Resource-sparing Post-mastectomy Radiotherapy in Breast Cancer

NCT01452672 | Unknown Phase 3 DMC

• 1 other identifier: E3.30.25
• Study Type: interventional
• Target: 600
• Locations: 8 countries
• Sites: 9

Brief Summary

This study compares two different field set-ups in patients with breast cancer following a breast resection (mastectomy). These two set-ups are as follows: arm a - radiotherapy to the chest-wall only, and arm b - radiotherapy to the chest-wall and the supraclavicular fossa. Patients in both treatment arms will receive radiotherapy with a shortened fractionation schedule. Study hypothesis: irradiation of the chest-wall only is not inferior to irradiation of the chest-wall and supraclavicular fossa in terms of loco-regional control, survival and treatment toxicity.

Conditions

Breast Cancer

Keywords

Breast cancer; Radiotherapy; Post-mastectomy; Molecular characterization

Outcome Measures

Primary Outcomes (6)

• Local control.

  The presence/absence of recurrent disease in the surgical scar, ipsilateral chest wall, ipsilateral skin and soft tissue.

  4 years

• Regional control.

  The presence/absence of recurrent disease in the axilla, ipsilateral supraclavicular/infraclavicular nodes and or ipsilateral skin/soft tissue in the regional areas.

  4 years

• Overall survival.

  4 years

• Disease-free survival.

  4 years

• Acute adverse events.

  During treatment and up to 90 days following the completion of treatment.

  4 years

• Late adverse events.

  More than 90 days after the completion of radiation therapy.

  4 years

Secondary Outcomes (4)

• Patients' demographics.

  4 years

• Reproductive history.

  1 year

• Family history.

  1 year

• Characterization of molecular profile of breast cancer patients.

  4 years

Study Arms (2)

RT to chest wall and S/C

ACTIVE COMPARATOR

Irradiation of the chest-wall and supraclavicular fossa

Radiation: Irradiation of the chest-wall and supraclavicular fossa

RT to chest wall

EXPERIMENTAL

Irradiation of the chest-wall alone

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

RT 40 Gy in 15 fractions

RT to chest wall

Irradiation of the chest-wall and supraclavicular fossa RADIATION

RT 40Gy in 15 fractions

RT to chest wall and S/C

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be older than 18 and less than 81 years of age
• WHO (ECOG) Performance Status of 0-2
• Histologically confirmed diagnosis of infiltrating ductal carcinoma of the breast, lobular carcinoma or mixed (ductal and lobular) type.
• Note: Tumor diagnosis will be performed at the participating center according to the center's routine procedures.
• Patients must have had a modified radical mastectomy (MRM) in which 6 or more axillary nodes were removed.
• All patients should receive adjuvant chemotherapy following MRM. The initiation of radiation therapy must allow for the full recovery of blood counts (WBC \> 3.0 x 109/L, Granulocytes \> 1.5 x109/L and platelets \> 75 x 109/L).
• Note: MRM should have been performed at maximum 3 months prior to the start of adjuvant chemotherapy.
• Special Note: Patients who have not received adjuvant chemotherapy will be required to receive adjuvant chemotherapy as per Appendix 3 prior to study entry and initiation of radiotherapy must allow for the full recovery of blood counts (WBC \> 3.0 x 109/L, Granulocytes \> 1.5 x109/L and platelets \> 75 x 109/L MRM should have been performed within 3 months prior to the start of adjuvant chemotherapy.
• Patients must have received adjuvant chemotherapy according to one of the two regimens found in Appendix 3.
• Negative surgical margins by histopathology at the time of MRM. Note: Negative surgical margins means that there are no cancer cells at the inked margin of resection or otherwise at the margins of the mastectomy specimen.
• The following indicators in the histological samples must be known :
• Tumor size
• Tumor site (quadrant, central, axillary tail)
• Presence of extensive intraductal component (EIC)
• Estrogen and Progesterone Receptor Status and the method of staining and detection.

You may not qualify if:

• Pathological pN3 (metastasis in 10 or more lymph nodes, clinically apparent internal mammary metastasis, metastasis in the supraclavicular lymph nodes)
• Stages IIIB, IIIC and IV (any T4, any N3 or M1)
• Recurrence of breast cancer following MRM and/or adjuvant chemotherapy.
• Concomitant primary cancer in the contralateral breast.
• History of other malignancy except carcinoma in situ of the cervix or non-melanoma skin cancer
• Pregnant or breast-feeding
• Previous chemotherapy other than adjuvant chemotherapy for treatment of the present breast cancer
• Other severe concomitant disease that could impact upon the ability to deliver treatment or increase the risk of toxicity (such as uncompensated congestive heart failure, unstable coronary heart disease, uncompensated chronic obstructive pulmonary disease, collagen vascular diseases including systemic lupus erythematosus, systemic sclerosis, dermatomyositis, and ataxia telangiectasia).
• Contraindications to radiation therapy (such as previous irradiation of the breast or chest wall)
• Severe psychiatric disorder that may interfere with the process of informed consent and/or treatment or follow-up compliance.

Sponsors & Collaborators

• International Atomic Energy Agency: lead
• International Network for Cancer Treatment and Research: collaborator

Study Sites (9)

Instituto Naciolal de Oncologia y Radiobiologia (INOR)

Havana, 10400, Cuba

RECRUITING

Cairo National Cancer Institute

Cairo, Fom El-Khalig, 11796, Egypt

RECRUITING

Alexandria Ayadi Almostakbal Oncology Cenre.

Alexandria, Egypt

RECRUITING

Korle Bu Teaching Hospital

Accra, Ghana

RECRUITING

Institut National d'Oncologie

Rabat, 10100, Morocco

RECRUITING

University of Ibadan College Hospital

Ibadan, Nigeria

RECRUITING

Institut of Radiotherapy and Nuclear Medicine (IRNUM)

Peshawar, 25120, Pakistan

RECRUITING

Instituto Nacional de Enfermedades Neoplasicas

Lima, 34, Peru

RECRUITING

Cerraphasa Medical Faculty

Istanbul, 34303, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Nielsen HM, Overgaard M, Grau C, Jensen AR, Overgaard J. Loco-regional recurrence after mastectomy in high-risk breast cancer--risk and prognosis. An analysis of patients from the DBCG 82 b&c randomization trials. Radiother Oncol. 2006 May;79(2):147-55. doi: 10.1016/j.radonc.2006.04.006. Epub 2006 Apr 27.

  PMID: 16647152 BACKGROUND

• Adenipekun A, Campbell OB, Oyesegun AR, Elumelu TN. Radiotherapy in the management of early breast cancer in Ibadan: outcome of chest wall irradiation alone in clinically nodes free axilla. Afr J Med Med Sci. 2002 Dec;31(4):345-7.

  PMID: 15027777 BACKGROUND

• Truong PT, Olivotto IA, Whelan TJ, Levine M; Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. Clinical practice guidelines for the care and treatment of breast cancer: 16. Locoregional post-mastectomy radiotherapy. CMAJ. 2004 Apr 13;170(8):1263-73. doi: 10.1503/cmaj.1031000.

  PMID: 15078851 BACKGROUND

• Owen JR, Ashton A, Bliss JM, Homewood J, Harper C, Hanson J, Haviland J, Bentzen SM, Yarnold JR. Effect of radiotherapy fraction size on tumour control in patients with early-stage breast cancer after local tumour excision: long-term results of a randomised trial. Lancet Oncol. 2006 Jun;7(6):467-71. doi: 10.1016/S1470-2045(06)70699-4.

  PMID: 16750496 BACKGROUND

• Whelan T, MacKenzie R, Julian J, Levine M, Shelley W, Grimard L, Lada B, Lukka H, Perera F, Fyles A, Laukkanen E, Gulavita S, Benk V, Szechtman B. Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. J Natl Cancer Inst. 2002 Aug 7;94(15):1143-50. doi: 10.1093/jnci/94.15.1143.

  PMID: 12165639 BACKGROUND

Related Links

• International Atomic Energy Agency

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Eduardo Rosenblatt, MD

  International Atomic Energy Agency

  STUDY CHAIR

Central Study Contacts

Eduardo Rosenblatt, MD

CONTACT

(43 1) 2600-21669; e.rosenblatt@iaea.org

Eeva K. Salminen, Section Head

CONTACT

(43 1) 2600-26511; e.salminen@iaea.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 17, 2011
• Study Start: March 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 17, 2011

Record last verified: 2011-10

Locations

GH (1); CU (1); NG (1); MO (1); EG (2); TU (1); PA (1); PE (1)