Androgen Deprivation Therapy in Advanced Salivary Gland Cancer

What Was Tested

The trial (phase 2) is built around Triptorelin.

It had two arms (groups): Chemotherapy (active comparator) and Androgen Deprivation Therapy (ADT) (experimental).

Chemotherapy = either Cisplatin + Doxorubicin or Carboplatin + Paclitaxel Patients from cohort A (chemonaïve) may be randomized in this arm to receive chemotherapy.

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.

The registry classes the interventions as drug.

More on the Plan

Patients of Cohort A randomized to the control arm (chemotherapy arm) will be given the option to enter Cohort B at the time of disease progression.

As long as Cohort A is open to recruitment, patients who will be treated by chemotherapy will be simultaneously enrolled in Cohort B.

Accrual in Cohort B will be stopped when recruitment of 76 eligible patients in Cohort A is reached.

Who Took Part

The registry lists 149 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Sufficient tissue must be available either historically or a biopsy must be done as a part of this study and sent to central review for patients enrolled in both cohorts. 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;. Adequate bone marrow function:.

The full record lists 19 inclusion and 15 exclusion criteria; among the exclusions: actively bleeding tumor if the patient is intended to be treated with carboplatin; history of allergic reactions attributed to compounds of similar chemical or biological composition to cis/carboplatin, paclitaxel, doxorubicin, bicalutamide or triptorelin;; concomitant medications with terfenadine, astemizole, cisaprid.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Triptorelin and who got the comparison, which limits bias.

The Triptorelin group and the comparison group ran side by side rather than switching.

Being open-label, the Triptorelin study did not mask who received what.

It started in 2015-09-24 with completion listed for 2023-08-23.

It ran at 26 sites in France (9), Belgium (5), Germany (3), Italy (3), Netherlands (3) and Austria (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Progression Free Survival (PFS) (time frame: 37 months after First Patient In). Response rate (RR) (time frame: 37 months after First Patient In).

It also tracked 2 secondary outcomes, for example Response Rate (RR) and Progression Free Survival (PFS).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Triptorelin in 149 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, all human trials.