Dopamine Agonists Withdrawal Study of Invasive Prolactinomas Involving the Cavernous Sinus

NCT ID: NCT02536261

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30

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The purpose of this study is to observe whether dopamine agonists can be safely withdrawn after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous sinus have been effectively controlled through pharmacological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For giant or large invasive prolactinomas involving the cavernous sinus, whether the drug can be safely withdrawn after the tumor volume and prolactin(PRL) level have been effectively controlled through pharmacological treatment still remains unknown.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.

Conditions

Invasive Prolactinomas Involving the Cavernous Sinus

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Withdrawal group

Withdrawal observation after reaching the withdrawal standard

No interventions assigned to this group

Continue treatment group

Continue treatment obsevation after reaching the withdrawal standard

No interventions assigned to this group

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role: collaborator

First Hospital of China Medical University

OTHER

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: collaborator

Zhebao Wu

OTHER

Sponsor Role: lead

Responsible Party

Zhebao Wu

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zhebao Wu, Medical PhD

Role: STUDY_CHAIR

Ruijin Hospital

Locations

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Xinqiao Hospital of Chongqing

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status: RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Ruijin Hosipital

Shanghai, Shanghai Municipality, China

Site Status: ENROLLING_BY_INVITATION

Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhebao Wu, Medical PhD

Role: CONTACT

zhebaowu@aliyun.com

21-64370045 ext. 666091

References

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.

Reference Type: BACKGROUND

PMID: 16509147 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17917811 (View on PubMed)

Other Identifiers

WSIP-1586

Identifier Type: -

Identifier Source: org_study_id