Clinical trial · Observational
RapidPlan Models Establishment for Node-Positive Breast Cancer Treated With Hypofractionation Using Edge/Truebeam
NCT05486936CI-TRIAL-00060092unknownClinicalTrials.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 purpose of this trial is to establish a feasible DVH estimation model of integrated IMRT plan for HF-RNI with Eclipse™ Treatment Planning System and a Varian RapidPlan™ model based on the above DVH constraints.
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 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- study arm
- description
- Eligible breast cancer patients will receive hypofractionated radiotherapy of 2.67 Gy for 16 fractions (and sequential tumor bed boost of 2.67 Gy for 4 fractions in patients with intact breast) to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) at the discrection of radition oncologists. The plans which pass the on-line verification will then be de-identified and transferred to RapidPlan configuration workspace for RNI model training and verification.All enrolled patients will be regularly followed up during and after RT. Acute and late toxicity will be documented as well as tumor control endpoints.
- interventionNames
- Radiation: hypofractionated radiation
Primary outcomes (1)
- measure
- ≥Grade 2 acute radiation-induced toxicity
- timeFrame
- 6 months
- description
- Within time from beginning of radiotherapy to 6 months after completion of radiotherapy, any acute radiation-induced toxicity will be assessed every week during radiotherapy, 4 weeks, 3 months and 6 months after the last fraction received using the (Common Terminology Criteria for Adverse Events) CTCAE 3.0 and recorded.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18-75 years old * Ipsilateral clinically diagnosed and histologically confirmed invasive breast cancer pT1-3 * ≥1 pathologically positive axillary lymph nodes * Karnofsky Performance Status scoring ≥80 * Surgery wound healed without infection * Anticipative overall survival \>5 years * Pathologically surgical margin \>2mm * ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor * Women of child-bearing potential must agree to use adequate contraception for up to 1 month before study treatment and the duration of study participation * Ability to understand and willingness to participate the research and sign the consent form Exclusion Criteria: * Axillary dissection of less than 10 lymph nodes * Pathologically positive ipsilateral supraclavicular lymph node * Pathologically or radiologically confirmed positive ipsilateral internal mammary lymph nodes * Pregnant or lactating women * Treated with breast reconstruction surgery * Severe non-neoplastic medical comorbidities * History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix * simultaneous contralateral breast cancer * Previous RT to the neck, chest and/or ipsilateral axillary region * Active collagen vascular disease * Definitive pathological or radiologic evidence of distant metastatic disease * Primary T4 tumor * Interval between radical surgery (mastectomy or breast conserving surgery) and radiotherapy was more than 12 weeks or interval between last dose of adjuvant chemotherapy and radiotherapy was more than 8 weeks
References
Publications (0)
Data not yet available
No reference posted for this study.