Neoplasms, Therapy-AssociatedPhase 4NCT02283424
Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With EGFR Gene Mutation
A Phase 4 study testing Icotinib and chemotherapy (Carboplatin and Docetaxel) in people with Neoplasms, Therapy-Associated, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This is a randomized ,opened, prospective controlled trial of clinical effectiveness for Icotinib as the adjunctive treatment after surgery in stage I-IIIB lung adenocarcinoma patients with epidermal growth factor receptor gene mutation Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoplasms, Therapy-Associated
- What is being tested?
- Icotinib and chemotherapy (Carboplatin and Docetaxel)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Dec 2017
- Phase
- Phase 4
- 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
- 18-75 years old
- Lung adenocarcinoma patients with epidermal growth factor receptor gene mutation,stage I-IIIB after surgery
- The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2
Who cannot join
- Mismatch conditions above
- Have used other anti-cancer therapy drug before the trial and may influence the outcome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized ,Opened, Prospective Controlled Trial of Clinical Effectiveness for Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With Epidermal Growth Factor Receptor Gene Mutation
This is a randomized ,opened, prospective controlled trial of clinical effectiveness for Icotinib as the adjunctive treatment after surgery in stage I-IIIB lung adenocarcinoma patients with epidermal growth factor receptor gene mutation
Read the detailed description
In this trial the investigators will enlist 100 patients who accepted surgery and with epidermal growth factor receptor gene mutation,these patients will be divided into 2 groups (chemotherapy group and Icotinib group),compare the PFS,RFS,OS after 5 years follow up
- Conditions
- Neoplasms, Therapy-Associated
- Being tested
- Icotinib, chemotherapy (Carboplatin and Docetaxel)
- Medical subject headings
- Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcotinibDrug
Also called Conmana
compared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery
chemotherapy (Carboplatin and Docetaxel)Drug
Also called Carboplatin and Docetaxel
as control group,compared with Icotinib
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy | Active comparator | Carboplatin,350mg/m2,1/3weeks Docetaxel,75mg/m2,1/3weeks Receives: Drug: Icotinib; Drug: chemotherapy (Carboplatin and Docetaxel) |
| Icotinib | Experimental | Icotinib, 125mg,3/D,2years Receives: Drug: Icotinib; Drug: chemotherapy (Carboplatin and Docetaxel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free Survival
Measured: 6 months
Secondary outcomes (1)
Overall survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, Therapy-AssociatedStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Liu, Chinese PLA General Hospital
- Investigators
- Yang Liu, doctor, Study chair, PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283424
- Sponsor's protocol ID
- PLATS1401
- Status last verified
- Nov 2014
- First submitted
- 30 Oct 2014
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized ,Opened, Prospective Controlled Trial of Clinical Effectiveness for Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With Epidermal Growth Factor Receptor Gene Mutation
- ClinicalTrials.gov ID
- NCT02283424
- Acronym / sponsor ID
- PLATS1401
- Conditions
- Neoplasms, Therapy-Associated
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 5 Nov 2014 (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.
This is a randomized ,opened, prospective controlled trial of clinical effectiveness for Icotinib as the adjunctive treatment after surgery in stage I-IIIB lung adenocarcinoma patients with epidermal growth factor receptor gene mutation
Detailed description
In this trial the investigators will enlist 100 patients who accepted surgery and with epidermal growth factor receptor gene mutation,these patients will be divided into 2 groups (chemotherapy group and Icotinib group),compare the PFS,RFS,OS after 5 years follow up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | Active comparator | Drug: Icotinib, Drug: chemotherapy (Carboplatin and Docetaxel)Carboplatin,350mg/m2,1/3weeks Docetaxel,75mg/m2,1/3weeks |
| Icotinib | Experimental | Drug: Icotinib, Drug: chemotherapy (Carboplatin and Docetaxel)Icotinib, 125mg,3/D,2years |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 years old
- Lung adenocarcinoma patients with epidermal growth factor receptor gene mutation,stage I-IIIB after surgery
- The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2
Key exclusion criteria (2 listed)
- Mismatch conditions above
- Have used other anti-cancer therapy drug before the trial and may influence the outcome
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 |
|---|---|---|
| IcotinibAlso: Conmanacompared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery | Drug | Icotinib, chemotherapy |
| chemotherapy (Carboplatin and Docetaxel)Also: Carboplatin and Docetaxelas control group,compared with Icotinib | Drug | Icotinib, chemotherapy |
Primary outcome
Recurrence-free Survival
Time frame: 6 months
1 secondary outcome
Overall survival
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
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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.
Yang Liu, doctor study chair
PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Icotinib and chemotherapy (Carboplatin and Docetaxel) in people with Neoplasms, Therapy-Associated, run by Chinese PLA General Hospital 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 3 inclusion and 2 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 5 Nov 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Recurrence-free Survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2014.