Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer (ELAN-UNFIT)
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|ClinicalTrials.gov Identifier: NCT01884623|
Recruitment Status : Active, not recruiting
First Posted : June 24, 2013
Last Update Posted : August 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Head Neck Cancer Squamous Cell Recurrent||Drug: Cetuximab Drug: Methotrexate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicentric Randomized Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer in Elderly Unfit Patients According to Geriatric Evaluation|
|Actual Study Start Date :||November 6, 2013|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||August 2023|
Dosing schedule: 500 mg/m², every two weeks (q2w) Mode of administration: IV
Active Comparator: Methotrexate
Dosing schedule: 40mg/m2 weekly (q1w) Mode of administration: IV
- Failure free survival (FFS) [ Time Frame: From randomization to the first event among progression, treatment stop, whatever the cause, loss of 2 points or more in ADL scale and death assessed up to 16 months ]Composite criteria of efficacy and tolerance: Failure free survival (FFS) defined as time from randomization to the first event among progression (defined by RECIST criteria), treatment stop (whatever the cause), loss of 2 points or more in Activities in Daily Living (ADL) scale and death (whatever the cause). Patients who don't have any of these events are censored at the date of last follow-up.
- Overall survival (OS) [ Time Frame: From randomization to death from any cause assessed up to 1 months ]Patients with disease progression will be treated off protocol but will be followed for overall survival evaluation.
- Progression free survival (PFS) [ Time Frame: From randomization to progression assessed up to 16 months ]minimum time from randomization to progression as defined by RECIST criteria or to death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884623
|Institut Gustave Roussy|
|Villejuif, Val De Marne, France, 94805|
|Study Chair:||Joel GUIGAY, Pr||Gustave Roussy, Cancer Campus, Grand Paris|