Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase I/II, single-arm and open-label single-centre clinical trial with the aim to test the feasibility, safety and the efficacy, in terms of complete pathological response, of preoperative ablative radiotherapy in single fraction for selected breast cancer patients.
The research plan is conceived in two sections, as follows. (i)The technical study handles the set-up, motion and dosimetric issues of the radioablation technique using CyberKnife system.
(ii)The clinical section is organized in two studies: a phase I dose escalation study to identify the maximum tolerated dose (MTD) delivering 18 Gy, 21 Gy and 24 Gy in single fraction and a phase II study to evaluate the rate of pathological complete response (pCR) when a dose level is chosen according to the results of the previous phase I study.
Study population includes patients affected by cT1-T2 (up to 2.5 cm) cN0, adenocarcinoma of the breast, diagnosed with conventional workup. Surgical tumor removal will be scheduled after 4-8 weeks after radioablation. Whole breast radiation therapy without boost will be performed after surgery.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative Radiation Treatment | Experimental | Preoperative Radiation treatment with CyberKnife |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase I | Radiation | To establish the recommended dose defined as the maximum tolerated dose (MTD)The dose-limiting toxicity (DLT) is defined as any G3-G4 event according to NCI CTCAE Version 4.03 scale. Dose escalation is designed as a 3+3 rule-based study. Dose escalation will be initiated from a baseline dose of 18 Gy and increased to reach 21 Gy and 24 Gy. The population size includes 18 patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Identify the maximum tolerated dose (MTD) | Dose escalation is designed as a 3+3 rule-based study. Acute skin/soft tissue toxicity, measured according to NCI CTCAE v. 4.03. Any Grade 3-4 toxicity related to radioablation is considered dose limiting (DLT). | time frame:2 weeks |
| Phase II: Evaluate efficacy measured in terms of pCR rate | Rate of pCR after radioablative treatment, according to Modified Residual Cancer Burden (RCB) index | time frame:8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of chronic toxicity | Chronic skin/soft tissue, bone, lung and heart toxicities incidence measured according to NCI CTCAE v. 4.03 | time frame: 6 months - 3 years |
| Cosmetic outcomes | Measured according to the 4 points scale (poor, fair, good, excellent) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Cristina Leonardi, MD | Contact | +39 02 57489037 | cristina.leonardi@ieo.it | |
| Anna Morra, MD | Contact | +39 02 57489037 | anna.morra@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Maria Cristina Leonardi | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IEO, European Institute of Oncology IRCCS | Recruiting | Milan | 20141 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37650981 | Derived | Zerella MA, Zaffaroni M, Ronci G, Dicuonzo S, Rojas DP, Morra A, Gerardi MA, Fodor C, Rondi E, Vigorito S, Penco S, Sargenti M, Baratella P, Vicini E, Morigi C, Kahler-Ribeiro-Fontana S, Galimberti VE, Gandini S, De Camilli E, Renne G, Cattani F, Veronesi P, Orecchia R, Jereczek-Fossa BA, Leonardi MC. A narrative review for radiation oncologists to implement preoperative partial breast irradiation. Radiol Med. 2023 Dec;128(12):1553-1570. doi: 10.1007/s11547-023-01706-6. Epub 2023 Aug 31. | |
| 35366825 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017321 | Clinical Trials, Phase I as Topic |
| D017322 | Clinical Trials, Phase II as Topic |
| ID | Term |
|---|---|
| D002986 | Clinical Trials as Topic |
| D000068456 | Clinical Studies as Topic |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Phase II | Radiation | The recommended dose from the phase I study is delivered, using Cyberknife in order to evaluate the efficacy measured in terms of pCR rate. The population size includes 61 patients. |
|
| time frame: 1 - 3 years |
| Post surgery complications | Reporting of any post surgery complication (rate of infection, seroma, hematoma, necrosis, delayed wound healing) | time frame: within 30 days of surgery |
| Disease free survival | establish the rate of disease free survival | time frame: 1- 3 years |
| Local relapse | establish the rate of local relapse | time frame: 1 - 3 years |
| Overall survival | establish the rate of overall survival | time frame: 3 years |
| Breast cancer specific survival | establish the rate of breast cancer specific survival | time frame: 3 years |
| Derived |
| Zerella MA, Zaffaroni M, Ronci G, Dicuonzo S, Rojas DP, Morra A, Fodor C, Rondi E, Vigorito S, Botta F, Cremonesi M, Garibaldi C, Penco S, Galimberti VE, Intra M, Gandini S, Barberis M, Renne G, Cattani F, Veronesi P, Orecchia R, Jereczek-Fossa BA, Leonardi MC. Single fraction ablative preoperative radiation treatment for early-stage breast cancer: the CRYSTAL study - a phase I/II clinical trial protocol. BMC Cancer. 2022 Apr 2;22(1):358. doi: 10.1186/s12885-022-09305-w. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |