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The goal of this prospective, single-arm, phase II, non-randomized trial is to evaluate an hypofractionation schedule with high dose simultaneous integrated tumor bed boost in early breast cancer patients.
The main question[s] it aims to answer are:
This is a prospective, single-arm, phase II, non-randomized clinical trial that will test an hypofractionated schedule with high dose simultaneous integrated tumor bed boost set on a previous dose finding study. Patients will be treated with hypofractionated RT to whole breast with a dose of 40.05 Gy in 15 fractions (2.67 Gy/die) and a concomitant tumor bed dose of 52.5 Gy (3.5 gy/die). The study population will include early breast cancer patients with younger age (< or= 50 years) and additional risk factors for local recurrence.
The primary objective of the study is to evaluate the rate of radiation-induced fibrosis at 4 years.The expected enrollment is 132 patients in 6 years. Each patient must have a minimum follow-up of 4 years.
The secondary objective is to evaluate cosmesis; other objectives are to evaluate quality of life (QoL) and the rate of local control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated arm + concomitant tumor bed boost | Experimental | Hypofractionation arm, 40 Gy in 15 fractions (2.67 Gy per fraction over 3 weeks) and a tumor bed boost to a total dose of 52.5 Gy in 15 fractions (3.5 Gy per fraction over 3 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypofractionated radiotherapy with tumor bed boost | Radiation | hypofractionated radiotherapy with concomitant/simultaneous tumor bed boost |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breast fibrosis | Rate of all grades breast fibrosis evaluated by means of Common Terminology Criteria for Adverse Events (CTCAE) v. 5 scale | baseline, each year up to 4 years after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Breast cosmesis | Rate of fair and poor cosmesis evaluated by means of European Organisation for Research and Treatment of Cancer (EORTC) Cosmetic Rating System for Breast Cancer | baseline, each year up to 4 years after radiotherapy |
| Quality of Life (QOL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edy Ippolito, Prof | Contact | +3906225418081 | e.ippolito@unicampus.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università Campus Biomedico | Recruiting | Roma | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11794170 | Background | Bartelink H, Horiot JC, Poortmans P, Struikmans H, Van den Bogaert W, Barillot I, Fourquet A, Borger J, Jager J, Hoogenraad W, Collette L, Pierart M; European Organization for Research and Treatment of Cancer Radiotherapy and Breast Cancer Groups. Recurrence rates after treatment of breast cancer with standard radiotherapy with or without additional radiation. N Engl J Med. 2001 Nov 8;345(19):1378-87. doi: 10.1056/NEJMoa010874. | |
| 9060534 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Quality of Life evaluated by means of European Organization for Research and Treatment-QOL questionnaire (EORTC QLQ-C30) |
| baseline, each year up to 4 years after radiotherapy |
| Background |
| Romestaing P, Lehingue Y, Carrie C, Coquard R, Montbarbon X, Ardiet JM, Mamelle N, Gerard JP. Role of a 10-Gy boost in the conservative treatment of early breast cancer: results of a randomized clinical trial in Lyon, France. J Clin Oncol. 1997 Mar;15(3):963-8. doi: 10.1200/JCO.1997.15.3.963. |
| 10524422 | Background | Vrieling C, Collette L, Fourquet A, Hoogenraad WJ, Horiot JC, Jager JJ, Pierart M, Poortmans PM, Struikmans H, Van der Hulst M, Van der Schueren E, Bartelink H. The influence of the boost in breast-conserving therapy on cosmetic outcome in the EORTC "boost versus no boost" trial. EORTC Radiotherapy and Breast Cancer Cooperative Groups. European Organization for Research and Treatment of Cancer. Int J Radiat Oncol Biol Phys. 1999 Oct 1;45(3):677-85. doi: 10.1016/s0360-3016(99)00211-4. |
| 15878095 | Background | Yarnold J, Ashton A, Bliss J, Homewood J, Harper C, Hanson J, Haviland J, Bentzen S, Owen R. Fractionation sensitivity and dose response of late adverse effects in the breast after radiotherapy for early breast cancer: long-term results of a randomised trial. Radiother Oncol. 2005 Apr;75(1):9-17. doi: 10.1016/j.radonc.2005.01.005. Epub 2005 Mar 16. |
| 30433824 | Background | Ippolito E, Rinaldi CG, Silipigni S, Greco C, Fiore M, Sicilia A, Trodella L, D'Angelillo RM, Ramella S. Hypofractionated radiotherapy with concomitant boost for breast cancer: a dose escalation study. Br J Radiol. 2019 Mar;92(1095):20180169. doi: 10.1259/bjr.20180169. Epub 2018 Nov 28. |
| D017437 |
| Skin and Connective Tissue Diseases |