Clinical trial · Observational
Efficacy of Preoperative Radiotherapy for Non-responder Patients After Neoadjuvant Chemotherapy
Efficacy of Preoperative Radiotherapy for Non-responder Patients After Neoadjuvant Chemotherapy: a Pilot Observational Study
- 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)
Neoadjuvant chemotherapy (NACT) is widely used for locally advanced breast cancer cases. As the key factor is to achieve pathologic complete response (pCR), several physicians tried administering radiotherapy before surgery to increase response rates. In this single center observational cohort study, we aim to present the initial results as complete response rates and complication rates of additional neoadjuvant radiotherapy (NART) after NACT.
Conditions
Conditions (4)
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 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Radiotherapy; Complications | — | UNRESOLVED | — |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Complete response rate following neoadjuvant radiotherapy
- timeFrame
- Up to 4 weeks after definitive surgery
- description
- Additional complete response effect of neoadjuvant radiotherapy for non-clinical complete responder patients following neoadjuvant chemotherapy.
Secondary outcomes (1)
- measure
- Radiotherapy toxicity
- timeFrame
- During the first Four weeks after the last dose of radiotherapy
- description
- Toxicity degree of neoadjuvant radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * American Joint Committee on Cancer (AJCC) clinical T1-3 * Biopsy proven N+ * Non-metastatic (M0) * Patients who are planned to receive adjuvant radiotherapy at initial evaluation * Patients who are candidate for neoadjuvant chemotherapy * Patients who did not achieved clinical complete response after neoadjuvant chemotherapy Exclusion Criteria: * AJCC clinical T4 * AJCC Clinical N- * AJCC Clinical M1 * Patients who achieved clinical complete response after neoadjuvant chemotherapy * Patients who did not consent to have neoadjuvant radiotherapy
References
Publications (2)
- BACKGROUNDOzkurt E, Sakai T, Wong SM, Tukenmez M, Golshan M. Survival Outcomes for Patients With Clinical Complete Response After Neoadjuvant Chemotherapy: Is Omitting Surgery an Option? Ann Surg Oncol. 2019 Oct;26(10):3260-3268. doi: 10.1245/s10434-019-07534-1. Epub 2019 Jul 24. PMID 31342356
- RESULTBollet MA, Belin L, Reyal F, Campana F, Dendale R, Kirova YM, Thibault F, Dieras V, Sigal-Zafrani B, Fourquet A. Preoperative radio-chemotherapy in early breast cancer patients: long-term results of a phase II trial. Radiother Oncol. 2012 Jan;102(1):82-8. doi: 10.1016/j.radonc.2011.08.017. Epub 2011 Sep 8. PMID 21907436