Trial · NCT03083678
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median PFS according to RECIST 1.1 criteria on afatinib treatment (first-line cohort) | From date of start treatment until date of first documented of progression or withdrawal (through study completion, an average of 1 year). | The objective is to increase the median PFS ≥ 12 months in first-line treatment cohort. |
| Primary | Median PFS according to RECIST 1.1 criteria on afatinib treatment (second or later line cohort) | From date of start treatment until date of first documented of progression or withdrawal (through study completion, an average of 1 year). | The objective is to increase the median PFS ≥ 9 months in later-line treatment cohort. |
| Primary | Quality of life assessment by EORTC QLC-30 questionnaire. | From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year). | Change from baseline in EORTC QLC-30 questionnaire score. |
| Primary | Quality of life assessment by Brief pain inventory short form | From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year). | Change from baseline on Brief pain inventory short form score. |
| Secondary | Growth modulation index. | From date of start treatment until date of first documented of progression (through study completion, an average of 1 year). | Time to progression during afatinib treatment (TTP2) divided by time to progression before start of this treatment TTP1 (= growth modulation index) |
| Secondary | Toxicity determined by CTCAE v 4.03 criteria | From date of start treatment until date of first documented of progression or withdrawal (through study completion, an average of 1 year). | Toxicity determined by CTCAE v 4.03 criteria |
| Secondary | Overall survival. | Survival follow-up after end of treatment every 3 months for up to 2 years followed by contact at 3 years. | Overall survival from start of afatinib treatment |
| Other | Translational research - EGFR pathway analysis in tumor tissue | From date of inclusion until date of first documented of progression or withdrawal (through study completion, an average of 1 year) | EGFR status by FISH / immunohistochemistry |
| Other | Translational research - Genome sequence analysis of available tumor samples | From date of inclusion until date of first documented of progression or withdrawal (through study completion, an average of 1 year) | Genetic mutations by DNA whole genome sequencing of fresh samples |
| Other | Translational research - circulating tumor DNA | Analysis on blood samples to be taken at baseline, cycle 4 day 1, cycle 7 day 1 and at end of treatment (within 30 days after last dose of study drug). | Circulating chordoma tumor DNA identification by WGS and PCR |
| Other | Translational research - circulating exosomes | Analysis on blood samples to be taken at different time points on cycle 1 day 1, cycle 1 day 15, cycle 3 day 1 and cycle 5 day 1. | Circulating exosomes identification by PCR |
| Other | Pharmacokinetic research | Analysis on blood samples to be taken at different time points on cycle 1 day 1, cycle 1 day 15, cycle 3 day 1 and cycle 5 day 1. | Area under the curve |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03083678/registered