Non-small Cell Lung CancerPhase 2RT0901NCT01091376
Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC)
A Phase 2 study testing Erlotinib and Thoracic radiotherapy in people with Non-small Cell Lung Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Erlotinib and Thoracic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Mar 2013
- 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 proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)
- Tumor EGFR mutation
- Presence of measurable disease by RECIST
- stage IIIA or IIIB, non-resectable
- ECOG performance status 0-2
- No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.
Who cannot join
- Carcinoid tumor, small cell carcinoma of lung
- Patients with any distant metastasis
- History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
- Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women
- Women and men of childbearing potential who have no willing of employing adequate contraception
- Tumor EGFR wild
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Shenglin Ma, MD, +8657188122568, mashenglin@medmail.com.cn
Yaping Xu, MD, +8657188122082, xuyaping1207@gmail.com
About this study
Official title: A Phase II Study of Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer
Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.
Read the detailed description
Patients with non-resectable Non-small Cell Lung Cancer will receive thoracic radiation therapy 60-70 Gy over 30-35 fractions and concurrent with Erlotinib 150mg/day. Followed by Erlotinib 150 mg/day consolidation treatment.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Erlotinib, Thoracic radiotherapy
- Keywords
- Non-small cell lung cancer, EGFR-TKI, Erlotinib, Radiotherapy
- 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.
ErlotinibDrug
Erlotinib 150mg/day
Thoracic radiotherapyRadiation
60-70Gy/30-35f
| Study group | Role | What they receive |
|---|---|---|
| Concomitant Erlotinib and radiotherapy | Experimental | Patients received Erlotinib and radiation therapy. Receives: Drug: Erlotinib; Radiation: Thoracic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.)
Measured: After the thoracic radiotherapy and concurrent Erlotinib treatment
The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)
Measured: Every one month
Secondary outcomes (3)
Progression free survival
Measured: The time from the start of treatment to diease progression
The overall survival
Measured: The time from the start of treatment to death
Quality of Life (QoL was evaluated according to the FACT-L.)
Measured: Every one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010 (estimated)
- Study completionMar 2013 (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 CancerStudies 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
- Investigators
- Shenglin Ma, MD, Principal investigator, Zhejiang Cancer HospitalLvhua Wang, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091376
- Sponsor's protocol ID
- ZhejiangCH02
- Acronym
- RT0901
- Status last verified
- Mar 2010
- First submitted
- 14 Jan 2010
- Last updated
- 17 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01091376
- Acronym / sponsor ID
- RT0901 / ZhejiangCH02
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, EGFR-TKI, Erlotinib, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 24 Mar 2010 (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.
Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.
Detailed description
Patients with non-resectable Non-small Cell Lung Cancer will receive thoracic radiation therapy 60-70 Gy over 30-35 fractions and concurrent with Erlotinib 150mg/day. Followed by Erlotinib 150 mg/day consolidation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concomitant Erlotinib and radiotherapy | Experimental | Drug: Erlotinib, Radiation: Thoracic radiotherapyPatients received Erlotinib and radiation therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)
- Tumor EGFR mutation
- Presence of measurable disease by RECIST
- stage IIIA or IIIB, non-resectable
- ECOG performance status 0-2
Key exclusion criteria (7 listed)
- Carcinoid tumor, small cell carcinoma of lung
- Patients with any distant metastasis
- History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
- Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women
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 |
|---|---|---|
| ErlotinibErlotinib 150mg/day | Drug | Concomitant Erlotinib and radiotherapy |
| Thoracic radiotherapy60-70Gy/30-35f | Radiation | Concomitant Erlotinib and radiotherapy |
Primary outcome
Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.)
Time frame: After the thoracic radiotherapy and concurrent Erlotinib treatment
The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)
Time frame: Every one month
3 secondary outcomes
Progression free survival
Time frame: The time from the start of treatment to diease progression
The overall survival
Time frame: The time from the start of treatment to death
Quality of Life (QoL was evaluated according to the FACT-L.)
Time frame: Every one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2010.
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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.
Shenglin Ma, MD principal investigator
Zhejiang Cancer Hospital
Lvhua Wang, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Erlotinib and Thoracic radiotherapy in people with Non-small Cell Lung Cancer, 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 7 inclusion and 7 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 17 May 2010. 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 Shenglin Ma, MD (+8657188122568, mashenglin@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.) (time frame: After the thoracic radiotherapy and concurrent Erlotinib treatment). The study lists 2 primary outcomes in all. 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 17 May 2010.