Clinical trial · Interventional

Hypofractionated Versus Conventional Fractionation Radiotherapy

Hypofractionated Versus Conventional Fractionation Radiation After Conservative Surgery or Mastectomy With Irradiation of Lymph Node Drainage: a Phase II Randomized Clinical Trial for the Evaluation of Acute Toxicity

NCT04015531CI-TRIAL-00039438unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This study was designed to evaluate the acute toxicity and quality of life of hypofractionated radiation versus conventional when regional node irradiation is indicated after breast-conserving surgery or mastectomy.

Conditions

Conditions (2)

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
Radiation Toxicity	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Conventional radiotherapy	Radiation	—	UNRESOLVED
Hypofractionated radiotherapy	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Conventional radiotherapy
description
50 Gy in 25 fractions to chest wall or whole breast and regional lymph regions (supraclavicular fossa with or without axilla), followed by tumor bed boost of 10 Gy in 5 fractions in case of breast conserving surgery. Total time: 5-6 weeks.
interventionNames
1. Radiation: Conventional radiotherapy
type
EXPERIMENTAL
label
Hypofractionated radiotherapy
description
40 Gy in 15 fractions (2.67 Gy each) to chest wall or whole breast and regional lymph regions (supraclavicular fossa with or without axilla). Patients undergoing breast conserving surgery will receive concomitant boost with total dose of 48 Gy in 15 fractions (3.20 Gy each) to tumor bed. Total time: 3 weeks.
interventionNames
1. Radiation: Hypofractionated radiotherapy

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Female;
* Older than 18;
* Breast cancer stage T1 - T3;
* At least 1 lymph node positive;
* Treated with mastectomy or conservative surgery;
* Negative surgical margins;
* No distant metastasis;
* No supraclavicular or internal mammary nodes metastases;
* Adjuvant systemic therapy with chemotherapy, endocrine therapy or anti-HER2 (Human - - Epidermal Growth Factor Receptor 2) treatment is accepted;
* Signed informed consent.

Exclusion Criteria:

* Positive surgical margins;
* Concomitant chemotherapy;
* Supraclavicular or internal mammary nodes metastases;
* Distant metastasis;
* Previous thoracic radiotherapy;
* Bilateral breast cancer;
* Patients with collagen diseases;
* Unable or unwilling to sign inform consent.

References

Publications (7)

BACKGROUNDWang SL, Fang H, Song YW, Wang WH, Hu C, Liu YP, Jin J, Liu XF, Yu ZH, Ren H, Li N, Lu NN, Tang Y, Tang Y, Qi SN, Sun GY, Peng R, Li S, Chen B, Yang Y, Li YX. Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):352-360. doi: 10.1016/S1470-2045(18)30813-1. Epub 2019 Jan 30. PMID 30711522
BACKGROUNDEBCTCG (Early Breast Cancer Trialists' Collaborative Group); McGale P, Taylor C, Correa C, Cutter D, Duane F, Ewertz M, Gray R, Mannu G, Peto R, Whelan T, Wang Y, Wang Z, Darby S. Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials. Lancet. 2014 Jun 21;383(9935):2127-35. doi: 10.1016/S0140-6736(14)60488-8. Epub 2014 Mar 19. PMID 24656685
BACKGROUNDDuxbury PJ, Gandhi A, Kirwan CC, Jain Y, Harvey JR. Current attitudes to breast reconstruction surgery for women at risk of post-mastectomy radiotherapy: A survey of UK breast surgeons. Breast. 2015 Aug;24(4):502-12. doi: 10.1016/j.breast.2015.05.002. Epub 2015 May 26. PMID 26021276
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
BACKGROUNDShaitelman SF, Schlembach PJ, Arzu I, Ballo M, Bloom ES, Buchholz D, Chronowski GM, Dvorak T, Grade E, Hoffman KE, Kelly P, Ludwig M, Perkins GH, Reed V, Shah S, Stauder MC, Strom EA, Tereffe W, Woodward WA, Ensor J, Baumann D, Thompson AM, Amaya D, Davis T, Guerra W, Hamblin L, Hortobagyi G, Hunt KK, Buchholz TA, Smith BD. Acute and Short-term Toxic Effects of Conventionally Fractionated vs Hypofractionated Whole-Breast Irradiation: A Randomized Clinical Trial. JAMA Oncol. 2015 Oct;1(7):931-41. doi: 10.1001/jamaoncol.2015.2666.