The two main objectives of the study are:* To assess the efficacy of ADT in treatment naïve patients with recurrent and/or metastatic, androgen receptor (AR) expressing, SGCs. The primary measure of efficacy is Progression-Free Survival (PFS).* To…
ID
Source
Brief title
Condition
- Soft tissue neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cohort A (treatment naïve patients):
Progression-Free Survival according to Response Evaluation Criteria In Solid
Tumors (RECIST) criteria version 1.1 and/or Prostate Cancer
Clinical Trials Working Group (PCWG2) (2007) for bone lesions, or death,
whichever comes first.
Cohort B (pretreated patients):
Best Overall Response defined according to RECIST v 1.1.
Secondary outcome
For treatment-naïve patients:
- Best Overall Response defined according to RECIST v 1.1
- Overall Survival
- Toxicity
For pre-treated patients:
- Progression Free Survival
- Overall Survival
- Toxicity
Background summary
Salivary Gland Cancer (SGC) are rare tumors that comprise less than 5% of all
cancers of the head and neck. The subtype of SGC in this study, expresses
androgen receptors (AR) on the cell surface, which can be used as a therapy
treatment. The anti-androgen treatment (treatment directed against the AR) in
this study is a combination of two agents: bicalutamide and triptorelin. This
combination is the standard treatment of prostate cancer with expression of AR.
In this study we compare the effects of anti-androgen therapy with chemotherapy
to investigate which treatment shows the best results. In this study we also
examine various mechanisms at the cellular level which may explain why the
tumor is or is not responding to treatment.
Study objective
The two main objectives of the study are:
* To assess the efficacy of ADT in treatment naïve patients with recurrent
and/or metastatic, androgen receptor (AR) expressing, SGCs. The primary measure
of efficacy is Progression-Free Survival (PFS).
* To describe the effect of ADT in pretreated patients with recurrent and/or
metastatic, AR expressing SGCs. The main measure of efficacy is response to
treatment.
Study design
Approximately 220 patients will participate in Europe, Based on their previous
treatment, patients will be allocated to one of the two groups of study.
Patients who previously had chemotherapy will receive anti-androgen treatment.
The patients who had not been treated before will be randomized between
anti-androgen treatment or standard chemotherapy. This standard chemotherapy
may be cisplatin together with carboplatin or doxorubicin together with
paclitaxel. The chemotherapy will be administered for up to 6 cycles or until
tumor growth or the occurrence of limiting side effects.
lf a patient has received chemotherapy and the tumor is progressive, it can be
switched to anti-androgen therapy.
Intervention
Patients who previously had chemotherapy will receive anti-androgen treatment.
The patients who had not been treated before will be randomized between
anti-androgen treatment or standard chemotherapy. This standard chemotherapy
may be cisplatin together with carboplatin or doxorubicin together with
paclitaxel.
Study burden and risks
This research may lead to new treatment options for patients with salivary
gland cancer with metastases or local recurrence of the disease. In addition,
this study results in new information that may lead to new tools for further
research.
Because most of all investigation are part of the normal practice, the extend
of the burden for the patients will be minimal.
Avenue Emmanuel Mounier 83/11
Brussels 1200
BE
Avenue Emmanuel Mounier 83/11
Brussels 1200
BE
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-000314-38-NL |
| ClinicalTrials.gov | NCT01969578 |
| CCMO | NL51577.091.14 |