Carcinoma, Non-Small-Cell LungPhase 2NCT00466089
Study of 3D Radiotherapy With or Without Erlotinib (Tarceva®) in Patients With Localized Non-Small Cell Lung Cancer
A Phase 2 study testing Erlotinib (Tarceva®) in people with Carcinoma, Non-Small-Cell Lung, run by Hospital of Navarra at 5 sites in Spain.
Trial summary
A phase II, multicenter, randomized trial of 3D Radiotherapy versus 3D Radiotherapy and erlotinib (Tarceva®) in patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment, to compare safety and toxicity profile, and the progression-free survival in both arms of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Erlotinib (Tarceva®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesSpain
- Study dates
- Mar 2006to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent prior to any specific procedure of the protocol.
- Histologically confirmed diagnosis of non small cell lung cancer.
- Unresectable (IA-IIIB) non-small cell lung cancer.
- Patients non susceptible for chemotherapy treatment
- Measurable disease according to RECIST criteria
- Age > 18 years.
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- ECOG performance status < 2.
- Adequate bone marrow, hepatic, renal and respiratory function.
- Patients capable of following an adequate therapeutic compliance and accessible for a correct follow-up.
- Women at a fertile age must have a negative serum or urine pregnancy test within the 7 days prior to the beginning of the treatment.
- Patients of both genders at a fertile age, including those women having their last menstruation within the two previous years, must follow effective contraceptive measures.
Who cannot join
- Prior chemotherapy or radiotherapy.
- History of other curatively treated malignancy and no evidence of disease within the past 5 years except squamous cell skin cancer, or resected cervix carcinoma.
- Pregnant or lactating women.
- Any other severe disease or clinical conditions, as, but not only:
- Unstable cardiopathy despite treatment, myocardial infarction within the 6 months before entering the study
- Uncontrolled active infection
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- Uncontrolled peptic ulcer, unstable diabetes mellitus or any other contraindication for treatment with corticosteroids.
- Autoimmune diseases.
- Concomitant treatment with any other antineoplastic therapy.
- Prior experimental pharmacological agent within the 3 weeks prior to the inclusion of the study.
- Prior treatment with EGFR targeted therapies.
- Erlotinib known hypersensibility.
- Any radiotherapy treatment contraindication.
- History of significant neurological or psychiatric disorders, including epileptic seizures.
- Any significant ophthalmologic impairment of the eye surface (Use of contact lenses is not recommended)
- Inability to take oral medication and surgical procedures affecting the absorption or implying intravenous or parenteral feeding.
- Any other underlying severe process affecting the ability to take part in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites, 5 recruiting
- Recruiting
Hospital Clínic i Provincial de Barcelona
Barcelona, Barcelona, 08036
Nuria Viñolas, Dr.
Francesc Casas, Dr.
- Recruiting
Hospital de Donostia
Donostia / San Sebastian, San Sebastian, 20080
Julian Minguez, Dr.
- Recruiting
Hospital Puerta de Hierro
Madrid, Madrid, 28035
Alejandro De la Torre, Dr.
- Recruiting
Fundación Jimenez Diaz
Madrid, Madrid, 28040
Ana Mª Perez Casas, Dr.
- Recruiting
Hospital de Navarra
Pamplona, Navarre, 31008
Enrique Martinez, Dr.
About this study
Official title: Phase II Randomized Trial of 3D Radiotherapy Versus the Combination of 3D Radiotherapy and Erlotinib (Tarceva®) in Patients With Localized-Unresectable Non-Small Cell Lung Cancer Non Susceptible for Chemotherapy Treatment.
A phase II, multicenter, randomized trial of 3D Radiotherapy versus 3D Radiotherapy and erlotinib (Tarceva®) in patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment, to compare safety and toxicity profile, and the progression-free survival in both arms of treatment (3D Radiotherapy versus 3D Radiotherapy + erlotinib) in patients who have not received previous chemotherapy.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Erlotinib (Tarceva®)
- Keywords
- NSCLC, lung cancer, Patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment.
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib (Tarceva®)Drug
Erlotinib (Tarceva®), 150mg/day p.o during 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | RT + Tarceva Receives: Drug: Erlotinib (Tarceva®) |
| 2 | No intervention | RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determinate the viability and toxicity profile of Erlotinib + 3D Radiotherapy treatment (% of patients presenting toxicity 3-4 during the treatment).
Secondary outcomes (4)
The progression-free survival.
1-year survival.
Overall survival.
Objective response rate, according to RECIST criteria.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startMar 2006
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital of Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Enrique Martínez López
- Investigators
- Enrique Martínez, Dr., Principal investigator, Hospital de NavarraAna Mª Perez Casas, Dr., Principal investigator, Fundación Jimenez DiazAlejandro De la Torre, Dr., Principal investigator, Hospital Puerta de HierroFrancesc Casas, Dr., Principal investigator, Hospital Clínic i Provincial de BarcelonaNuria Viñolas, Dr., Principal investigator, Hospital Clínic i Provincial de BarcelonaJulian Minguez, Dr., Principal investigator, Hospital de Donostia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466089
- Sponsor's protocol ID
- MO19182
- Status last verified
- Nov 2007
- First submitted
- 25 Apr 2007
- Last updated
- 10 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Trial of 3D Radiotherapy Versus the Combination of 3D Radiotherapy and Erlotinib (Tarceva®) in Patients With Localized-Unresectable Non-Small Cell Lung Cancer Non Susceptible for Chemotherapy Treatment.
- ClinicalTrials.gov ID
- NCT00466089
- Acronym / sponsor ID
- MO19182
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- NSCLC, lung cancer, Patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital of NavarraUniversity, hospital or other
- Collaborators
- Dr. Enrique Martínez López
- Study start
- Mar 2006
- First posted
- 27 Apr 2007 (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.
A phase II, multicenter, randomized trial of 3D Radiotherapy versus 3D Radiotherapy and erlotinib (Tarceva®) in patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment, to compare safety and toxicity profile, and the progression-free survival in both arms of treatment (3D Radiotherapy versus 3D Radiotherapy + erlotinib) in patients who have not received previous chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Erlotinib (Tarceva®)RT + Tarceva |
| 2 | No intervention | –RT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent prior to any specific procedure of the protocol.
- Histologically confirmed diagnosis of non small cell lung cancer.
- Unresectable (IA-IIIB) non-small cell lung cancer.
- Patients non susceptible for chemotherapy treatment
- Measurable disease according to RECIST criteria
Key exclusion criteria (17 listed)
- Prior chemotherapy or radiotherapy.
- History of other curatively treated malignancy and no evidence of disease within the past 5 years except squamous cell skin cancer, or resected cervix carcinoma.
- Pregnant or lactating women.
- Any other severe disease or clinical conditions, as, but not only:
- Concomitant treatment with any other antineoplastic therapy.
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 (Tarceva®)Erlotinib (Tarceva®), 150mg/day p.o during 6 months. | Drug | 1 |
Primary outcome
To determinate the viability and toxicity profile of Erlotinib + 3D Radiotherapy treatment (% of patients presenting toxicity 3-4 during the treatment).
4 secondary outcomes
The progression-free survival.
1-year survival.
Overall survival.
Objective response rate, according to RECIST criteria.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2008.
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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.
Enrique Martínez, Dr. principal investigator
Hospital de Navarra
Ana Mª Perez Casas, Dr. principal investigator
Fundación Jimenez Diaz
Alejandro De la Torre, Dr. principal investigator
Hospital Puerta de Hierro
5 sites 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 (Tarceva®) in people with Carcinoma, Non-Small-Cell Lung, run by Hospital of Navarra at 5 sites in Spain.
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 11 inclusion and 17 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 10 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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 Enrique Martinez, Dr. (00 34 848 42 22 22 ext. 2161, enrique.martinez.lopez@cfnavarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determinate the viability and toxicity profile of Erlotinib + 3D Radiotherapy treatment (% of patients presenting toxicity 3-4 during the treatment).. 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 10 Jan 2008.