Clinical trial · Interventional
Whole Breast Irradiation With Intensity Modulated Radiotherapy and Simultaneously Integrated Boost for Early Stage Breast Cancer Patients
Phase 2 Study of Whole Breast Irradiation With Inversely Intensity Modulated Radiotherapy and Simultaneously Integrated Boost for Early Stage Breast Cancer Patients
- 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)
This is a phase II study. In patients with node-negative invasive breast cancer or carcinoma in situ treated by breast conserving surgery, postoperative whole breast irradiation with inversely intensity modulated radiotherapy and a simultaneous integrated boost is technically feasible. The aim of this study is to evaluate the radiation toxicity, cosmetic outcome and local control rate in a single center
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 |
|---|---|---|---|
| IMRT with an simultaneous integrated boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMRT-SIB
- interventionNames
- Radiation: IMRT with an simultaneous integrated boost
Primary outcomes (2)
- measure
- Radiation toxicity
- timeFrame
- first analysis will occur 2 year after accrual of all patients
- measure
- Cosmetic outcome
- timeFrame
- first analysis will occur 2 year after accrual of all patients
Secondary outcomes (4)
- measure
- Time to ipsilateral breast recurrence
- timeFrame
- first analysis will occur 5 year after accrual of all patients
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group performance score﹤2 * All patients aged \>18 years and \< 70 years after breast conserving surgery. * On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast. * Negative nodal status determined by sentinel node biopsy, or axillary dissection. Axillary staging is not required for patients with DCIS * No evidence of distant metastasis * Gross disease may be unifocal or multifocal with pathologic (invasive and/or DCIS) tumor size excised with negative margins(\>2mm) * Surgical treatment of the breast must have been lumpectomy. Re-excision of surgical margins is permitted. * The patient must consent to be in the study and must have signed an approved consent form. Exclusion Criteria: * Eastern Cooperative Oncology Group performance score≧2 * Presence of extensive intraductal component (ductal carcinoma in situ occupying \> 25% of the primary invasive tumour and present adjacent to the primary tumour).Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign. * Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant of separated. * Metastatic disease (M1) * Pregnancy or lactating * Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. * Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol. * Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma. * Prior breast or thoracic RT for any condition. * Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry. * Synchronous chemotherapy or target therapy is not permitted. * Refusal of the patients to be included in the study
References
Publications (0)
Data not yet available