Clinical trial · Interventional
Prospective Trial of Two Prone Breast Radiotherapy Techniques With Randomization to Concurrent Versus Weekly Boost
- 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)
1. To test the hypothesis that when prone, patients treated with 3D-CRT breast radiotherapy and randomly assigned to either a weekly or a daily boost to the tumor bed develop acute toxicity that is not significantly worse than that of a concurrent cohort of patients treated with IMRT randomly assigned to a weekly or daily boost regimen. 2. To test the hypothesis that when prone, patients treated with 3D-CRT breast radiotherapy, randomly assigned to either a weekly or a daily boost to the tumor bed develop late toxicity that is not significantly worse than that of concurrent cohort of patients treated with IMRT randomly assigned to a weekly of daily boost. 3. To test hypothesis that 5 year local control rates of ≤ 5% in-breast recurrence can be achieved in each of the two randomized arms, for either technique tested.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm 1 Daily Boost of Radiation Therapy | Radiation | — | UNRESOLVED |
| Arm 2 Weekly Boost of Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 Daily Boost of Radiation Therapy
- description
- Arm 1 of treatment, you will be receiving 15 daily radiation fractions of 2.7 Gy (measure of radiation dose) daily for three weeks to the entire breast with a daily concomitant boost of 0.5 Gy
- interventionNames
- Radiation: Arm 1 Daily Boost of Radiation Therapy
- type
- EXPERIMENTAL
- label
- Arm 2 Weekly Boost of Radiation Therapy
- description
- Arm 2 Weekly Boost will receive 15 daily radiation fractions of 2.7 Gy for three weeks to the entire breast with a weekly boost of 2.0 GY.
- interventionNames
- Radiation: Arm 2 Weekly Boost of Radiation Therapy
Primary outcomes (3)
- measure
- Number of patients with acute radiation toxicity of Grade 2 or higher.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pre- or post-menopausal women with Stage 0, I and II breast cancer (Post-menopausal women defined as either (a) at least 2 years without menstrual period or (b) or patients older than 50 with serological evidence of post-menopausal status or (c) hysterectomized patients of any age with FSH confirmation of post-menopausal status) 2. Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm 3. Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (DCIS and Tumors \<5 mm in size do not require nodal assessment) 4. At least 2 weeks from last chemotherapy 5. Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document Exclusion Criteria: 1. Previous radiation therapy to the ipsilateral breast 2. More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation 3. Active connective tissue disorders, such as lupus or scleroderma 4. Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free \> 3 years 5. Pregnant or lactating women
References
Publications (0)
Data not yet available