EGFR-mutated Lung AdenocarcinomaARPEGENCT01363557
Assess the Efficacy of Whole Brain Radiation Therapy in Lung Cancer Patients With Brain Metastasis
A study testing whole brain radiotherapy and Gefitinib (IRESSA) in people with EGFR-mutated Lung Adenocarcinoma and Brain Metastasis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Multicentre randomised (1:1) trial assessing the efficacy of whole brain radiotherapy in addition to Gefitinib for the management of brain metastasis in lung cancer patients with a mutated EGFR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR-mutated Lung Adenocarcinoma, Brain Metastasis
- What is being tested?
- whole brain radiotherapy and Gefitinib (IRESSA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to May 2013
- Phase
- Interventional
- 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
Who may be able to join
- Patients must have signed a written informed consent form prior to any study specific screening procedures
- 18 years or older
- KPS ≥ 50%
- Histologically confirmed adenocarcinoma of the lung
- Activating mutation of EGFR
- Newly diagnosed CNS metastasis or in progression with at least one measurable lesion in the brain (defined as any lesion > 1 cm on T1-weighted contrast enhanced MRI)
Show all 9Show fewer
- Patients could enter the study regardless of previous treatment (included chemotherapy) for metastatic extracranial disease, except TKI.
- No steroids or stable or decreasing dose of steroids for at least 5 days before the MRI evaluation.
- Adequate hematologic, liver and renal functions: neutrophil count ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; Hb ≥ 9 g/Dl; Total bilirubin < 1.5 x ULN; AST or ALT < 2.5 x ULN (< 5 x ULN in patients with liver metastases); Serum creatinine ≤ 1.5 x ULN or Creatinine clearance ≥ 50 mL/min
Who cannot join
- Prior treatment of brain metastases with WBRT or TKI
- Patient eligible for radiosurgery or surgical resection
- Contre indication at the radiotherapy
- Leptomeningeal disease
- Previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in-situ carcinoma of the cervix) within the the 5 years before study entry
- Prior treatment with Gefitinib or other TKI
- Pregnant or breast feeding women
- Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective means of contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized to Assess the Efficacy of Whole Brain Radiation Therapy (WBRT) With Concomitant Gefitinib Followed by Maintenance Gefitinib, and Gefitinib Alone, in Lung Cancer Patients With Brain Metastasis
Multicentre randomised (1:1) trial assessing the efficacy of whole brain radiotherapy in addition to Gefitinib for the management of brain metastasis in lung cancer patients with a mutated EGFR.
Read the detailed description
Lung cancer patients with newly diagnosed CNS metastasis with- at least one brain lesion measuring > 1 cm in longest dimension - not eligible for surgery or stereotactic radio-surgeryOpen-label, multicentre, national, randomised (1:1) phase II trialArm A: WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance Arm B: Gefitinib
- Conditions
- EGFR-mutated Lung Adenocarcinoma, Brain Metastasis
- Being tested
- whole brain radiotherapy, Gefitinib (IRESSA)
- Keywords
- Randomized, Brain Radiation Therapy, Lung Cancer, Brain Metastasis, Gefitinib
- Medical subject headings
- Brain Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole brain radiotherapyOther
External beam RT using a total dose of 30 Gy with ten daily fractions of 3.0 Gy given 5 days per week over 2 weeks + Gefitinib 250 mg/day
Gefitinib (IRESSA)Drug
250 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Arm A : Gefitinib + WBRT | Experimental | Arm A : WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance Receives: Other: whole brain radiotherapy |
| Arm B : Gefitinib | Experimental | Arm B : Gefitinib alone Receives: Drug: Gefitinib (IRESSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the objective response rate of brain metastases in each arm
Measured: at 6 weeks
Secondary outcomes (3)
Number of Participants with neurological Adverse Events
Measured: at 6 weeks, 3 months, 4.5 months and 6 months
Progression-free survival (PFS)
Measured: at 6 months
Overall survival
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionMay 2013
Why it stopped: Decision of Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR-mutated Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Antoine CARPENTIER, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363557
- Sponsor's protocol ID
- P100601
- Other IDs
- 2010-A01332-37
- Acronym
- ARPEGE
- Status last verified
- May 2014
- First submitted
- 25 May 2011
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized to Assess the Efficacy of Whole Brain Radiation Therapy (WBRT) With Concomitant Gefitinib Followed by Maintenance Gefitinib, and Gefitinib Alone, in Lung Cancer Patients With Brain Metastasis
- ClinicalTrials.gov ID
- NCT01363557
- Acronym / sponsor ID
- ARPEGE / P100601
- Conditions
- EGFR-mutated Lung Adenocarcinoma, Brain Metastasis
- Keywords
- Randomized, Brain Radiation Therapy, Lung Cancer, Brain Metastasis, Gefitinib
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision of Sponsor
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 1 Jun 2011 (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.
Multicentre randomised (1:1) trial assessing the efficacy of whole brain radiotherapy in addition to Gefitinib for the management of brain metastasis in lung cancer patients with a mutated EGFR.
Detailed description
Lung cancer patients with newly diagnosed CNS metastasis with- at least one brain lesion measuring > 1 cm in longest dimension - not eligible for surgery or stereotactic radio-surgeryOpen-label, multicentre, national, randomised (1:1) phase II trialArm A: WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance Arm B: Gefitinib
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A : Gefitinib + WBRT | Experimental | Other: whole brain radiotherapyArm A : WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance |
| Arm B : Gefitinib | Experimental | Drug: Gefitinib (IRESSA)Arm B : Gefitinib alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have signed a written informed consent form prior to any study specific screening procedures
- 18 years or older
- KPS ≥ 50%
- Histologically confirmed adenocarcinoma of the lung
- Activating mutation of EGFR
Key exclusion criteria (8 listed)
- Prior treatment of brain metastases with WBRT or TKI
- Patient eligible for radiosurgery or surgical resection
- Contre indication at the radiotherapy
- Leptomeningeal disease
- Previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in-situ carcinoma of the cervix) within the the 5 years before study entry
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 |
|---|---|---|
| whole brain radiotherapyExternal beam RT using a total dose of 30 Gy with ten daily fractions of 3.0 Gy given 5 days per week over 2 weeks + Gefitinib 250 mg/day | Other | Arm A : Gefitinib + WBRT |
| Gefitinib (IRESSA)250 mg/day | Drug | Arm B : Gefitinib |
Primary outcome
To assess the objective response rate of brain metastases in each arm
Time frame: at 6 weeks
3 secondary outcomes
Number of Participants with neurological Adverse Events
Time frame: at 6 weeks, 3 months, 4.5 months and 6 months
Progression-free survival (PFS)
Time frame: at 6 months
Overall survival
Time frame: at 6 months
Results and safety
The study was stopped early (reason given: Decision of Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
Related trials for EGFR-mutated Lung Adenocarcinoma
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Active, not recruitingObservational study
SERS-Based Diagnosis of Leptomeningeal Metastasis in EGFR-Mutant NSCLC
Lung Adenocarcinoma EGFR-mutated, Leptomeningeal Metastasis From Lung Cancer
RecruitingPhase 2
Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma
NSCLC, EGFR Positive Non-small Cell Lung Cancer
Not yet recruitingPhase 2
Firmonertinib Plus Chemotherapy for Unresectable EGFR PACC-Mutant Stage III Lung Cancer: A Phase II Study
Lung Adenocarcinoma, Stage III Lung Cancer
RecruitingPhase 1/2
Amivantamab Combined With Intrathecal Pemetrexed for LM From EGFR-Mutated Lung Adenocarcinoma
Leptomeningeal Metastasis From 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.
Antoine CARPENTIER, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole brain radiotherapy and Gefitinib (IRESSA) in people with EGFR-mutated Lung Adenocarcinoma and Brain Metastasis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 13 May 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 France. 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.
Are results available for this study?
The study was stopped early (reason given: Decision of Sponsor). 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?
To assess the objective response rate of brain metastases in each arm (time frame: at 6 weeks). 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 13 May 2014.