Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed

Breast Cancer Clinical Trial

Official title:

PHASE III RANDOMISED TRIAL INVESTIGATING THE ROLE OF INTERNAL MAMMARY AND MEDIAL SUPRACLAVICULAR (IM-MS) LYMPH NODE CHAIN IRRADIATION IN STAGE I-III BREAST CANCER

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002851
• Other study ID #: CDR0000065094
• Secondary ID: EORTC-10925EORTC
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: January 28, 2010
• Start date: July 1996

Study information

• Verified date: December 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no further therapy in treating women with stage I, stage II, or stage III breast cancer that has been surgically removed.

Description:

OBJECTIVES:

• Compare the effect of irradiation of the homolateral internal mammary and medial supraclavicular lymph node chains vs no further therapy on survival, disease-free survival, metastasis-free survival, and cause of death in women with resected stage I/II/III breast cancer.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution, tumor location, type of prior breast surgery, pathologic T and N stage, menopausal status, and time sequence of radiotherapy and adjuvant chemotherapy. Patients are randomized to 1 of 2 arms.

• Arm I: Patients receive no nodal irradiation.

• Arm II: Patients receive irradiation of the internal mammary and medial supraclavicular lymph node chains delivered at 1 fraction per day, 5 sessions per week, for a total of 25 fractions over 5 weeks. Radiotherapy must begin no later than 8 weeks after surgery. If adjuvant chemotherapy is given, radiotherapy begins within 6 weeks after the last course of chemotherapy and within 8 months after surgery.

Patients are followed at least yearly after randomization for up to 20 years.

PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study within 4 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4000
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed unilateral adenocarcinoma of the breast

• Stage I/II/III (Tx, T0-3, N0-2) disease in one of the following categories or multifocal tumors if one of the foci is in agreement with the following:

• Centrally or medially located with any lymph node status

• Central location defined as underlying the areola

• Medial location defined as at least partial involvement of upper or lower medial quadrant of breast

• Externally located with axillary node involvement

• Prior mastectomy or breast-conserving surgery and axillary dissection required

• Sentinel node procedure as axillary intervention without further axillary surgery is allowed

• No prior internal mammary chain dissection

• No upper inner lesion treated with breast-conserving surgery that precludes sparing of internal mammary lymph node chain from radiotherapy volume

• Decision at radiation oncologist's discretion

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 75 and under

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No prior cardiac disease

Other:

• No prior malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

Other:

• Concurrent enrollment in other randomized trials allowed

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• adjuvant therapy

Radiation:
• low-LET electron therapy

• low-LET photon therapy

Locations

Country	Name	City	State
Belgium	Ziekenhuis Network Antwerpen Middelheim	Antwerp
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Hopital de Jolimont	Haine Saint Paul
Belgium	Cazk Groeninghe - Campus Maria's Voorzienigheid	Kortrijk
Belgium	U.Z. Gasthuisberg	Leuven
Belgium	Algemeen Ziekenhuis Sint-Augustinus	Wilrijk
Bosnia and Herzegovina	Institute of Oncology - Clinical Center University of Sarajevo	Sarajevo
Chile	Clinica Alemana	Santiago
Chile	Instituto de Radiomedicina	Santiago
France	CHR de Besancon - Hopital Jean Minjoz	Besancon
France	Institut Bergonie	Bordeaux
France	Centre de Lutte Contre le Cancer Georges-Francois Leclerc	Dijon
France	CHU de Grenoble - Hopital de la Tronche	Grenoble
France	Service Cancerologie Polyclinique Clairval	Marseille
France	Centre Antoine Lacassagne	Nice
France	Centre Eugene Marquis	Rennes
France	Centre Hospitalier Universitaire Henri Mondor	Strasbourg
France	Centre Leon Berard	Strasbourg
France	Centre Paul Strauss	Strasbourg
France	Institut Gustave Roussy	Strasbourg
Germany	Charite - Campus Charite Mitte	Berlin
Germany	Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch	Berlin
Germany	Klinik I fuer Innere Medizin	Cologne
Germany	University of Erlangen-Nuremberg	Erlangen
Germany	Universitaetsklinikum Essen	Essen
Germany	Universitaetsklinikum Goettingen	Goettingen
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Israel	Rambam Medical Center	Haifa
Israel	Chaim Sheba Medical Center	Ramat-Gan
Italy	Ospedale Sant Anna	Como
Italy	Istituto Nazionale per la Ricerca sul Cancro	Genoa (Genova)
Netherlands	Medisch Centrum Haaglanden	's-Gravenhage (Den Haag, the Hague)
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Streekziekenhuis Gooi-Noord	Blaricum
Netherlands	Radiotherapeutisch Instituut-(Riso)	Deventer
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Academisch Ziekenhuis Groningen	Groningen
Netherlands	Radiotherapeutisch Instituut Limburg-Maastricht	Maastricht
Netherlands	Dr. Bernard Verbeeten Instituut	Tilburg
Netherlands	Academisch Ziekenhuis Utrecht	Utrecht
Poland	Medical University of Gdansk	Gdansk
Portugal	Instituto Portugues de Oncologia Centro do Porto, SA	Porto
Spain	Institut Catala D'Oncologia	Barcelona
Switzerland	Hopital Cantonal Universitaire de Geneve	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	UniversitaetsSpital	Zurich
Turkey	Istanbul University-Institute of Oncology	Istanbul
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Bosnia and Herzegovina,  Chile,  France,  Germany,  Israel,  Italy,  Netherlands,  Poland,  Portugal,  Spain,  Switzerland,  Turkey,  United Kingdom, 

References & Publications (7)

Matzinger O, Heimsoth I, Poortmans P, Collette L, Struikmans H, Van Den Bogaert W, Fourquet A, Bartelink H, Ataman F, Gulyban A, Pierart M, Van Tienhoven G; EORTC Radiation Oncology & Breast Cancer Groups. Toxicity at three years with and without irradiat — View Citation

Musat E, Poortmans P, Van den Bogaert W, Struikmans H, Fourquet A, Bartelink H, Kirkove C, Budach V, Pierart M, Collette L. Quality assurance in breast cancer: EORTC experiences in the phase III trial on irradiation of the internal mammary nodes. Eur J Ca — View Citation

Poortmans P, Kouloulias V, van Tienhoven G, Collette L, Struikmans H, Venselaar JL, Van den Bogaert W, Davis JB, Lambin P; EORTC Radiation Oncology and Breast Cancer Groups. Quality assurance in the EORTC randomized trial 22922/10925 investigating the rol — View Citation

Poortmans P, Kouloulias VE, Venselaar JL, Struikmans H, Davis JB, Huyskens D, van Tienhoven G, Hurkmans C, Mijnheer B, Van den Bogaert W. Quality assurance of EORTC trial 22922/10925 investigating the role of internal mammary--medial supraclavicular irrad — View Citation

Poortmans P, Van Den Bogaert W, Venselaar J, et al.: EORTC randomized phase III trials 22922/10925 investigating the role of internal mammary chain (IMC) irradiation in stage I-II breast cancer: a quality assurance report on the dummy run. Eur J Cancer 34

Poortmans P, Van Den Bogaert W, Venselaar J, et al.: Quality assurance in EORTC trial 22922/10925 concerning internal mammary chain (IMC) irradiation: the dummy run. Radiother Oncol 48(suppl 1): A735, s186, 1998.

Poortmans PM, Venselaar JL, Struikmans H, Hurkmans CW, Davis JB, Huyskens D, van Tienhoven G, Vlaun V, Lagendijk JJ, Mijnheer BJ, De Winter KA, Van der Hulst MH, Van den Bogaert WF. The potential impact of treatment variations on the results of radiothera — View Citation