A randomized phase II study to evaluate the efficacy and safety of chemotherapy (CT) vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancer (SGCs)
Phase 2
Recruiting
- Conditions
- salivary duct carcinoma10072990
- Registration Number
- NL-OMON54823
- Lead Sponsor
- European Organisation for Research in Treatment of Cancer (EORTC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1
Inclusion Criteria
-Histologically proven diagnosis of recurrent and/or metastatic salivary duct
cancer; adenocarcinoma NOS; and AR expression level of =6 in nuclei of
neoplastic cells based on central review
-Presence of at least one uni-dimensional measurable lesion by CT-scan or MRI
according to RECIST criteria version 1.1 (target lesion).
-Patients older than 18 years old;
-Performance Status ECOG 0-1;
Exclusion Criteria
-active second malignancy during the last five years
-Patients who received vaccine for yellow fever
-cardiac abnormalities
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Cohort A (treatment naïve patients):<br /><br>Progression-Free Survival according to Response Evaluation Criteria In Solid<br /><br>Tumors (RECIST) criteria version 1.1 and/or Prostate Cancer<br /><br>Clinical Trials Working Group (PCWG2) (2007) for bone lesions, or death,<br /><br>whichever comes first.<br /><br><br /><br>Cohort B (pretreated patients):<br /><br>Best Overall Response defined according to RECIST v 1.1.</p><br>
- Secondary Outcome Measures
Name Time Method <p>For treatment-naïve patients:<br /><br>- Best Overall Response defined according to RECIST v 1.1<br /><br>- Overall Survival<br /><br>- Toxicity<br /><br>For pre-treated patients:<br /><br>- Progression Free Survival<br /><br>- Overall Survival<br /><br>- Toxicity</p><br>