Phase I/II Clinical Trial on Single Fraction Ablative Preoperative Radiation Treatment for Early Stage Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 79
- Locations
- 2
- Primary Endpoint
- Phase II: Evaluate efficacy measured in terms of pCR rate
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically proven unifocal adenocarcinoma
- •Tumor size up to 2.5 cm
- •Age ≥ 18 years old
- •Good general condition (ECOG 0-2)
- •Planned BCS
- •Written informed consent
Exclusion Criteria
- •Tumor close to skin or chest wall
- •Pure non-invasive tumor
- •Prior RT to the chest
- •Neoadjuvant chemotherapy
- •Collagenopathies
- •Coagulation or autoimmunitary disorders
- •Previous malignancies
Outcomes
Primary Outcomes
Phase II: Evaluate efficacy measured in terms of pCR rate
Time Frame: time frame:8 weeks
Rate of pCR after radioablative treatment, according to Modified Residual Cancer Burden (RCB) index
Phase I: Identify the maximum tolerated dose (MTD)
Time Frame: time frame:2 weeks
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).
Secondary Outcomes
- Cosmetic outcomes(time frame: 1 - 3 years)
- Local relapse(time frame: 1 - 3 years)
- Incidence of chronic toxicity(time frame: 6 months - 3 years)
- Disease free survival(time frame: 1- 3 years)
- Post surgery complications(time frame: within 30 days of surgery)
- Overall survival(time frame: 3 years)
- Breast cancer specific survival(time frame: 3 years)