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Clinical Trials (PDQ®)

Phase III Randomized Study of Postsurgical Radiotherapy vs No Treatment for in Situ Ductal Carcinoma of the Breast Treated by Wide Excision

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Alternate Title

Radiation Therapy Compared With No Further Treatment in Treating Patients With In Situ Ductal Breast Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedunder 70EORTC-10853
UKM-ICRF-C33

Objectives

I.  Determine what proportion of patients with in situ ductal carcinoma of the 
breast may be treated by a conservative procedure.

II.  Determine whether wide excision alone or in combination with external 
breast irradiation provides adequate treatment for in situ ductal carcinoma of 
the breast.

Entry Criteria

Disease Characteristics:


Biopsy-proven, noninvasive in situ ductal carcinoma of the breast of the
following histologies:
  Solid
  Cribriform
  Papillary
  Clinging
  Comedo

Tumors up to 3 cm in diameter (5 cm optionally) must be amenable to
conservative surgical procedure

Lumps and discrete areas of microcalcification must have been completely
excised with a 1 cm margin with pathologically confirmed negative margins

No evidence of tumor spread after staging investigations 

No axillary metastases
  Clinically enlarged axillary nodes suspected of containing tumor should be
  biopsied

  Patients undergoing axillary clearance eligible if free of axillary
  metastases

No bilateral in situ ductal carcinoma

No Paget's disease of the nipple

Patients excluded because of tumor size or incomplete excision were registered
for follow-up alone until December 1993

Hormone receptor status:
  Not specified


Prior/Concurrent Therapy:


Biologic therapy:
  Not specified

Chemotherapy:
  Not specified

Endocrine therapy:
  Not specified

Radiotherapy:
  Not specified

Surgery:
  Disease amenable to conservative surgery required


Patient Characteristics:


Age:
  Under 70

Menopausal status:
  Not specified

Performance status:
  0 or 1

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No second malignancy except:
     Adequately treated basal cell skin carcinoma
     Cone-biopsied carcinoma in situ of the cervix
  No mental or social contraindication to long-term follow-up
  No pregnant women


Expected Enrollment

100 patients/year are expected to be entered over 1.5 years until a successor 
trial is available or until up to 1,000 evaluable patients have been entered.  
As of August 1995, 879 patients have been entered; entry will continue until a 
successor trial becomes available.

Outline

This is a randomized study.  Patients are randomized following wide excision.

One group receives radiotherapy to the breast; radiotherapy must begin within 
12 weeks of surgery.  Patients with a locoregional recurrence then undergo 
total mastectomy.

The other group is observed only.  Patients who experience a locoregional 
recurrence may then undergo re-excision and, if the margins are clear, 
subsequent radiotherapy.  If the margins are not clear, total mastectomy is 
recommended.

If in either group the recurrence is histologically determined to be 
infiltrating carcinoma, the patient is treated according to the policy of the 
participating institution while follow-up continues on this study.

It is recommended that patients be followed every 3 months for 3 years, every 
6 months until the 10th postoperative year, and yearly thereafter.

Published Results

Bijker N, Meijnen P, Peterse JL, et al.: Breast-conserving treatment with or without radiotherapy in ductal carcinoma-in-situ: ten-year results of European Organisation for Research and Treatment of Cancer randomized phase III trial 10853--a study by the EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group. J Clin Oncol 24 (21): 3381-7, 2006.[PUBMED Abstract]

Bijker N, Meijnen PH, Bogaerts J, et al.: Radiotherapy in breast-conserving treatment for ductal carcinoma in situ (DCIS): ten-year results of European organization for research and treatment of cancer (EORTC) randomized trial 10853. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-7, 2005.

Bijker N, Peterse JL, Fentiman IS, et al.: Effects of patient selection on the applicability of results from a randomised clinical trial (EORTC 10853) investigating breast-conserving therapy for DCIS. Br J Cancer 87 (6): 615-20, 2002.[PUBMED Abstract]

Bijker N, Peterse JL, Duchateau L, et al.: Risk factors for recurrence and metastasis after breast-conserving therapy for ductal carcinoma-in-situ: analysis of European Organization for Research and Treatment of Cancer Trial 10853. J Clin Oncol 19 (8): 2263-71, 2001.[PUBMED Abstract]

Bijker N, Peterse JL, Duchateau L, et al.: Histological type and marker expression of the primary tumour compared with its local recurrence after breast-conserving therapy for ductal carcinoma in situ. Br J Cancer 84 (4): 539-44, 2001.[PUBMED Abstract]

Bijker N, Rutgers EJ, Peterse JL, et al.: Variations in diagnostic and therapeutic procedures in a multicentre, randomized clinical trial (EORTC 10853) investigating breast-conserving treatment for DCIS. Eur J Surg Oncol 27 (2): 135-40, 2001.[PUBMED Abstract]

Julien JP, Bijker N, Fentiman IS, et al.: Radiotherapy in breast-conserving treatment for ductal carcinoma in situ: first results of the EORTC randomised phase III trial 10853. EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group. Lancet 355 (9203): 528-33, 2000.[PUBMED Abstract]

Bijker N, Bijker JL, Peterse M, et al.: Classification of ductal carcinoma in situ of the breast in the EORTC 10853 trial: do subtypes predict risk or recurrence? Results of the central pathology reveiw of the EORTC 10853 DCIS trial. Eur J Cancer 34(suppl 5): A21, s8, 1998.

Julien J, Bijker N, Sylvester I, et al.: The role of radiotherapy in breast conserving treatment of ductal carcinoma in situ DCIS: first results of the EORTC trial 10853. Eur J Cancer 34(suppl 5): A20, s8, 1998.

Related Publications

Cutuli B: Is radiotherapy needed after adequate local excision of localized DCIS? Int J Fertil Womens Med 49 (5): 231-6, 2004 Sep-Oct.[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

Jean-Pierre Julien, MD, Protocol chair (Contact information may not be current)
Ph: 33-2-3208-2222

St. Thomas' Hospital

Ian Fentiman, MD, Protocol chair
Ph: 44-207-188-4239

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.

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