Clinical trial · Interventional
Hypofractionated Radiosurgery to Treat Residual/Recurrent Non Secreting Pituitary Adenoma (HYPOADENO)
HYPOFRACTIONATED STEREOTACTIC RADIOTHERAPY/MULTISESSION RADIOSURGERY (HSFRT/MSRS) IN RESIDUAL/ RECURRENT NON SECRETING PITUITARY ADENOMAS AN EXPLORATORY STUDY
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
| Pituitary Neoplasms | Pituitary Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hypofractionated radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiosurgery
- description
- Patients suffering from residual/recurrent non functioning pituitary adenoma wil undergo to hypofractionated radiosurgery
- interventionNames
- Radiation: hypofractionated radiosurgery
Primary outcomes (4)
- measure
- Early and late treatment related toxicity
- timeFrame
- From the treatment to 36th month post-treatment
- description
- \- Treatment-related toxicity based on CTCAE v4.0.
- measure
- Impact of the treatment on visual acuity
- timeFrame
- From the treatment time to the 36th month post-treatment
- description
- \- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Residual or progressive non secreting pituitary adenoma; * Exclusion of other treatment approach (second surgery, wait and scan; suppressive therapy) by a multidisciplinary team * Age ≥ 18 years; KPS ≥ 70 * Written privacy consent; * Ability to give informed consent; Exclusion Criteria: * Previous cranial irradiation; * Diagnosis of secreting adenoma; * pregnancy status; * unable to undergo MRI or CT scans; * unable to give informed consent.
References
Publications (0)
Data not yet available