Clinical trial · Interventional
Radiation Therapy in Treating Older Women Who Are Undergoing Surgery for Stage I or Stage II Breast Cancer
Radio-Surgical Treatment of Breast Cancer of Women Aged Over 70: Phase II Trial of Feasibility and Reproducibility of a Concentrated and Focalized Radiotherapy
NCT00104702CI-TRIAL-00011986GERICO03completedPhase 2ClinicalTrials.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)
RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for stage I or stage II 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Concentrated and Focalized Radiotherapy
- interventionNames
- Procedure: adjuvant therapy
- Procedure: conventional surgery
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Reproducibility
- timeFrame
- 1 month
Secondary outcomes (5)
- measure
- Impact of localized and concentrated radiotherapy on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score
- timeFrame
- 3 weeks
- measure
- Relapse-free survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of invasive breast cancer
* Stage I or II disease
* Tumor size ≤ 30 mm
* Located in any breast quadrant
* No nodal involvement
* No inflammatory breast cancer
* No positive margins after surgical resection (performed on study)
* No microcalcifications
* Hormone receptor status
* Not specified
PATIENT CHARACTERISTICS:
Age
* Over 70
Sex
* Female
Menopausal status
* Not specified
Performance status
* Karnofsky 70-100%
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specifiedReferences
Publications (0)
Data not yet available
No reference posted for this study.