Non-small Cell Lung Cancer Stage IIIAPhase 2ZTOG-1202NCT01926483
Phase II Trial of Regimen for Stage III (N2) NSCLC Using Induction Treatment Followed by Resection
A Phase 2 study testing Neoadjuvant Chemoradiotherapy in people with Non-small Cell Lung Cancer Stage IIIA, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The investigators hypothesized that the Neoadjuvant Chemoradiotherapy was a beneficial treatment for Patients with Stage IIIA-N2 Non-Small Cell Lung Cancer, so we try to evaluate the security of treatment, the QoL of patients and the influence to the PFS and OS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage IIIA
- What is being tested?
- Neoadjuvant Chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Jun 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18≤Age≤65;
- ECOG performance status of 0 or 1;
- Pathological diagnosis with Stage IIIA-N2 NSCLC which is clinically resectable and the N2 is diagnosed by either mediastinoscopy,EBUS,PET/CT;
- WBC≥4.0×109/l, ANC≥1.5×109/l, PLT≥100.0×109/l, Hb≥90g/l;hepatorenal function is normal;
- Without a history of other malignancies before enrollment, except for non-melanoma skin cancer, in situ cervical cancer;
- The patient can understand the research and sign the informed consent.
Who cannot join
- Female in pregnancy or lactating;Female of childbearing age without contraception;
- With acute infection or other serious underlying disease;
- With a significant history of neurological of psychiatric disease，including the dementia which may affect the ability to understand and sign the informed consent;
- Have received other treatment within the last 30 days before enrollment;
- With uncontrollable diabetes(blood glucose is unstable after treatment or FBG≥8mol/L).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xu Yaping, +0086-571-88122082, xuyaping1207@gmail.com
About this study
Official title: A Prospective, Phase II Trial of a Trimodality Regimen for Stage III (N2) Non-small-cell Lung Cancer Using Concurrent Chemoradiotherapy as Induction Treatment Followed by Subsequent Resection
The investigators hypothesized that the Neoadjuvant Chemoradiotherapy was a beneficial treatment for Patients with Stage IIIA-N2 Non-Small Cell Lung Cancer, so we try to evaluate the security of treatment, the QoL of patients and the influence to the PFS and OS.
Read the detailed description
Scheme:
Patients will receive different chemotherapy regimens depending on the pathological type.
Squamous cell carcinoma:Docetaxel/Cisplatin and concurrent radiation (46Gy/23f) followed by surgery, consolidate Docetaxel/Cisplatin 2 cycles.
Non-squamous cell carcinoma:Pemetrexed/Cisplatin and concurrent radiation (46Gy/23f) followed by surgery, consolidate Pemetrexed/Cisplatin 2 cycles.
- Conditions
- Non-small Cell Lung Cancer Stage IIIA
- Being tested
- Neoadjuvant Chemoradiotherapy
- Keywords
- Stage IIIA-N2 NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant ChemoradiotherapyOther
Surgery followed by cisplatin-based regimen and concurrent radiation (46Gy/23f), consolidate the original regimen 2 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Treatment | Experimental | Neoadjuvant Chemoradiotherapy Receives: Other: Neoadjuvant Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: up to 3 years
Secondary outcomes (3)
Adverse events
observe and record the toxicity profile(including but not limit to mucositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edition) during the neoadjuvant chemoradiation and follow-up.
Measured: participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years
QOL
Measured: up to 3 years
OS
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IIIAStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weimin Mao, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926483
- Sponsor's protocol ID
- ZTOG-1202
- Acronym
- ZTOG-1202
- Status last verified
- Jul 2012
- First submitted
- 4 Jun 2013
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Phase II Trial of a Trimodality Regimen for Stage III (N2) Non-small-cell Lung Cancer Using Concurrent Chemoradiotherapy as Induction Treatment Followed by Subsequent Resection
- ClinicalTrials.gov ID
- NCT01926483
- Acronym / sponsor ID
- ZTOG-1202 / ZTOG-1202
- Conditions
- Non-small Cell Lung Cancer Stage IIIA
- Keywords
- Stage IIIA-N2 NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 21 Aug 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.
The investigators hypothesized that the Neoadjuvant Chemoradiotherapy was a beneficial treatment for Patients with Stage IIIA-N2 Non-Small Cell Lung Cancer, so we try to evaluate the security of treatment, the QoL of patients and the influence to the PFS and OS.
Detailed description
Scheme:
Patients will receive different chemotherapy regimens depending on the pathological type.
Squamous cell carcinoma:Docetaxel/Cisplatin and concurrent radiation (46Gy/23f) followed by surgery, consolidate Docetaxel/Cisplatin 2 cycles.
Non-squamous cell carcinoma:Pemetrexed/Cisplatin and concurrent radiation (46Gy/23f) followed by surgery, consolidate Pemetrexed/Cisplatin 2 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Treatment | Experimental | Other: Neoadjuvant ChemoradiotherapyNeoadjuvant Chemoradiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18≤Age≤65;
- ECOG performance status of 0 or 1;
- Pathological diagnosis with Stage IIIA-N2 NSCLC which is clinically resectable and the N2 is diagnosed by either mediastinoscopy,EBUS,PET/CT;
- WBC≥4.0×109/l, ANC≥1.5×109/l, PLT≥100.0×109/l, Hb≥90g/l;hepatorenal function is normal;
- Without a history of other malignancies before enrollment, except for non-melanoma skin cancer, in situ cervical cancer;
Key exclusion criteria (5 listed)
- Female in pregnancy or lactating;Female of childbearing age without contraception;
- With acute infection or other serious underlying disease;
- With a significant history of neurological of psychiatric disease，including the dementia which may affect the ability to understand and sign the informed consent;
- Have received other treatment within the last 30 days before enrollment;
- With uncontrollable diabetes(blood glucose is unstable after treatment or FBG≥8mol/L).
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 |
|---|---|---|
| Neoadjuvant ChemoradiotherapySurgery followed by cisplatin-based regimen and concurrent radiation (46Gy/23f), consolidate the original regimen 2 cycles. | Other | Neoadjuvant Treatment |
Primary outcome
PFS
Time frame: up to 3 years
3 secondary outcomes
Adverse events
Time frame: participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years
QOL
Time frame: up to 3 years
OS
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
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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.
Weimin Mao, MD principal investigator
Zhejiang Cancer Hospital
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 Neoadjuvant Chemoradiotherapy in people with Non-small Cell Lung Cancer Stage IIIA, run by Zhejiang Cancer 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 6 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: status not confirmed, as of the sponsor's last update on 21 Aug 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiming Mao, MD (+86-571-88122032, maowmzj1218@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 3 years). 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 21 Aug 2013.