Clinical trial · Interventional
Post-operative Radiation With IMRT in the Management of Stage IIB-III Breast Cancer
Post-operative Locoregional Irradiation Using Helical Tomotherapy IMRT in the Management of Stage IIb-III Breast Cancer: a Feasibility Study
- 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)
Research has shown that treatment with conventional radiation techniques and chemotherapy following mastectomy or breast conserving surgery has resulted in better rates of locoregional control and overall survival in stage IIB-III breast cancer. The current feasibility trial using the most recent advance in radiation therapy, namely helical tomotherapy intensity modulated radiation therapy (HT-IMRT), hopes to improve on the results of conventional radiation by decreasing the amount of radiation-induced toxicity in patients with stage IIb-III breast cancer.
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 |
|---|---|---|---|
| Helical tomotherapy IMRT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Helical tomotherapy
- description
- Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment
- interventionNames
- Procedure: Helical tomotherapy IMRT
Primary outcomes (2)
- measure
- Acute Radiation Effects (Less Than 90 Days Post Treatment)
- timeFrame
- less than 90 days post treatment
- description
- Grade 3 or higher radiation effects(less than 90 days post treatment)
- measure
- Moderate-late Pulmonary and Cardiac Radiation Effects
- timeFrame
- up to 1 year post radiation
- description
- Grade 3 or higher moderate-late pulmonary and cardiac radiation effects up to 1 year post radiation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Surgery with either mastectomy or breast conserving surgery 2. Presence and association of any of the following high risk pathological features present at time of surgery: stage pT3-4 and pN0 and central/medial location of tumour or any pT and pN2 (stage IIB-stage III) 3. All patients will have been treated previously with chemotherapy prior to radiation therapy 4. ECOG performance status of 2 or less Exclusion Criteria: 1. Prior chest wall/breast or nodal radiation for other malignancies (i.e. Hodgkin disease) 2. HER2+ positive patients 3. Patients with diagnosis of metastatic disease 4. Prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of breast cancer
References
Publications (1)
- DERIVEDCaudrelier JM, Meng J, Esche B, Grimard L, Ruddy T, Amjadi K. IMRT sparing of normal tissues in locoregional treatment of breast cancer. Radiat Oncol. 2014 Jul 22;9:161. doi: 10.1186/1748-717X-9-161. PMID 25052720