Lung CancerPhase 3NCT00955695
Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer
A Phase 3 study testing erlotinib hydrochloride, gefitinib and questionnaire administration in people with Lung Cancer, run by National Cancer Center, Korea.
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 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- erlotinib hydrochloride, gefitinib and questionnaire administration
- Type of treatment
- Surgery or procedure
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- May 2009to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer
- Stage IIIB or IV disease
- Must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy
- At least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride
- Stable disease allowed provided 1 of the following criteria is met:
- EGFR mutation (exon 19 or 21)
- Having ≥ 2 of the following 3 factors:
- Female
- Never smoked
- Histologically confirmed adenocarcinoma of the lung
- No evidence of brain metastases by CT scan or MRI within the past 4 weeks
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 150,000/mm^3
- Bilirubin < 1.5 mg/dL
- Serum creatinine < 1.5 times upper limit of normal
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Received 1 or 2 prior systemic chemotherapy regimens
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 Nonprogressive on Gefitinib or Erlotinib
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 are stratified according to prior chemotherapy regimens (first line vs second line), and disease response status (complete response or partial response vs stable disease). Patients are randomized to 1 of 2 treatment groups.
- Group 1: Patients undergo prophylactic brain radiotherapy.
- Group 2: Patients undergo observation. Patients complete quality of life (HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20) questionnaires periodically.
After completion of study therapy, patients are followed up periodically.
- Conditions
- Lung Cancer
- Being tested
- erlotinib hydrochloride, gefitinib, questionnaire administration, quality-of-life assessment, whole-brain radiation therapy
- Keywords
- adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinib hydrochlorideDrug
gefitinibDrug
questionnaire administrationOther
quality-of-life assessmentProcedure or surgery
whole-brain radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to symptomatic brain metastases
Secondary outcomes (5)
Progression-free survival
Overall survival
Safety and tolerability of prophylactic cranial radiotherapy
Psycho-neurological effects of prophylactic cranial radiotherapy
Quality of life as measured by HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20 questionnaires periodically
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- Chang Geol Lee, MD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955695
- Sponsor's protocol ID
- KROG-4-2008-0276
- Other IDs
- CDR0000639096
- Status last verified
- Jan 2010
- First submitted
- 7 Aug 2009
- Last updated
- 2 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. 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 Nonprogressive on Gefitinib or Erlotinib
- ClinicalTrials.gov ID
- NCT00955695
- Acronym / sponsor ID
- KROG-4-2008-0276
- Conditions
- Lung Cancer
- Keywords
- adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- May 2009
- First posted
- 10 Aug 2009 (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 are stratified according to prior chemotherapy regimens (first line vs second line), and disease response status (complete response or partial response vs stable disease). Patients are randomized to 1 of 2 treatment groups.
- Group 1: Patients undergo prophylactic brain radiotherapy.
- Group 2: Patients undergo observation. Patients complete quality of life (HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20) questionnaires periodically.
After completion of study therapy, patients are followed up periodically.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| erlotinib hydrochloride | Drug | – |
| gefitinib | Drug | – |
| questionnaire administration | Other | – |
| quality-of-life assessment | Procedure or surgery | – |
| whole-brain radiation therapy | Radiation | – |
Primary outcome
Time to symptomatic brain metastases
5 secondary outcomes
Progression-free survival
Overall survival
Safety and tolerability of prophylactic cranial radiotherapy
Psycho-neurological effects of prophylactic cranial radiotherapy
Quality of life as measured by HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20 questionnaires periodically
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Chang Geol Lee, MD principal investigator
Yonsei University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing erlotinib hydrochloride, gefitinib and questionnaire administration in people with Lung Cancer, run by National Cancer Center, Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Time to symptomatic brain metastases. 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 2 Aug 2013.