Non-small Cell Lung CancerPhase 3NCT01158170
Prophylactic Cranial Irradiation in Erlotinib/Gefitinib-responders With Non-small Cell Lung Cancer (NSCLC) (RT1001)
A Phase 3 study testing Prophylactic cranial irradiation and Erlotinib /Gefitinib in people with Non-small Cell Lung Cancer, run by Zhejiang Cancer Hospital at 2 sites in China.
Trial summary
RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer. 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?
- Prophylactic cranial irradiation and Erlotinib /Gefitinib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2010to Dec 2013
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were required to have histologically or cytologically documented
- NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
- No previous history of radiotherapy and surgery of brain
- good response( CR/PR) to Erlotinib or Gefitinib.
- Agree to radiotherapy
- age > 18 and <75 years,ECOG performance status 1 or less
- Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB>=80g /DL) functions
- Have provided informed consent
Who cannot join
- Seizure cannot be controled by the drugs
- Combined with other disease of the brain such as tumour or infarction
- Hypersensitivity to MR enhancer -
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
XuYa ping, MD, 0086-571-88122082, xuyaping1207@gmail.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Shenglin MA, MD, +8657188122568, mashenglin@medmail.com.cn
Yaping Xu, MD, +8657188122082, xuyaping1207@gmail.com
About this study
Official title: A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Effective on Erlotinib or Gefitinib(RT1001)
RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer
Read the detailed description
OBJECTIVES:
Primary
Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.
Secondary
Determine the progression-free survival in patients treated with this regimen. Determine the overall survival in patients treated with this regimen. Determine the safety and tolerability of this regimen in these patients. Determine the psycho-neurological effects of this regimen in these patients. Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients with good response( CR/PR) to EGFR-TKI(Erlotinib or Gefitinib) are randomized to receive EGFR-TKI plus PCI or EGFR-TKI alone,stratified according to prior chemotherapy regimens (first line vs second line), and disease response status.
Group 1: Patients undergo prophylactic brain radiotherapy. Group 2: Patients undergo observation. Patients complete quality of life questionnaires periodically.
After completion of study therapy, patients are followed up periodically.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Prophylactic cranial irradiation, Erlotinib /Gefitinib
- Keywords
- nonsmall cell lung cancer, brain metastasis, prophylactic cranial irradiation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic cranial irradiationRadiation
Also called PCI
25GY/10fraction
Erlotinib /GefitinibDrug
Also called EGFR-TKI
Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity
| Study group | Role | What they receive |
|---|---|---|
| prophylactic cranial irradiation | Experimental | Patients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions. Receives: Radiation: Prophylactic cranial irradiation; Drug: Erlotinib /Gefitinib |
| Conctrol | Active comparator | Patients received Erlotinib or gefitinib until disease progression,or intolerable toxicity Receives: Drug: Erlotinib /Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM)
Measured: 2.5years
Secondary outcomes (1)
overall survival
Measured: baseline to date of death from any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2013 (estimated)
- Study completionDec 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shenglin Ma, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158170
- Sponsor's protocol ID
- ZhejiangCH06
- Status last verified
- Jul 2010
- First submitted
- 23 Jun 2010
- Last updated
- 8 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Effective on Erlotinib or Gefitinib(RT1001)
- ClinicalTrials.gov ID
- NCT01158170
- Acronym / sponsor ID
- ZhejiangCH06
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- nonsmall cell lung cancer, brain metastasis, prophylactic cranial irradiation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- May 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 8 Jul 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.
RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer
Detailed description
OBJECTIVES:
Primary
Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.
Secondary
Determine the progression-free survival in patients treated with this regimen. Determine the overall survival in patients treated with this regimen. Determine the safety and tolerability of this regimen in these patients. Determine the psycho-neurological effects of this regimen in these patients. Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients with good response( CR/PR) to EGFR-TKI(Erlotinib or Gefitinib) are randomized to receive EGFR-TKI plus PCI or EGFR-TKI alone,stratified according to prior chemotherapy regimens (first line vs second line), and disease response status.
Group 1: Patients undergo prophylactic brain radiotherapy. Group 2: Patients undergo observation. Patients complete quality of life questionnaires periodically.
After completion of study therapy, patients are followed up periodically.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prophylactic cranial irradiation | Experimental | Radiation: Prophylactic cranial irradiation, Drug: Erlotinib /GefitinibPatients receive Erlotinib or gefitinib until disease progression or intolerable toxicity, and prophylactic cranial irradiation 25GY over 10 fractions. |
| Conctrol | Active comparator | Drug: Erlotinib /GefitinibPatients received Erlotinib or gefitinib until disease progression,or intolerable toxicity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients were required to have histologically or cytologically documented
- NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
- No previous history of radiotherapy and surgery of brain
- good response( CR/PR) to Erlotinib or Gefitinib.
- Agree to radiotherapy
Key exclusion criteria (3 listed)
- Seizure cannot be controled by the drugs
- Combined with other disease of the brain such as tumour or infarction
- Hypersensitivity to MR enhancer -
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 |
|---|---|---|
| Prophylactic cranial irradiationAlso: PCI25GY/10fraction | Radiation | prophylactic cranial irradiation |
| Erlotinib /GefitinibAlso: EGFR-TKIErlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity | Drug | Conctrol, prophylactic cranial irradiation |
Primary outcome
The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM)
Time frame: 2.5years
1 secondary outcome
overall survival
Time frame: baseline to date of death from any cause
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prophylactic cranial irradiation and Erlotinib /Gefitinib in people with Non-small Cell Lung Cancer, run by Zhejiang Cancer Hospital at 2 sites 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 8 inclusion and 3 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 8 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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 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?
The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) (time frame: 2.5years). 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 8 Jul 2010.