Clinical trial · Interventional
Hypofractionated Radiation Therapy With Concomitant Boost in Treating Women After Breast Conserving Surgery
Phase II Trial of Hypofractionated Whole-breast Radiation and Concomitant Boost to the Surgical Bed After Breast Conserving Surgery
NCT03320421CI-TRIAL-00036879completedN/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)
This phase II study is to evaluate the safety of hypofractionated whole breast radiation (HFRT) with simultaneous tumor bed boost(SIB) in women with early breast cancer after breast-conserving surgery.
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 Female | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SIB group
- description
- Radiation therapy: daily 5 days per week for 3 weeks. 43.5 Gy in 15 fractions to the whole breast 49.5 Gy in 15 fractions to the tumor bed boost
- interventionNames
- Radiation: Radiation therapy
Primary outcomes (1)
- measure
- acute radiation induced dermatitis by CTCAE within 3 months
- timeFrame
- 3 months
- description
- radiation induced skin toxicity, including rash, dry skin, ulceration etc., occurring immediately after radiation.
Secondary outcomes (5)
- measure
- late radiation toxicity by CTCAE every 3 months to 1 years after 3 months of completion of radiation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * female, aged between 18-70 * pathological confirmed breast invasive carcinoma * patients after breast lumpectomy(including quadrantectomy) with axillary lymph nodes dissection or sentinel node biopsy * stage p T 1-2 N 0 * metastasis omitted by routine examinations in 1 months before enrollment * complete blood count obtained in 2 weeks prior to study entry should meet the following criteria: absolute neutrophil count \> 1.8 \*10\^9/L, hemoglobin \> 8.0g/dl, platelet \> 75 \* 10\^9/L * hepatic and renal function in 2 weeks prior to study entry should be normal * study entry within 60 days from whichever comes later: surgery or last chemotherapy * women of childbearing potential must have a negative urine or serum pregnancy test with 2 weeks of study entry * signs study specific informed consent prior to study entry Exclusion Criteria: * breast cancer with stage III/III (AJCC 7th) * occult breast cancer * in-situ breast carcinoma * bilateral breast cancer * male breast cancer * breast lymphoma or breast sarcoma * combined with Paget's disease * received preoperative treatment(including neoadjuvant chemotherapy, endocrine therapy and target therapy * positive surgical margin * axillary lymph nodes dissection or sentinel lymph node biopsy omitted * regional lymph nodes radiation needed * boost volume larger than 1/4 of the whole breast * tumor bed unable to recognize on CT * prior invasive malignant tumor history * prior radiation to thoracic * connective tissue disease, such as active systemic lupus erythematosus and scleroderma, etc. * severe, active co-morbidity, defined as follows: * unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * severe, acute bacterial or fungal infection within the last 2 weeks * chronic obstructive pulmonary disease exacerbation or other respiratory illness within 30 days * pregnant women
References
Publications (8)
- BACKGROUNDEarly Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19. PMID 22019144
- BACKGROUNDSTART Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol. 2008 Apr;9(4):331-41. doi: 10.1016/S1470-2045(08)70077-9. Epub 2008 Mar 19. PMID 18356109
- BACKGROUNDSTART Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bentzen SM, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet. 2008 Mar 29;371(9618):1098-107. doi: 10.1016/S0140-6736(08)60348-7. Epub 2008 Mar 19. PMID 18355913
- BACKGROUNDWhelan TJ, Pignol JP, Levine MN, Julian JA, MacKenzie R, Parpia S, Shelley W, Grimard L, Bowen J, Lukka H, Perera F, Fyles A, Schneider K, Gulavita S, Freeman C. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010 Feb 11;362(6):513-20. doi: 10.1056/NEJMoa0906260. PMID 20147717
- BACKGROUNDHamilton DG, Bale R, Jones C, Fitzgerald E, Khor R, Knight K, Wasiak J. Impact of tumour bed boost integration on acute and late toxicity in patients with breast cancer: A systematic review. Breast. 2016 Jun;27:126-35. doi: 10.1016/j.breast.2016.03.002. Epub 2016 Apr 22.