF, Cheng JB, Lee SC, Chang H. Lymphovascular space invasion and tumor differentiation are predictors for postoperative recurrence in patients with pathological stage I nonsmall cell lung cancer. J Chin Med Assoc. 2014 Aug;77(8):416-21. doi: 10.1016/j.jcma.2014.05.008. Epub 2014 Jul 12.
PubMed 25028298Park C, Lee IJ, Jang SH, Lee JW. Factors affecting tumor recurrence after curative surgery for NSCLC: impacts of lymphovascular invasion on early tumor recurrence. J Thorac Dis. 2014 Oct;6(10):1420-8. doi: 10.3978/j.issn.2072-1439.2014.09.31.
PubMed 25364519Yano M, Sasaki H, Moriyama S, Kawano O, Hikosaka Y, Fujii Y. Prognostic factors of pathologic stage IB non-small cell lung cancer. Ann Thorac Cardiovasc Surg. 2011;17(1):58-62. doi: 10.5761/atcs.cr.09.01481.
PubMed 21587131Huang H, Wang T, Hu B, Pan C. Visceral pleural invasion remains a size-independent prognostic factor in stage I non-small cell lung cancer. Ann Thorac Surg. 2015 Apr;99(4):1130-9. doi: 10.1016/j.athoracsur.2014.11.052. Epub 2015 Feb 20.
PubMed 25704861Jiang L, Liang W, Shen J, Chen X, Shi X, He J, Yang C, He J. The impact of visceral pleural invasion in node-negative non-small cell lung cancer: a systematic review and meta-analysis. Chest. 2015 Oct;148(4):903-911. doi: 10.1378/chest.14-2765.
PubMed 25675151Butts CA, Ding K, Seymour L, Twumasi-Ankrah P, Graham B, Gandara D, Johnson DH, Kesler KA, Green M, Vincent M, Cormier Y, Goss G, Findlay B, Johnston M, Tsao MS, Shepherd FA. Randomized phase III trial of vinorelbine plus cisplatin compared with observation in completely resected stage IB and II non-small-cell lung cancer: updated survival analysis of JBR-10. J Clin Oncol. 2010 Jan 1;28(1):29-34. doi: 10.1200/JCO.2009.24.0333. Epub 2009 Nov 23.
PubMed 19933915Strauss GM, Herndon JE 2nd, Maddaus MA, Johnstone DW, Johnson EA, Harpole DH, Gillenwater HH, Watson DM, Sugarbaker DJ, Schilsky RL, Vokes EE, Green MR. Adjuvant paclitaxel plus carboplatin compared with observation in stage IB non-small-cell lung cancer: CALGB 9633 with the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and North Central Cancer Treatment Group Study Groups. J Clin Oncol. 2008 Nov 1;26(31):5043-51. doi: 10.1200/JCO.2008.16.4855. Epub 2008 Sep 22.
PubMed 18809614Luo J, Huang Q, Wang R, Han B, Zhang J, Zhao H, Fang W, Luo Q, Yang J, Yang Y, Zhu L, Chen T, Cheng X, Wang Y, Zheng J, Wu H, Xia W, Chen H. Prognostic and predictive value of the novel classification of lung adenocarcinoma in patients with stage IB. J Cancer Res Clin Oncol. 2016 Sep;142(9):2031-40. doi: 10.1007/s00432-016-2192-6. Epub 2016 Jul 5.
PubMed 27379889
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chemotherapy Versus Observation in Fully Resected Stage I Lung Adenocarcinoma With High Risk of Post-operative Recurrence
- ClinicalTrials.gov ID
- NCT03380468
- Acronym / sponsor ID
- ECTOP-1004 / ECTOP-1004
- Conditions
- Lung Neoplasms
- Keywords
- Lung adenocarcinoma, adjuvant chemotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Dec 2017 (actual)
- 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.
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1004. Solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation are high risk factors of post-operative recurrence for early-stage lung adenocarcinoma patients. The purpose of this clinical trial is to determine whether the widely used adjuvant chemotherapy strategy cisplatin/ pemetrexed is more effective than no further treatment for Stage pI lung adenocarcinoma patients with high post-operative recurrence risk - in terms of no dose related toxicities, premature treatment withdrawal or death.
Detailed description
Background:
Management of lung cancer varies according to the clinical and pathological stage. For stage I lung adenocarcinoma, radical surgery is the preferred initial treatment and adjuvant chemotherapy is usually not recommended due to a fine prognosis and relatively low post-operative recurrence rate. Still, a number of stage pI patients will suffer a relapse after surgery, among which are highly associated with solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation. Recently, some retrospective researches have shown a significant survival benefit of adjuvant chemotherapy for such stage pI high-recurrent-risk patients, but there lacks evidence from prospective randomized clinical trails.
Objective:
- Major: to compare disease free survival and over all survival of fully resected stage pI high-recurrent-risk patients from both arms (adjuvant chemotherapy vs. observation)
- To assess the safety and efficacy of chemotherapy regimen cisplatin plus pemetrexed to fully resected stage pI high-recurrent-risk patients.
- To collect clinical pathological characteristics and prognosis information of stage pI patients with solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low differentiation.
- To determine the association among age, gender, smoking history, pathological subtypes, histological differentiation, pleural involvement, vascular involvement and driving mutations.
Randomization:
Each of the patients enrolled will be recorded in the computer system. Blank randomization will be done using a digital randomization software, at least 1 week before the first time of chemotherapy or observation.
Prechemotherapy assessment: For all the patients enrolled, the postoperative physical or laboratory examination should be equally qualified no matter which group they will be in. For Group Adjuvant Chemotherapy patients, they will receive laboratory examinations before chemotherapy to test blood cells and liver function in consideration of safety as routine.
Follow up:
Patients will be followed up per 4 months for the first three years and each six months for the forth to fifth years during the research. Lung multi-detector row computed tomography (MDCT) and abdominal ultrasonography tests will be done twice a year; bone SPECT scan and enhanced brain MRI scan will be conducted per year routinely. Patients will be suggested to continue the annual follow-up after the research.
Main research variables:
Primary end point: Disease free survival in the two arms
Secondary endpoints:
- Overall survival
- Recurrence pattern: Locoregional recurrence, metastatic recurrence, or both
- Quality of life: assessed with Eastern Cooperative Oncology Group- quality of life questionnaire(EORTC QLQ-C30/- LC13) scale.
This study is recognized in our institute as "Eastern Cooperative Thoracic Oncology Projects (ECTOP-1004)"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cisplatin plus pemetrexed | Experimental | Drug: cisplatin plus pemetrexedDrug: cisplatin 75mg/m2 iv Drug: pemetrexed 500mg/m2 iv |
| Observation | No intervention | –Observation and follow up only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stage pI lung adenocarcinoma confirmed through formalin-fixed paraffin-embedded tumor tissue, complete resection with mediastinal lymph node dissection
- Meet one of following conditions: a, Solid predominant adenocarcinomas; b, micropapillary predominant adenocarcinoma; c, low differentiation, unable to identify histological subtypes; d, pleural involvement; e, vascular involvement with solid subtype component or micropapillary component.
- Aged 18-70 years old.
- Eastern Cooperative Oncology Group score standard (ECOG) status 0-1.
- Medical condition permits adjuvant chemotherapy.
Key exclusion criteria (6 listed)
- Concurrent other malignancies
- Prior chemotherapy and/or radiation therapy for lung cancer
- Central type lung cancer
- Concurrent other unresected suspicious nodules or masses in lung
- Medical condition that will not permit treatment or follow up according to the protocol, or ECOG status >1.
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 |
|---|---|---|
| cisplatin plus pemetrexedcisplatin 75mg/m2 iv; pemetrexed 500mg/m2 iv | Drug | Cisplatin plus pemetrexed |
Primary outcome
Recurrence free survival (RFS)
Time frame: up to 5 years
from date of randomization until the date of showing signs of relapse, including evidence of medical image or pathology.
1 secondary outcome
Overall survival (OS)
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 26808342Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
- Background: PubMed 19672942Kelsey CR, Marks LB, Hollis D, Hubbs JL, Ready NE, D'Amico TA, Boyd JA. Local recurrence after surgery for early stage lung cancer: an 11-year experience with 975 patients. Cancer. 2009 Nov 15;115(22):5218-27. doi: 10.1002/cncr.24625.
- Background: PubMed 25418354Zhang Y, Li J, Wang R, Li Y, Pan Y, Cai D, Hu H, Li H, Ye T, Luo X, Zhang Y, Li B, Shen L, Sun Y, Chen H. The prognostic and predictive value of solid subtype in invasive lung adenocarcinoma. Sci Rep. 2014 Nov 24;4:7163. doi: 10.1038/srep07163.
- Background: PubMed 25226429Zhang Y, Wang R, Cai D, Li Y, Pan Y, Hu H, Wang L, Li H, Ye T, Luo X, Zhang Y, Li B, Shen L, Sun Y, Chen H. A comprehensive investigation of molecular features and prognosis of lung adenocarcinoma with micropapillary component. J Thorac Oncol. 2014 Dec;9(12):1772-8. doi: 10.1097/JTO.0000000000000341.
- Background: PubMed 21252858Yoshizawa A, Motoi N, Riely GJ, Sima CS, Gerald WL, Kris MG, Park BJ, Rusch VW, Travis WD. Impact of proposed IASLC/ATS/ERS classification of lung adenocarcinoma: prognostic subgroups and implications for further revision of staging based on analysis of 514 stage I cases. Mod Pathol. 2011 May;24(5):653-64. doi: 10.1038/modpathol.2010.232. Epub 2011 Jan 21.
- Background: PubMed 22673056Shimada Y, Saji H, Yoshida K, Kakihana M, Honda H, Nomura M, Usuda J, Kajiwara N, Ohira T, Ikeda N. Pathological vascular invasion and tumor differentiation predict cancer recurrence in stage IA non-small-cell lung cancer after complete surgical resection. J Thorac Oncol. 2012 Aug;7(8):1263-70. doi: 10.1097/JTO.0b013e31825cca6e.
- Background: PubMed 24585645Al-Alao BS, Gately K, Nicholson S, McGovern E, Young VK, O'Byrne KJ. Prognostic impact of vascular and lymphovascular invasion in early lung cancer. Asian Cardiovasc Thorac Ann. 2014 Jan;22(1):55-64. doi: 10.1177/0218492313478431. Epub 2013 Sep 4.
- Background: PubMed 25028298Chen YY, Huang TW, Tsai WC, Lin LF, Cheng JB, Lee SC, Chang H. Lymphovascular space invasion and tumor differentiation are predictors for postoperative recurrence in patients with pathological stage I nonsmall cell lung cancer. J Chin Med Assoc. 2014 Aug;77(8):416-21. doi: 10.1016/j.jcma.2014.05.008. Epub 2014 Jul 12.
- Background: PubMed 25364519Park C, Lee IJ, Jang SH, Lee JW. Factors affecting tumor recurrence after curative surgery for NSCLC: impacts of lymphovascular invasion on early tumor recurrence. J Thorac Dis. 2014 Oct;6(10):1420-8. doi: 10.3978/j.issn.2072-1439.2014.09.31.
- Background: PubMed 21587131Yano M, Sasaki H, Moriyama S, Kawano O, Hikosaka Y, Fujii Y. Prognostic factors of pathologic stage IB non-small cell lung cancer. Ann Thorac Cardiovasc Surg. 2011;17(1):58-62. doi: 10.5761/atcs.cr.09.01481.
- Background: PubMed 25704861Huang H, Wang T, Hu B, Pan C. Visceral pleural invasion remains a size-independent prognostic factor in stage I non-small cell lung cancer. Ann Thorac Surg. 2015 Apr;99(4):1130-9. doi: 10.1016/j.athoracsur.2014.11.052. Epub 2015 Feb 20.
- Background: PubMed 25675151Jiang L, Liang W, Shen J, Chen X, Shi X, He J, Yang C, He J. The impact of visceral pleural invasion in node-negative non-small cell lung cancer: a systematic review and meta-analysis. Chest. 2015 Oct;148(4):903-911. doi: 10.1378/chest.14-2765.
- Individual participant dataSharing planned: Undecided
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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.
Haiquan Chen, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing cisplatin plus pemetrexed in people with Lung Neoplasms, run by Fudan 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Jul 2023. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haiquan Chen, MD (+86-21 64175590 ext. 1707, hqchen1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival (RFS) (time frame: up to 5 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 NCT03380468, which also lists 21 linked publications.
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 20 Jul 2023.