Hypofractionated Brain Radiationcavity

Study Overview
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Brief Summary
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Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity after metastasectomy in cancer patients with brain metastases

Detailed Description
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Patients with limited number of brain metastases from solid tumors are at high risk of local recurrence after surgical removal of the tumor mass. The standard Whole-brain radiotherapy (WBRT) demonstrated to reduce the risk of recurrence without improving survival. At the same time WBRT have substantial acute and late toxicity. Preliminary experiences with Stereotactic radiosurgery or hypofractionated radiotherapy of the resection cavity indicate promising local control and good tolerance. This attitude was only partially explored in prospective trials. In this research patients with limited number of brain metastases and controlled systemic disease will be treated, with such a stereotactic irradiation, at the same time with evaluation of the local control (Primary endpoint) by repeated MRI and of quality of life, neurologic functionning (with a battery of thsts, e.g. MMSE, QLQ-C30, EORTC BN-20) as well as overall survival as secondary endpoints.

Official Title
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Stereotactic Radiosurgery or Hypofractionated Image-Guided Radiotherapy to the Surgical Cavity After Resection of Brain Metastases: a Multicenter, Single Arm, Open-label, Phase II Trial

Conditions
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Brain Metastases, Adult, Cancer Brain

Intervention / Treatment
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* Radiation: IGRT
* Radiation: SRS


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patient underwent surgery for single brain metastasis arising from solid neoplasia (lung, breast, melanoma, kidney, colorectal), with initial histological diagnosis, or selected cases with a resected lesion and a further non-resected lesion (from 1 to 2 lesions), treatable with SRS / IGRT of the surgical cavity Patient ≥ 18 years Willngness to participate in the study, written informed consent Performance Status according to WHO 0-I Good general conditions and organ function Newly diagnosed chemotherapy-naïve disease or controlled systemic disease Good bone marrow, renal and hepatic function Stable steroid dose or reduced for at least 5 days Exclusion Criteria: History of previous brain irradiation Pregnancy or breastfeeding Histological diagnosis other than lung, breast, melanoma, kidney and colorectal malignancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IGRT<br>Image-Guided Hypofractionated Stereotactic Radiation Therapy (IGRT) of the resection cavity | Radiation: IGRT<br>* Image-Guided Radiation Therapy<br>|
| Experimental: SRS<br>Stereotactic Radiosurgery of the resection cavity (SRS) | Radiation: SRS<br>* stereotactic radiation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse rate | Evaluate the recurrence probability in the surgical cavity after radiotherapy | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The proportion of surviving patients at 1 year | 1 year | 
| Time to systemic progression | The proportion of patients with progression of disease in any location other than the brain, according to CTCAE Criteria | 1 year | 
| Time to neurological progression | Time to neurological deterioration (objective neurological examination and MMSE) | 1 year | 
| Quality of life assessment | Evaluation of the quality of life through questionnaire | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radation therapy, sterotactic radiosurgery, quality of life, solid cancer, palliation, neurologic functionning