Androgen Deprivation Therapy in Advanced Salivary Gland Cancer
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|ClinicalTrials.gov Identifier: NCT01969578|
Recruitment Status : Unknown
Verified July 2020 by European Organisation for Research and Treatment of Cancer - EORTC.
Recruitment status was: Recruiting
First Posted : October 25, 2013
Last Update Posted : July 31, 2020
Salivary Gland (SG) Cancers are a rare and heterogeneous group of tumors, usually approached by multidisciplinary teams in high specialized centers. Until today no standard of care exists to treat these cancers. The identification of a target, the androgen receptor, in SG tumors has allowed for new treatment strategies options for this rare group of diseases. As a matter of fact, strong positivity for androgen expression has been found in salivary duct carcinoma and adenocarcinomas. The purpose of this study is therefore to evaluate the efficacy and safety of chemotherapy versus androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic AR expressing SGCs.
The study will include two cohorts of patients: Cohort A, which comprises chemo-naïve patients, and Cohort B, which comprises pretreated patients.
|Condition or disease||Intervention/treatment||Phase|
|Salivary Gland Cancer||Drug: bicalutamide + triptorelin Drug: Cisplatin + Doxorubicin Drug: Carboplatin + Paclitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Active Comparator: Chemotherapy
Chemotherapy = either Cisplatin + Doxorubicin or Carboplatin + Paclitaxel
Patients from cohort A (chemonaïve) may be randomized in this arm to receive chemotherapy
Drug: Cisplatin + Doxorubicin
Drug: Carboplatin + Paclitaxel
Experimental: Androgen Deprivation Therapy (ADT)
ADT = bicalutamide + triptorelin
Patients from cohort A (chemonaive) may be randomized to receive ADT, and patients from cohort B (pre-treated) will receive ADT without having been randomized.
Drug: bicalutamide + triptorelin
- Progression Free Survival (PFS) [ Time Frame: 37 months after First Patient In ]PFS is a primary outcome for cohort A
- Response rate (RR) [ Time Frame: 37 months after First Patient In ]RR is a primary outcome for cohort B
- Response Rate (RR) [ Time Frame: 37 months after First Patient In ]RR is a secondary outcome for cohort A
- Progression Free Survival (PFS) [ Time Frame: 37 months after First Patient In ]PFS is a secondary outcome for cohort B
- Overall Survival (OS) [ Time Frame: 37 months after First Patient In ]
- Adverse Events according to CTCAE v4.0 [ Time Frame: 37 months after First Patient In ]adverse events will be recorded using International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all adverse events
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): NCT01969578
|Contact: EORTC HQ||+32 2 774 email@example.com|
|Principal Investigator:||Lisa Licitra||Fondazione IRCCS ISTITUTO NAZIONALE TUMORI|
|Study Chair:||Kevin Harrington||The Royal Marsden|