Clinical trial · Interventional
Hypofractionated Radiation Therapy for Patients With Breast Cancer Receiving Regional Nodal Irradiation
NCT02958774CI-TRIAL-00077796active not recruitingN/AClinicalTrials.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)
The primary objective of this study is to document lymphedema rates in patients requiring regional nodal irradiation (RNI) who receive hypofractionated radiation as compared to conventional radiation.
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 |
|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated Radiation Therapy
- description
- Daily for 4 weeks
- interventionNames
- Radiation: Hypofractionated Radiation Therapy
Primary outcomes (1)
- measure
- Lymphedema Rate
- timeFrame
- One year post end of treatment (EOT)
- description
- Defined as a 10% increase in arm circumference from pre-treatment (baseline) arm circumference measurement.
Secondary outcomes (4)
- measure
- Local Recurrence
- timeFrame
- 12 months post-EOT
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Karnofsky Performance Status 50% - 100% * Diagnosis of stage II or III node-positive breast cancer (NOTE: Stages include: T4a-cNany, T3N1, TxN2.) OR T3N0 node-negative breast cancer. * For patients with TxN1 disease, one of the following criteria must be met: Grade 3; ≤ 45 years of age at time of screening for this study; extensive Lymphovascular Space Invasion (LVSI); 3 lymph nodes positive; hormone-negative disease; positive lymph nodes after chemotherapy; or extracapsular extension * Prior surgery and chemotherapy allowed, no prior radiation to the target area (breast or chest and nodes). NOTE: Radiation should occur 3-12 weeks after last chemotherapy or surgery, whichever comes last. * Women of child-bearing potential (WOCP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Exclusion Criteria: * Diagnosis of inflammatory breast cancer * Previously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin (unless disease-free for 5 years or more) * Diagnosis of scleroderma * Diagnosis of lupus * Diagnosis of active dermatomyositis * Diagnosis of metastatic disease * Pregnant or nursing
References
Publications (0)
Data not yet available
No reference posted for this study.