Phase III Radiotherapy with or without Adjuvant CTX/5-FU/MTX Following Radical or Limited Surgery for Stage I/II Breast Carcinoma

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedunder 71EORTC-10801


I.  Determine the results of breast-conserving therapy (radiotherapy plus 
surgery) for operable breast cancer with regard to survival, length of 
disease-free period, and quality of life (cosmetic results, psychologic 
factors, functional tests of arm movements).

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with Stage I or II 
histologically proven breast carcinoma; axillary lymph node metastases must 
either be absent or operable.  Patients must be less than 71 years of age and 
have a Karnofsky performance index of 80 or greater.  There must not be other 
malignant tumors except nonmelanomatous skin tumors.  Patient must be 
accessible for prolonged follow-up.

Expected Enrollment

1,000 patients will be entered.


Randomized study.  Patients with histological proof of axillary node 
involvement also receive Adjuvant Therapy.
Arm I:  Surgery plus Radiotherapy.  Radical mastectomy; plus parasternal field 
and axillary field megavoltage irradiation.
Arm II:  Surgery plus Radiotherapy.  Lumpectomy; plus external megavoltage 
irradiation of the breast and booster tumor bed irradiation by Iridium 
Adjuvant Therapy:  3-Drug Combination Chemotherapy.  CMF:  Cyclophosphamide, 
CTX, NSC-26271; 5-Fluorouracil, 5-FU, NSC-19893; Methotrexate, MTX, NSC-740.

Published Results

Litière S, Werutsky G, Fentiman IS, et al.: Breast conserving therapy versus mastectomy for stage I-II breast cancer: 20 year follow-up of the EORTC 10801 phase 3 randomised trial. Lancet Oncol 13 (4): 412-9, 2012.[PUBMED Abstract]

van Dongen JA, Voogd AC, Fentiman IS, et al.: Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. J Natl Cancer Inst 92 (14): 1143-50, 2000.[PUBMED Abstract]

Curran D, van Dongen JP, Aaronson NK, et al.: Quality of life of early-stage breast cancer patients treated with radical mastectomy or breast-conserving procedures: results of EORTC Trial 10801. The European Organization for Research and Treatment of Cancer (EORTC), Breast Cancer Co-operative Group (BCCG). Eur J Cancer 34 (3): 307-14, 1998.[PUBMED Abstract]

Related Publications

Tanis E, van de Velde CJ, Bartelink H, et al.: Locoregional recurrence after breast-conserving therapy remains an independent prognostic factor even after an event free interval of 10 years in early stage breast cancer. Eur J Cancer 48 (12): 1751-6, 2012.[PUBMED Abstract]

van der Hage JA, Mieog JS, van de Velde CJ, et al.: Impact of established prognostic factors and molecular subtype in very young breast cancer patients: pooled analysis of four EORTC randomized controlled trials. Breast Cancer Res 13 (3): R68, 2011.[PUBMED Abstract]

de Bock GH, Putter H, Bonnema J, et al.: The impact of loco-regional recurrences on metastatic progression in early-stage breast cancer: a multistate model. Breast Cancer Res Treat 117 (2): 401-8, 2009.[PUBMED Abstract]

Van Nes JGH, Putter H, Bartelink H, et al.: A prognostic index for local recurrences in women with early breast cancer using European Organization for Research and Treatment of Cancer (EORTC) studies. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-2021, S86-7, 2006.

de Bock GH, van der Hage JA, Putter H, et al.: Isolated loco-regional recurrence of breast cancer is more common in young patients and following breast conserving therapy: long-term results of European Organisation for Research and Treatment of Cancer studies. Eur J Cancer 42 (3): 351-6, 2006.[PUBMED Abstract]

van Tienhoven G, Voogd AC, Peterse JL, et al.: Prognosis after treatment for loco-regional recurrence after mastectomy or breast conserving therapy in two randomised trials (EORTC 10801 and DBCG-82TM). EORTC Breast Cancer Cooperative Group and the Danish Breast Cancer Cooperative Group. Eur J Cancer 35 (1): 32-8, 1999.[PUBMED Abstract]

Wildiers J, Vantongelen K, van Dongen JA, et al.: Activities of the EORTC Breast Cancer Co-operative Group: an overview. [European Organization for Research and Treatment of Cancer] Eur J Cancer Clin Oncol 24 (1): 3-8, 1988.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Maurice J. Staquet, MD, Protocol chair
Ph: 32-2-541-3501

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.