Hypofractionated Radiosurgery to Treat Residual/Recurrent Non Secreting Pituitary Adenoma (HYPOADENO)

NCT06826170 | Completed

• 1 other identifier: HYPO_ADENO
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Single session stereotactic radiosurgery (SRS) is commonly used for patients with non-functioning adenomas. However the SRS can be limited by the proximity of the tumor with the surrounding critical structures (i.e., the optic chiasm). The goal of the present prospective phase II trial is to investigate early and early delayed toxicity for cranial nerves and pituitary function after hypofractionated stereotactic radiotherapy/multisession radiosurgery (hSFRT/mSRS) in residual/ recurrent non secreting pituitary adenomas. Secondary end points are late toxicity and tumour growth local control. All the enrolled patients will undergo radiosurgical treatment with a hypofractionation schedule Following radiotherapy, follow-up will be scheduled every 6 months during the first year post-radiosurgery and then annually, with the same tests. The baseline examination and the follow-up assessment will include magnetic resonance imaging (MRI), full blood counts and blood chemistry tests, neuro-ophtalmology evaluation, physical and psychological examination that included a quality-of-life (EORTC Quol 30; BN 20) and a Hospital Anxiety and Depression Scale (HADS).

Conditions

Pituitary Neoplasms; Pituitary Adenoma

Keywords

non functioning pitutary adenoma; radiosurgery; multisession radiosurgery; hypofractionated radiosurgery

Outcome Measures

Primary Outcomes (4)

• Early and late treatment related toxicity

  \- Treatment-related toxicity based on CTCAE v4.0.

  From the treatment to 36th month post-treatment

• Impact of the treatment on visual acuity

  \- Visual acuity (VA) improvement/worsening will be defined by reading increases/decreases equal of 1 or more lines (Vdetermined by the best performance on the Snellen Chart).

  From the treatment time to the 36th month post-treatment

• Impact of the treatment on the visual field

  The visual field (VF) is a continuous quantitative variable described by the mean deviation (VFMD) value, which is a summary measure of vision average loss across the visual field. VFMD values at follow-up visits that are less negative than the baseline are considered an improvement, while more negative values are considered a worsening.

  From the treatment time to the 36th month post-treatment

• Impact of the treatment on the pituitary function

  Pituitary toxicity will be defined as a clinically relevant reduction compared to the baseline of ACTH, GH, TSH, testosterone in men, period disturbances in women, new onset of diabetes insipidus due to ADH deficiency. Hormonal changes will be defined relevant if a medical therapy change\\introduction become mandatory.

  From the treatment time to the 36th month post-treatment

Secondary Outcomes (3)

• Tumor control

  From the treatment time to the 36th month post-treatment

• Impact of the treatment on the quality of life

  From the treatment time to the 36th month post-treatment.

• Impact of the treatment on anxiety and depression

  From the treatment time to the 36th month post-treatment

Study Arms (1)

Radiosurgery

EXPERIMENTAL

Patients suffering from residual/recurrent non functioning pituitary adenoma wil undergo to hypofractionated radiosurgery

Radiation: hypofractionated radiosurgery

Interventions

hypofractionated radiosurgery RADIATION

The total dose will be 25 Gy, delivered in 5 fractions, in 5 consecutive days

Radiosurgery

Eligibility Criteria

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

You may qualify if:

• Residual or progressive non secreting pituitary adenoma;
• Age ≥ 18 years; KPS ≥ 70
• Written privacy consent;
• Ability to give informed consent;

You may not qualify if:

• Previous cranial irradiation;
• Diagnosis of secreting adenoma;
• pregnancy status;
• unable to undergo MRI or CT scans;
• unable to give informed consent.

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (1)

Fondazione IRCCS Istituto Neurologico C Besta

Milan, Milan, 20133, Italy

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Radiosurgery

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 13, 2025
• Study Start: September 14, 2020
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

IT (1)