Clinical trial · Interventional
Hypofractionated Radiation by CyberKnife as a Mean of the Tumor Site's Radiation After Conventional Breast Radiation.
PHASE II STUDY : Hypofractionated Radiation by CyberKnife as a Mean of Radiation of the Tumor Site After Conventional Breast Radiation.
- 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)
The CyberKnife (CK) has been developed recently. This is a linear accelerator carried by an industrial robot. It has, due to its tumor tracking capabilities and high accuracy, an interest in irradiation (boost) of tumor site after conventional irradiation. The radiation boost is currently issued by electrons, protons or brachytherapy. These techniques require several fractions and are associated with cutaneous toxicities and aesthetic problems. CK has an interest in reducing the number of fractions and a reduction of dose delivered to the skin. CK has been used in a phase I protocol (CYBERNEO) with concomitant chemotherapy for inoperable breast tumors and has proven its effectiveness and safety of treatments. The investigator is considering conducting a Phase II protocol to a single dose of 8 Grays issued by CK for boost to the tumor site after conventional breast irradiation. The results, in terms of local control, will be evaluated on clinical monitoring.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CK Boost radiation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- A - CK boost radiation
- description
- CK boost radiation
- interventionNames
- Device: CK Boost radiation
Primary outcomes (1)
- measure
- EORTC score for erythema, telangiectasia, edema, pain
- timeFrame
- 2 months
- description
- early skin toxicity evaluation by clinical examination (radiation oncology and dermatologist) using EORTC score for erythema, telangiectasia, edema, pain.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. unifocal breast cancer histologically proven 2. Age\> 18 years old, in good general condition (ECOG 0-2) 3. No cons-indication for radiotherapy 4. Patient who underwent lumpectomy and axillary dissection or sentinel node technique. 5. carcinoma histology ductal or lobular carcinoma 6. surgical margins microscopically without residual disease (\> 1 mm) 7. tumors classes T1 or T2, N0 Exclusion criteria 1. residual calcifications on X-ray examination 2. Inflammatory breast cancer, ductal (and / or in situ) and invasive lobular 3. multifocal breast Cancer 4. prior Breast radiotherapy 5. Patient who received chemotherapy
References
Publications (1)
- RESULTBondiau PY, Gal J, Chapellier C, Haudebourg J, Courdi A, Levy J, Gerard A, Sumodhee S, Maurin M, Chateau Y, Barranger E, Ferrero JM, Thariat J. Robotic Stereotactic Boost in Early Breast Cancer, a Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2019 Feb 1;103(2):374-380. doi: 10.1016/j.ijrobp.2018.09.020. Epub 2018 Oct 26. PMID 30612961