Clinical Trial: Dopamine Agonists Withdrawal Study of Invasive Prolactinomas Involving the Cavernous Sinus

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Dopamine Agonists Withdrawal Study of Invasive Prolactinomas Involving the Cavernous Sinus

Brief Summary: The purpose of this study is to observe whether dopamine agonists can be safely withdrawn after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous sinus have been effectively controlled through pharmacological treatment.

Detailed Summary: For giant or large invasive prolactinomas involving the cavernous sinus, whether the drug can be safely withdrawn after the tumor volume and prolactin(PRL) level have been effectively controlled through pharmacological treatment still remains unknown. The study objects are patients with invasive prolactinomas involving the cavernous sinus, which were invaded the cavernous sinus to an extent corresponding to Grade III or IV, according to the classification scheme of Knosp and colleagues, who had undergone pharmacological treatment including bromocriptine or cabergoline. Observation will be started after drug withdrawal criteria are reached (PRL remains normal level for no less than two years; tumor volume has shrank more than 50%, and the distance is more than 5mm between tumor and optical nerve),the patients are randomized to withdrawal group or continue treatment group.Observational items include changes of PRL level, tumor volume as well as vision acuity and visual fields. If elevated PRL or tumor relapse is observed, pharmacological treatment will be restarted.
Sponsor: Zhebao Wu

Current Primary Outcome: Change from baseline on PRL level [ Time Frame: Up to 2 years ]

Record the result of PRL on every 3 month follow-up visit


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI） [ Time Frame: Up to 2 years ]
    Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits
  • Change from baseline of visual acuity [ Time Frame: Up to 2 years ]
    Record the Visual acuity on every 3 month follow-up visit
  • Change from baseline on 5 point visual field scale [ Time Frame: Up to 2 years ]
    Record the Visual field scale on every 3 month follow-up visit, 0 = normal, no vision loss; 1 = one quadrant vision loss; 2 = two quadrants of vision loss; 3 = three quadrants of vision loss; 4 = four quadrants of vision loss but retain a central tubular vision; 5 = blind


Original Secondary Outcome:

  • Change from baseline on tumor volume from enhanced pituitary Magnetic Resonance Imaging（MRI） [ Time Frame: Up to 2 years ]
    Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits
  • Change from baseline of visual acuity [ Time Frame: Up to 2 years ]
    Record the Visual acuity on every 3 month follow-up visit
  • Change from baseline on 5 point visual field scale [ Time Frame: Up to 2 years ]
    Record the Visual field scale on every 3 month follow-up visit, 0 = normal, no vision loss; 1 = one quadrant vision loss; 2 = two quadrants of vision loss; 3 = three quadrants of vision loss; 4 = four quadrants of vision loss but retain a central tubular vision; 5 = blind


Information By: Ruijin Hospital

Dates:
Date Received: August 15, 2015
Date Started: June 2016
Date Completion:
Last Updated: May 15, 2017
Last Verified: May 2017