Clinical trial · Interventional
3-Dimensional Conformal Radiation Therapy or Internal Radiation Therapy After Breast-Conserving Surgery in Treating Women With Stage I or Stage II Breast Cancer
Phase II Randomised Clinical Trial of Accelerated Partial Breast Irradiation (APBI) Comparing 3-Dimensional Conformal Radiation Therapy and Multi-Catheter Interstitial Brachytherapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
RATIONALE: Specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether 3-dimensional conformal radiation therapy is more effective than internal radiation therapy when given after surgery in treating early-stage breast cancer. PURPOSE: This randomized phase II trial is studying 3-dimensional conformal radiation therapy to see how well it works compared with internal radiation therapy when given after breast-conserving surgery in treating women with 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Radiation: 3-dimensional conformal radiation therapy
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo APBI using multi-catheter interstitial brachytherapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Radiation: brachytherapy
Primary outcomes (1)
- measure
- Rate of successfully delivered accelerated partial breast irradiation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Pathologically proven invasive ductal carcinoma of the breast
* Stage I or II disease (pathological tumor size ≤ 3 cm, N0, M0 disease)
* No T2 (tumor size \> 3 cm) or T3 disease
* No lymph node (L0) or hemangiosis (V0) invasion
* Unilateral, unifocal, and unicentric tumor without associated suspicious diffuse microcalcification in the ipsilateral or contralateral breast
* No multifocal/multicentric disease
* Previously treated with breast-conserving surgery with adequate axillary node management
* Negative surgical resection margins for tumor (invasive tumor or ductal carcinoma in situ \[DCIS\]) on histology
* Clearly identified primary tumor excision cavity (clips recommended) with a target lumpectomy cavity/whole breast ratio quantifiable and ≤ 25% on the post-operative CT scan
* Patients with a lumpectomy cavity/whole breast ratio 25-30% are eligible but will undergo partial breast irradiation using multi-catheter interstitial brachytherapy during study
* Breast size amenable to partial breast irradiation (i.e., \> A-cup size)
* No other pathological invasive tumor or DCIS
* No associated extensive DCIS component (\< 25%)
* No associated Paget's disease of the nipple
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No breast implants
* No collagen vascular disease
* No psychiatric condition or other condition that, in the opinion of the investigator, would preclude study requirements
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior radiotherapy
* No concurrent chemotherapy
* Sequential chemotherapy allowed
* Concurrent hormonal therapy allowedReferences
Publications (0)
Data not yet available