Carcinoma, Non-Small-Cell LungPhase 3NCT00268684
Comparison Study of WBRT and SRS Alone Versus With Temozolomide or Erlotinib in Patients With Brain Metastases of NSCLC
A Phase 3 study testing Erlotinib, Temozolomide in people with Carcinoma, Non-Small-Cell Lung and Neoplasm Metastasis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The objectives of the study is to determine if either temozolomide or erlotinib combined with WBRT and SRS improves survival as compared to WBRT and SRS alone.Ptients with histologically confirmed NSCLC with the presence of 1-3 intraparenchymal brain metastases will be randomized to 3 arms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
- What is being tested?
- Erlotinib, Temozolomide
- How many people
- 381 participants
- Where
- 1 siteIsrael
- Study dates
- May 2005to 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
Who may be able to join
- Histologically confirmed non-small cell lung cancer with the presence of 1-3 intraparenchymal brain metastases.
- A contrast-enhanced MRI demonstrating the presence of 1-3 brain metastases performed within two weeks prior to registration.
- The contrast-enhancing intraparenchymal brain tumor must be well circumscribed and must have a maximum diameter of ≤ 4.0 cm in any direction on the enhanced scan. If multiple lesions are present and one lesion is at the maximum diameter, the other(s) must not exceed 3.0 cm in maximum diameter.
- Patients who present with symptoms of brain metastases at the time of initial diagnosis are eligible and do not need to demonstrate one month of stable scans.
- Age 18 years or older.
- Zubrod 0-1
Show all 13Show fewer
- Neurologic Function Status 0, 1, or 2.
- Patients may have stable extracranial metastases.
- Contrast-enhancing CT scans of the chest, abdomen and pelvis, and bone scan to determine the extent of extracranial malignant disease.
- Adequate bone marrow reserve
- Patients randomized to receive erlotinib who are on enzyme inducing seizure medicines including phenytoin, carbamazepine, rifampicin, barbiturates must be converted to a nonenzyme inducing anti-seizure medication. Patients on Arm 3 will not be able to start treatment immediately if converting.
- Patient must sign a study-specific informed consent form. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative.
- -
Who cannot join
- Major medical illnesses or psychiatric impairment
- Patients who have undergone a complete resection of all known brain metastases.Patients who have undergone subtotal resection are eligible providing residual disease is =/< 4.0 cm in maximum diameter.
- Inability to obtain histologic proof of NSCLC.
- Patients with leptomeningeal metastases documented by MRI or CSF evaluation.
- Clinical or radiographic evidence of progression (other than the study lesion(s)) within one month prior to enrollment. (Patients who have brain metastases at initial presentation are eligible and do not need to demonstrate one month of stable scans).
- Patients with metastases within 10 mm of the optic apparatus so that some portion of the optic nerve or chiasm would be included in the high dose SRS boost field.
Show all 15Show fewer
- Patients with metastases in the brainstem, midbrain, pons, or medulla.
- Patients with liver metastases.
- Previous cranial radiation.
- Women who are pregnant or nursing
- Patients who are HIV positive are not eligible.
- Any evidence of clinically active interstitial lung disease
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of studytreatment.
- Concomitant use of St. John's Wort.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib and temozolomide.
Trial locations and contacts
1 site in 1 country.
Lina Veisenman contact
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 63409
Felix Bokstein, M.D., 972-524266532, fbok@netvision.net.il
Debora Blumenthal, M.D., 972-524266403, dvorab@tasmc.gov.il
About this study
Official title: A Phase III Trial Comparing Whole Brain Radiation (WBRT) and Stereotactic Radiosurgery (SRS) Alone Versus With Temozolomide or Erlotinib in Patients With Non-Small Cell Lung Cancer and 1-3 Brain Metastases
The objectives of the study is to determine if either temozolomide or erlotinib combined with WBRT and SRS improves survival as compared to WBRT and SRS alone.Ptients with histologically confirmed NSCLC with the presence of 1-3 intraparenchymal brain metastases will be randomized to 3 arms. All of the patients will receive WBRT and SRS. The patients of the arm 1 will receive radiation treatment only, the arm 2 patients will be treated with temozolomide and arm 3 patients will receive erlotinib
- Being tested
- Erlotinib, Temozolomide
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib, TemozolomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Enrolment
- 381 participants
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Radiation Therapy Oncology Group
- Investigators
- Felix Bokstein, M.D., Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268684
- Sponsor's protocol ID
- TASMC-05-FB-05235-CTIL
- Status last verified
- Dec 2005
- First submitted
- 21 Dec 2005
- Last updated
- 28 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial Comparing Whole Brain Radiation (WBRT) and Stereotactic Radiosurgery (SRS) Alone Versus With Temozolomide or Erlotinib in Patients With Non-Small Cell Lung Cancer and 1-3 Brain Metastases
- ClinicalTrials.gov ID
- NCT00268684
- Acronym / sponsor ID
- TASMC-05-FB-05235-CTIL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 381 participants
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Radiation Therapy Oncology Group
- Study start
- May 2005
- First posted
- 22 Dec 2005 (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 objectives of the study is to determine if either temozolomide or erlotinib combined with WBRT and SRS improves survival as compared to WBRT and SRS alone.Ptients with histologically confirmed NSCLC with the presence of 1-3 intraparenchymal brain metastases will be randomized to 3 arms. All of the patients will receive WBRT and SRS. The patients of the arm 1 will receive radiation treatment only, the arm 2 patients will be treated with temozolomide and arm 3 patients will receive erlotinib
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed non-small cell lung cancer with the presence of 1-3 intraparenchymal brain metastases.
- A contrast-enhanced MRI demonstrating the presence of 1-3 brain metastases performed within two weeks prior to registration.
- The contrast-enhancing intraparenchymal brain tumor must be well circumscribed and must have a maximum diameter of ≤ 4.0 cm in any direction on the enhanced scan. If multiple lesions are present and one lesion is at the maximum diameter, the other(s) must not exceed 3.0 cm in maximum diameter.
- Patients who present with symptoms of brain metastases at the time of initial diagnosis are eligible and do not need to demonstrate one month of stable scans.
- Age 18 years or older.
Key exclusion criteria (15 listed)
- Major medical illnesses or psychiatric impairment
- Patients who have undergone a complete resection of all known brain metastases.Patients who have undergone subtotal resection are eligible providing residual disease is =/< 4.0 cm in maximum diameter.
- Inability to obtain histologic proof of NSCLC.
- Patients with leptomeningeal metastases documented by MRI or CSF evaluation.
- Clinical or radiographic evidence of progression (other than the study lesion(s)) within one month prior to enrollment. (Patients who have brain metastases at initial presentation are eligible and do not need to demonstrate one month of stable scans).
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, Temozolomide | Drug | – |
Primary outcome
survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2006.
Related trials for Carcinoma, Non-Small-Cell Lung
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
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
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, 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.
Lina Veisenman contact
Felix Bokstein, M.D. principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erlotinib, Temozolomide in people with Carcinoma, Non-Small-Cell Lung and Neoplasm Metastasis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 13 inclusion and 15 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 28 Feb 2006. 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 Israel. 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 Lina Veisenman (972-36977285), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival. 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 28 Feb 2006.