Chemotherapy, AdjuvantPhase 2NCT03351842
Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%
A Phase 2 study testing cis Platinum/Carboplatin, Pemetrexed Disodium and Undergo surgery in people with Chemotherapy, Adjuvant and Lung Adenocarcinoma, Stage I, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
Randomized phase II trial aims to compare surgery with or without adjuvant chemotherapy in treating patients who are pathologically diagnosed as stage I lung adenocarcinoma with micropapillary component no less than 20%. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Chemotherapy, Adjuvant, Lung Adenocarcinoma, Stage I, Treatment
- What is being tested?
- cis Platinum/Carboplatin, Pemetrexed Disodium and Undergo surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 1 Sep 2024
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completely resected Stage I NSCLC as defined by the International Staging System
- Pathologically diagnosed Stage I micropapillary predominant lung adenocarcinoma
- Patients must be randomized within 4 weeks from the date of surgery
- No prior chemotherapy or radiation for non-small cell lung cancer
- Performance status of 0 or 1
- Women must be non-pregnant and non-lactating; patients of childbearing potential must agree to use an effective form of contraception while on study
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- Patients must have no history of previous or concomitant malignancy, other than curatively treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin, or surgically treated in situ carcinoma of the breast, or other cancer for which the patient has been disease free for five years
- Granulocytes >= 1,800/ul
- Platelets >= 100,000/ul
- Bilirubin < 1.5 mg/dl
- SGOT(serum glutamic-oxaloacetic transaminase) (AST) < 2.0 x ULN(upper limit of normal value)
Who cannot join
- Do not meet the inclusion criteria
- There is evidence of distant metastases
- Suffered from other malignancies in five years
- Within the past January subjects received other drug trials
- Having serious allergies or idiosyncratic persons, such as you can not use folic acid, dexamethasone, vitamin B12 patients
- Severe lung or heart disease, a history
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- Refuses or is unable to sign informed consent to participate in trials
- The abuse of drugs or alcohol addicts.
- Patients with difficult to control bacterial, viral, fungal infections
- Having a personality or mental disorders, without civil capacity or restricted civil capacity.
- Being pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Thoracic Surgery Department of Shanghai Pulmonary Hospital
Shanghai, 200000
Yingran Shen, 86-18117166317, elaineshen91@gmail.com
About this study
Official title: A PHASE II STUDY Of ADJUVANT CHEMOTHERAPY After SURGERY For STAGE I Lung ADENOCARCINOMA PATIENTS With MICROPAPILLARY COMPONENT More Than Or EQUAL To 20%
Randomized phase II trial aims to compare surgery with or without adjuvant chemotherapy in treating patients who are pathologically diagnosed as stage I lung adenocarcinoma with micropapillary component no less than 20%.
Read the detailed description
The presence of micropapillary component in adenocarcinoma is a predictor of poor prognosis, and has been reported to be to be chemosensitive to platinum-based chemotherapy. Seeking a more appropriate treatment for these patients, we perform this randomized phase II clinical trial. About 460 stage I lung adenocarcinoma patients with micropapillary component ≥ 20% will be included and divided into two group. Patients in the control group will only undergo complete R0 resection of the lesion, no further therapy will be used. While patients in the experimental group are going to receive platinum-based chemotherapy (comprising cisplatin and pemetrexed disodium)about 1 month after therapeutic surgery. Treatment continues every 3 weeks for 4 courses. Clinic and telephone follow up will be conducted for survival data monitoring.
DFS(disease free survival rate) and OS(overall survival rate) curves will be calculated using the Kaplan-Meier, life-table method. Comparison of the survival curve for the two groups will be performed using the log-rank test.
- Conditions
- Chemotherapy, Adjuvant, Lung Adenocarcinoma, Stage I, Treatment, Histological Type of Neoplasm
- Being tested
- cis Platinum/Carboplatin, Pemetrexed Disodium, Undergo surgery
- Keywords
- Adjuvant chemotherapy, Micropapillary Component, Early stage lung cancer
- Medical subject headings
- Adenocarcinoma of Lung, Neoplasms by Histologic Type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cis Platinum/Carboplatin, Pemetrexed DisodiumDrug
Also called Pemetrexed Disodium for Injection, ALIMTA, Cisplatin, Paraplatin
Intravenous inject Pemetrexed Disodium for Injection over 10 minutes, waiting for at least 30 minutes, then followed by cis Platinum/ Carboplatin over 2 hours
Undergo surgeryProcedure or surgery
Therapeutic conventional surgery, R0 resection
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Undergo surgery, followed by observation. Patients receive no further therapy Receives: Procedure: Undergo surgery |
| Arm II | Experimental | Undergo surgery, followed by chemotherapy (cis Platinum/Carboplatin, Pemetrexed Disodium). Patients receive chemotherapy comprising cisplatin 75mg/m2 or Carboplatin AUC=5mg/ml/min, and pemetrexed 500mg/m2 in day 1. Treatment continues every 3 weeks for 4 courses. Receives: Drug: cis Platinum/Carboplatin, Pemetrexed Disodium; Procedure: Undergo surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free-Survival-Rate
the percentage of people in the trial who are alive and cancer free after a specified number of years
Measured: up to 60 months
Secondary outcomes (3)
Overall-Survival-Rate
the percentage of people in the trial who alive, with or without signs of cancer
Measured: up to 60 months
Disease-Free-Survival-Time
From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first
Measured: up to 60 months
Overall-Survival-Time
Time from randomization until death from any cause
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2024 (estimated)
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 Chemotherapy, AdjuvantStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gening Jiang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351842
- Sponsor's protocol ID
- K17-151
- Status last verified
- Dec 2017
- First submitted
- 20 Nov 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zhou Y, Bian D, Yang F, Xu X, Shen Y, Chen L, Dai J, Xu X, Zhu Y, Zhao D, Zhang P, Liu X, Jin K, Jiang G. Adjuvant chemotherapy for resected stage-ia lung adenocarcinoma with micropapillary histologic pattern. Interdiscip Cardiovasc Thorac Surg. 2026 Jun 9:ivag165. doi: 10.1093/icvts/ivag165. Online ahead of print.
PubMed 42266006
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE II STUDY Of ADJUVANT CHEMOTHERAPY After SURGERY For STAGE I Lung ADENOCARCINOMA PATIENTS With MICROPAPILLARY COMPONENT More Than Or EQUAL To 20%
- ClinicalTrials.gov ID
- NCT03351842
- Acronym / sponsor ID
- K17-151
- Conditions
- Chemotherapy, Adjuvant, Lung Adenocarcinoma, Stage I, Treatment, Histological Type of Neoplasm
- Keywords
- Adjuvant chemotherapy, Micropapillary Component, Early stage lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 24 Nov 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.
Randomized phase II trial aims to compare surgery with or without adjuvant chemotherapy in treating patients who are pathologically diagnosed as stage I lung adenocarcinoma with micropapillary component no less than 20%.
Detailed description
The presence of micropapillary component in adenocarcinoma is a predictor of poor prognosis, and has been reported to be to be chemosensitive to platinum-based chemotherapy. Seeking a more appropriate treatment for these patients, we perform this randomized phase II clinical trial. About 460 stage I lung adenocarcinoma patients with micropapillary component ≥ 20% will be included and divided into two group. Patients in the control group will only undergo complete R0 resection of the lesion, no further therapy will be used. While patients in the experimental group are going to receive platinum-based chemotherapy (comprising cisplatin and pemetrexed disodium)about 1 month after therapeutic surgery. Treatment continues every 3 weeks for 4 courses. Clinic and telephone follow up will be conducted for survival data monitoring.
DFS(disease free survival rate) and OS(overall survival rate) curves will be calculated using the Kaplan-Meier, life-table method. Comparison of the survival curve for the two groups will be performed using the log-rank test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Procedure: Undergo surgeryUndergo surgery, followed by observation. Patients receive no further therapy |
| Arm II | Experimental | Drug: cis Platinum/Carboplatin, Pemetrexed Disodium, Procedure: Undergo surgeryUndergo surgery, followed by chemotherapy (cis Platinum/Carboplatin, Pemetrexed Disodium). Patients receive chemotherapy comprising cisplatin 75mg/m2 or Carboplatin AUC=5mg/ml/min, and pemetrexed 500mg/m2 in day 1. Treatment continues every 3 weeks for 4 courses. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Completely resected Stage I NSCLC as defined by the International Staging System
- Pathologically diagnosed Stage I micropapillary predominant lung adenocarcinoma
- Patients must be randomized within 4 weeks from the date of surgery
- No prior chemotherapy or radiation for non-small cell lung cancer
- Performance status of 0 or 1
Key exclusion criteria (11 listed)
- Do not meet the inclusion criteria
- There is evidence of distant metastases
- Suffered from other malignancies in five years
- Within the past January subjects received other drug trials
- Having serious allergies or idiosyncratic persons, such as you can not use folic acid, dexamethasone, vitamin B12 patients
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 |
|---|---|---|
| cis Platinum/Carboplatin, Pemetrexed DisodiumAlso: Pemetrexed Disodium for Injection, ALIMTA, Cisplatin, ParaplatinIntravenous inject Pemetrexed Disodium for Injection over 10 minutes, waiting for at least 30 minutes, then followed by cis Platinum/ Carboplatin over 2 hours | Drug | Arm II |
| Undergo surgeryTherapeutic conventional surgery, R0 resection | Procedure or surgery | Arm I, Arm II |
Primary outcome
Disease-Free-Survival-Rate
Time frame: up to 60 months
the percentage of people in the trial who are alive and cancer free after a specified number of years
3 secondary outcomes
Overall-Survival-Rate
Time frame: up to 60 months
Disease-Free-Survival-Time
Time frame: up to 60 months
Overall-Survival-Time
Time frame: up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Derived from this study: PubMed 42266006Zhou Y, Bian D, Yang F, Xu X, Shen Y, Chen L, Dai J, Xu X, Zhu Y, Zhao D, Zhang P, Liu X, Jin K, Jiang G. Adjuvant chemotherapy for resected stage-ia lung adenocarcinoma with micropapillary histologic pattern. Interdiscip Cardiovasc Thorac Surg. 2026 Jun 9:ivag165. doi: 10.1093/icvts/ivag165. Online ahead of print.
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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.
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 cis Platinum/Carboplatin, Pemetrexed Disodium and Undergo surgery in people with Chemotherapy, Adjuvant and Lung Adenocarcinoma, Stage I, run by Shanghai Pulmonary Hospital, Shanghai, China 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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 19 Dec 2017. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yingran Shen, PhD (86-18117166317, elaineshen91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free-Survival-Rate (time frame: up to 60 months). 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 NCT03351842, 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 19 Dec 2017.