Multicenter Evaluation of the Effect of Upfront Radiosurgery on Residual Growth Hormone-secreting Pituitary Adenoma

NCT03439709 | Unknown Phase 3 DMC

• 1 other identifier: SMC 2017-11-091-002
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators hypothesize that upfront gamma knife radiosurgery with drug therapy is superior in the treatment of growth hormone-secreting pituitary tumors after primary surgical treatment compared with the drug therapy alone. This study can provide useful clinical information in the treatment of patients with acromegaly.

Conditions

Acromegaly Due to Pituitary Adenoma

Keywords

acromegaly; pituitary adenoma; gamma knife radiosurgery; adjuvant treatment

Outcome Measures

Primary Outcomes (1)

• endocrinologic remission

  Achieving random growth hormone level below 2.5 ug/L and normalization of insulin-growth factor-1 level

  at 2 year after initial enrollment

Secondary Outcomes (4)

• tumor size

  1 year interval

• drug requirement dosage

  at 3 months after initial enrollment and 6 months thereafter for 2 years

• side effect

  at 3 months after initial enrollment and 6 months thereafter for 2 years

• performance status

  at 3 months after initial enrollment and 6 months thereafter for 2 years

Study Arms (2)

intervention

EXPERIMENTAL

Gamma knife radiosurgery (Leksell Gamma Knife, Elekta AB, Stockholm, Sweden) is used for intervention. Administration of standard medical therapy using Lanreotide 60 mg concurrently starts with radiosurgery

Radiation: Gamma knife radiosurgery; Drug: Lanreotide 60Mg Solution for Injection

control

ACTIVE COMPARATOR

Without radiosurgery, standard medical therapy (Lanreotide 60Mg Solution for Injection) same with interventional group is applied

Drug: Lanreotide 60Mg Solution for Injection

Interventions

Gamma knife radiosurgery RADIATION

Minimum 25 Gy of marginal dose is applied for residual tumor or resection cavity. Depending on the size of tumor, the dose can be varied.

intervention

Lanreotide 60Mg Solution for Injection DRUG

Lanreotide injection.

control; intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Among patients with acromegaly due to growth hormone secreting pituitary adenoma who underwent primary surgical resection, patients who fail to achieve endocrinologic remission at 3 months after surgery.
• On brain MRI scan at 3months after surgery, residual tumor is confirmed by clinicians
• the definition of endocrinologic remission
• random growth hormone level \< 2.5 ug/L
• normalization of age-matched insulin growth factor-1 level

You may not qualify if:

• patients with contraindication of stereotactic radiosurgery; e.g. pregnancy or planning pregnancy, or claustrophobia
• recurrent pituitary adenoma
• limited life expectancy due to systemic disease; e.g. malignant tumor, genetic disease, and terminal stage of renal or hepatic failure
• disability to clinic visit due to postoperative complications

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (6)

• Gheorghiu ML. Updates in outcomes of stereotactic radiation therapy in acromegaly. Pituitary. 2017 Feb;20(1):154-168. doi: 10.1007/s11102-016-0783-5.

  PMID: 28210908 BACKGROUND

• Lee CC, Vance ML, Xu Z, Yen CP, Schlesinger D, Dodson B, Sheehan J. Stereotactic radiosurgery for acromegaly. J Clin Endocrinol Metab. 2014 Apr;99(4):1273-81. doi: 10.1210/jc.2013-3743. Epub 2014 Jan 28.

  PMID: 24471574 BACKGROUND

• Shin SS, Tormenti MJ, Paluzzi A, Rothfus WE, Chang YF, Zainah H, Fernandez-Miranda JC, Snyderman CH, Challinor SM, Gardner PA. Endoscopic endonasal approach for growth hormone secreting pituitary adenomas: outcomes in 53 patients using 2010 consensus criteria for remission. Pituitary. 2013 Dec;16(4):435-44. doi: 10.1007/s11102-012-0440-6.

  PMID: 23179961 BACKGROUND

• Giustina A, Chanson P, Kleinberg D, Bronstein MD, Clemmons DR, Klibanski A, van der Lely AJ, Strasburger CJ, Lamberts SW, Ho KK, Casanueva FF, Melmed S; Acromegaly Consensus Group. Expert consensus document: A consensus on the medical treatment of acromegaly. Nat Rev Endocrinol. 2014 Apr;10(4):243-8. doi: 10.1038/nrendo.2014.21. Epub 2014 Feb 25.

  PMID: 24566817 BACKGROUND

• Hazer DB, Isik S, Berker D, Guler S, Gurlek A, Yucel T, Berker M. Treatment of acromegaly by endoscopic transsphenoidal surgery: surgical experience in 214 cases and cure rates according to current consensus criteria. J Neurosurg. 2013 Dec;119(6):1467-77. doi: 10.3171/2013.8.JNS13224. Epub 2013 Sep 27.

  PMID: 24074496 BACKGROUND

• Katznelson L, Laws ER Jr, Melmed S, Molitch ME, Murad MH, Utz A, Wass JA; Endocrine Society. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014 Nov;99(11):3933-51. doi: 10.1210/jc.2014-2700. Epub 2014 Oct 30.

  PMID: 25356808 BACKGROUND

MeSH Terms

Conditions

Growth Hormone-Secreting Pituitary Adenoma; Acromegaly; Pituitary Neoplasms

Interventions

Radiosurgery; lanreotide; Solutions; Injections

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy

Study Officials

• Doo0Sik Kong, MD,Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doo-Sik Kong, MD,Ph.D

CONTACT

+82-2-3410-0732; doosik.kong@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Technically, the procedure of gamma knife radiosurgery includes fixating stereotactic frame on the head of patients. Therefore, It is not possible to keep masking for participants and other investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients with acromegaly due to growth hormone secreting pituitary adenoma who receive primary surgical resection and fail to achieve endocrinologic remission at 3 months after surgical resection are enrolled. They are devided into two groups; One consists of patients underwent upfront stereotactic radiosurgery combinated with standard drug therapy, and another group consists of patients receiving only standard drug therapy.

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 20, 2018
• Study Start: March 1, 2018
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 1, 2018

Record last verified: 2018-02

Locations

KR (1)