Late Effects of Radiosurgery on Acromegaly Study

Brief Title

Late Effects of Radiosurgery on Acromegaly Study

Official Title

LateR-Ac Study: Late Effects of Radiosurgery on Acromegaly Study

Brief Summary

      Transsphenoidal surgery is the first-line treatment of acromegaly. Adjunctive radiotherapy
      can be necessary when surgery is ineffective to avoid a prolonged medical treatment. Several
      studies reported long-term extra-pituitary side-effects of conventional radiotherapy.
      However, none has evaluated potential side-effects induced by Gamma Knife radiosurgery, a
      highly precise stereotactic technique, that has been used as an effective treatment of
      acromegaly.

      Aims of the study: To determine potential long-term (superior to 10 years) extra-pituitary
      side-effects of Gamma Knife radiosurgery in patients treated for Acromegaly.

      Methods: Transversal exposed/unexposed study. Exposed patients have been treated by Gamma
      Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion, whereas unexposed
      patients have been treated by somatostatin analogs after unsuccessful surgery for at least 10
      years before inclusion. 80 Patients (40 patients/group) will be evaluated in terms of
      cognitive dysfunction, quality of life, secondary tumor, stroke, pituitary deficits and
      growth hormone control of hypersecretion. Recruitment is planned to last for 2 years.

      Expected results: We should be able to determine whether Gamma Knife radiosurgery is a
      long-term safe technique. This result might modify the management and follow-up of patients
      with acromegaly unsuccessfully treated by surgery.
    

Study Type

Interventional

Primary Outcome

The cognitive assessment measure a subject as cognitively preserved or cognitively impaired

Condition

Acromegaly

Intervention

Gamma Knife radiosurgery

Study Arms / Comparison Groups

 Exposed patients

Description:  Exposed patients have been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

80

Start Date

December 2014

Completion Date

December 2017

Primary Completion Date

December 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Subject, man or woman, whose age is greater than or equal to 18 years;

          -  Subject has a combination of defined values plus Insulin Like Growth Factor-1 and no
             braking growth hormone (<1.2 milli-International unit/L) during an oral glucose
             tolerance acromegaly.

          -  Exposed: Subject with a surgically treated in remission with or without drug treatment
             somatostatinergic, acromegaly who received treatment with Gamma Knife radiosurgery
             within not less than 10 years and less than or equal to 20 years.

          -  Not exposed: Subject with a surgically treated acromegaly controlled by treatment
             somatostatinergic, not having received Gamma Knife radiosurgery.

          -  Subjects with thyroid under standardized assessment Levothyrox® inclusion in case of
             deficit associated thyroid stimulating;

          -  Topic supported in a project partner services;

          -  Subjects who have signed a written informed consent and agreeing to abide by the
             instructions of the protocol.

        Exclusion Criteria:

          -  Minor or over the age of 75 years subject,

          -  Subjects with acromegaly resistant to somatostatinergic, or that required power is
             pegvisomant or cabergoline

          -  Subjects who received two pituitary neurosurgical treatment or treatment with
             conventional radiotherapy or radiosurgery treatments 2

          -  Pregnant or lactating woman,

          -  Topic is not affiliated with the social security system, or private about freedom;

          -  Subject refusing to participate in the study or not signing the informed consent;

          -  Subject with malignant disease known evolutionary
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Urielle DESALBRES, Director, 04.91.38.65.97, [email protected]

Location Countries

France

Location Countries

France

NCT ID

NCT02296216

Organization ID

2014-08

Secondary IDs

RCAPHM14_0079

Responsible Party

Sponsor

Study Sponsor

Assistance Publique Hopitaux De Marseille

Study Sponsor

Urielle DESALBRES, Director, Study Director, Assistance Publique Hôpitaux de Marseille

Verification Date

November 2014