Clinical trial NCT02536261: Dopamine Agonists Withdrawal Study of Invasive Prolactinomas Involving the Cavernous Sinus
Official title: Dopamine Agonists Withdrawal Study of Invasive Prolactinomas Involving the Cavernous Sinus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Invasive Prolactinomas Involving the Cavernous Sinus
Keywords: Prolactinoma
dopamine agonist
withdrawal
cavernous sinus
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Xinqiao Hospital of Chongqing
name: First Hospital of China Medical University
name: Beijing Tiantan Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: First Affiliated Hospital of Fujian Medical University
name: Peking Union Medical College Hospital
name: Huashan Hospital
First posted: 2015-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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Brief summary: The purpose of this study is to observe whether dopamine agonists can be safely withdrawn after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous sinus have been effectively controlled through pharmacological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 description: For giant or large invasive prolactinomas involving the cavernous sinus, whether the drug can be safely withdrawn after the tumor volume and prolactin(PRL) level have been effectively controlled through pharmacological treatment still remains unknown.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.

Eligibility criteria: Inclusion Criteria:

1. Aged between 15 and 70 years old, either sex;
2. Karnofsky performance status ≥ 70;
3. Patients who were suffered Invasive prolactinomas involving the cavernous sinus , referring to ①Serum prolactin level\>200ng/ml, or \>4000mIU/L;②enhanced Magnetic Resonance images confirm tumor invasion into cavernous sinus, i.e. Knosp grade Ⅲ or Ⅳ, and were treated by dopamine agonists treatment;
4. PRL remains normal level for no less than two years;
5. Tumor volume has shrank more than 50%, and the distance is more than 5mm between tumor and optical nerve;
6. The patient has signed the informed consent.

Exclusion Criteria:

1. Patients concomitantly taking the psychotropic drugs or other drugs causing elevated PRL ;
2. Patients with parkinson disease and is taking dopaminergic agents;
3. Patients with prolactinoma who received Gamma knife treatment;
4. Patients who use any dopamine receptor agonists other than bromocriptine and cabergoline;
5. Patients taking the other prolactinomas simultaneously;
6. pregnant or lactating women, or women preparing pregnant;
7. Patients with poor compliance, who cannot implement the program strictly.

Primary outcomes:
measure: Change from baseline on PRL level
timeFrame: Up to 2 years
Secondary outcomes:
measure: Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）
timeFrame: Up to 2 years
measure: Change from baseline of visual acuity
timeFrame: Up to 2 years
measure: Change from baseline on 5 point visual field scale
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Chongqing
country: China
facility: Xinqiao Hospital of Chongqing
state: Chongqing
city: Fuzhou
country: China
facility: First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Ruijin Hosipital
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
city: Wenzhou
country: China
facility: First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Ruijin Hospital
name: Zhebao Wu, Medical PhD
role: STUDY_CHAIR
References:
citation: Wu ZB, Yu CJ, Su ZP, Zhuge QC, Wu JS, Zheng WM. Bromocriptine treatment of invasive giant prolactinomas involving the cavernous sinus: results of a long-term follow up. J Neurosurg. 2006 Jan;104(1):54-61. doi: 10.3171/jns.2006.104.1.54.
citation: Wu ZB, Su ZP, Wu JS, Zheng WM, Zhuge QC, Zhong M. Five years follow-up of invasive prolactinomas with special reference to the control of cavernous sinus invasion. Pituitary. 2008;11(1):63-70. doi: 10.1007/s11102-007-0072-4.