Clinical trial · Interventional
Radiation Dose Intensity Study in Breast Cancer in Young Women
Radiation Dose Intensity Study in Breast Cancer in Young Women: a Randomized Phase III Trial of Additional Dose to the Tumor Bed
NCT00212121CI-TRIAL-00056074unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis.
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 |
|---|---|---|---|
| boost | Procedure | — | UNRESOLVED |
| high dose boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- low dose boost (16 Gy)
- interventionNames
- Radiation: high dose boost
- Procedure: boost
- type
- EXPERIMENTAL
- label
- 2
- description
- high boost (26 Gy)
- interventionNames
- Radiation: high dose boost
- Procedure: boost
Primary outcomes (1)
- measure
- Local control at 10 yr
- timeFrame
- at every follow up visit (< 2 months after last radiation treatment and thereafter yearly
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion criteria: * Age 50 years or younger. * Histological diagnosis of invasive mammary cancer including all subtypes of invasive adenocarcinoma. * Tumor location and extension imaged prior to surgery using at least mammography and ultrasound. * Unicentric tumors and multifocal tumors removed using a wide local excision; microscopic radical resection (focally involved margins allowed, defined as: any DCIS or invasive carcinoma in 3 or fewer low-power fields (using a x 4 objective and a x 10 ocular lens, which has a diameter of 5 mm per low-power microscopic fields). * Sentinel lymph node biopsy and/or axillary lymph node dissection has been performed. * Breast cancer stage: pT1-2pN0-2a M0. * No treatment is allowed prior to surgery (no neoadjuvant chemotherapy, no neoadjuvant hormonal therapy, no pre-operative radiotherapy). * In cases where no adjuvant chemotherapy is given, wide local excision has been performed \< 10 weeks before the start of radiotherapy. * In cases where adjuvant chemotherapy is given immediately after surgery, wide local excision has been performed \< 6 months before the start of radiotherapy, and chemotherapy should be completed \< 6 weeks before the start of radiotherapy. * In cases where hormonal treatment is planned, this is given after completion of the radiotherapy. * No previous history or synchronous malignant tumor in the other breast, previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin. * ECOG performance scale 2 or less. Exclusion criteria: * Residual microcalcifications on mammogram. * All histological types of malignancies other than invasive adenocarcinoma. * In situ carcinoma of the breast, without invasive tumor. * Concurrent pregnancy. * Multicentric tumors, and multifocal. tumors excised using multiple excisions \* Invasive breast cancer in both breasts.
References
Publications (0)
Data not yet available
No reference posted for this study.