Dopamine Agonists Withdrawal Study of Invasive Prolactinomas Involving the Cavernous Sinus

Invasive Prolactinomas Involving the Cavernous Sinus Clinical Trial

Official title:

Dopamine Agonists Withdrawal Study of Invasive Prolactinomas Involving the Cavernous Sinus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02536261
• Other study ID #: WSIP-1586
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2015
• Last updated: May 15, 2017
• Start date: June 2016

Study information

• Verified date: May 2017
• Source: Ruijin Hospital
• Contact: Zhebao Wu, Medical PhD
• Phone: 21-64370045
• Email: zhebaowu[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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The purpose of this study is to observe whether dopamine agonists can be safely withdrawn after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous sinus have been effectively controlled through pharmacological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

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For giant or large invasive prolactinomas involving the cavernous sinus, whether the drug can be safely withdrawn after the tumor volume and prolactin(PRL) level have been effectively controlled through pharmacological treatment still remains unknown.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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 ?Serum prolactin level>200ng/ml, or >4000mIU/L;?enhanced Magnetic Resonance images confirm tumor invasion into cavernous sinus, i.e. Knosp grade ? or ?, 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.

Related Conditions & MeSH terms

• Invasive Prolactinomas Involving the Cavernous Sinus
• Prolactinoma

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Xinqiao Hospital of Chongqing	Chongqing	Chongqing
China	First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Huashan Hospital	Shanghai	Shanghai
China	Ruijin Hosipital	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (8)

Lead Sponsor	Collaborator
Zhebao Wu	Beijing Tiantan Hospital, First Affiliated Hospital of Fujian Medical University, First Affiliated Hospital of Wenzhou Medical Univeristy, First Hospital of China Medical University, Huashan Hospital, Peking Union Medical College Hospital, Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline on PRL level	Record the result of PRL on every 3 month follow-up visit	Up to 2 years
Secondary	Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging(MRI)	Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits	Up to 2 years
Secondary	Change from baseline of visual acuity	Record the Visual acuity on every 3 month follow-up visit	Up to 2 years
Secondary	Change from baseline on 5 point visual field scale	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	Up to 2 years