Intensity Modulated Radiotherapy for Breast Cancer - Full Text View

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00594477

Purpose

This study delivers radiation therapy to any residual breast tissue and the chest wall plus lymph node areas around the breast. These lymph node areas are under the arm, around the collar bone, and under the sternum (breastbone).

Condition	Intervention	Phase
Breast Cancer	Radiation: IMRT	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Intensity Modulated Radiation Therapy for Breast Cancer: A Phase I Feasibility Study

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

In keeping with the feasibility nature of this study, endpoints will be observed through twelve to fourteen months following the completion of radiation therapy. The CTCAE will be used for grading toxicities. [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator The purpose of this study is to find out the effectiveness and safety of a newer standard way of delivering radiation therapy called IMRT	Radiation: IMRT external beam radiation will be delivered in 180 cGy daily fractions to a total dose of 5040 cGy.

Detailed Description:

IMRT treatment uses a computer-controlled x-ray (CT) to deliver radiation beams at several different angles and strengths to deliver precise doses to the regions at risk for recurrence of breast cancer while reducing or sparing the dose to critical structures (heart, lungs0 and nearby normal tissue.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female gender
Age ≥ 18 years
Invasive primary female breast cancer
Pathologically proven regional nodal metastasis
Status post definitive breast surgery with assessment of axillary lymph nodes

Exclusion Criteria:

Distant metastasis
Currently Pregnant
Psychiatric or addictive disorders that preclude informed consent
Time from initial diagnosis to the start of radiation therapy > one year
Estimated life expectancy judged to be < one year
Prior radiation to the ipsilateral breast or chest wall
Primary breast cancer is lymphoma or sarcoma
Patients being treated with concurrent chemotherapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594477

Contacts

Contact: Imran Zoberi, MD

(314) 362-8525

zoberi@radonc.wustl.edu

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Linda M Brockman 314-454-7986 brockmal@ccadmin.wustl.edu
Principal Investigator: Imran Zoberi, MD

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Imran Zoberi, MD

Washington University School of Medicine

More Information

Publications of Results:

Ragaz J, Jackson SM, Le N, Plenderleith IH, Spinelli JJ, Basco VE, Wilson KS, Knowling MA, Coppin CM, Paradis M, Coldman AJ, Olivotto IA. Adjuvant radiotherapy and chemotherapy in node-positive premenopausal women with breast cancer. N Engl J Med. 1997 Oct 2;337(14):956-62.

Ragaz J, Olivotto IA, Spinelli JJ, Phillips N, Jackson SM, Wilson KS, Knowling MA, Coppin CM, Weir L, Gelmon K, Le N, Durand R, Coldman AJ, Manji M. Locoregional radiation therapy in patients with high-risk breast cancer receiving adjuvant chemotherapy: 20-year results of the British Columbia randomized trial. J Natl Cancer Inst. 2005 Jan 19;97(2):116-26.

Overgaard M, Hansen PS, Overgaard J, Rose C, Andersson M, Bach F, Kjaer M, Gadeberg CC, Mouridsen HT, Jensen MB, Zedeler K. Postoperative radiotherapy in high-risk premenopausal women with breast cancer who receive adjuvant chemotherapy. Danish Breast Cancer Cooperative Group 82b Trial. N Engl J Med. 1997 Oct 2;337(14):949-55.

Overgaard M, Jensen MB, Overgaard J, Hansen PS, Rose C, Andersson M, Kamby C, Kjaer M, Gadeberg CC, Rasmussen BB, Blichert-Toft M, Mouridsen HT. Postoperative radiotherapy in high-risk postmenopausal breast-cancer patients given adjuvant tamoxifen: Danish Breast Cancer Cooperative Group DBCG 82c randomised trial. Lancet. 1999 May 15;353(9165):1641-8.

Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans E, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. Review.

Fowble B, Gray R, Gilchrist K, Goodman RL, Taylor S, Tormey DC. Identification of a subgroup of patients with breast cancer and histologically positive axillary nodes receiving adjuvant chemotherapy who may benefit from postoperative radiotherapy. J Clin Oncol. 1988 Jul;6(7):1107-17.

Truong PT, Woodward WA, Buchholz TA. Optimizing locoregional control and survival for women with breast cancer: a review of current developments in postmastectomy radiotherapy. Expert Rev Anticancer Ther. 2006 Feb;6(2):205-16. Review.

Huang EH, Strom EA, Perkins GH, Oh JL, Chen AM, Meric-Bernstam F, Hunt KK, Sahin AA, Hortobagyi GN, Buchholz TA. Comparison of risk of local-regional recurrence after mastectomy or breast conservation therapy for patients treated with neoadjuvant chemotherapy and radiation stratified according to a prognostic index score. Int J Radiat Oncol Biol Phys. 2006 Oct 1;66(2):352-7. Epub 2006 Aug 2.

Huang EH, Tucker SL, Strom EA, McNeese MD, Kuerer HM, Hortobagyi GN, Buzdar AU, Valero V, Perkins GH, Schechter NR, Hunt KK, Sahin AA, Buchholz TA. Predictors of locoregional recurrence in patients with locally advanced breast cancer treated with neoadjuvant chemotherapy, mastectomy, and radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):351-7.

Pierce LJ, Butler JB, Martel MK, et al. Postmastectomy radiotherapy of the chest wall: dosimetric comparison of common techniques. Int J Radiat Oncol Biol Phys 2002;52:1220-1230.

Shapiro CL, Recht A. Side effects of adjuvant treatment of breast cancer. N Engl J Med. 2001 Jun 28;344(26):1997-2008. Review. No abstract available.

[No authors listed] Favourable and unfavourable effects on long-term survival of radiotherapy for early breast cancer: an overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet. 2000 May 20;355(9217):1757-70.

Paszat LF, Mackillop WJ, Groome PA, Boyd C, Schulze K, Holowaty E. Mortality from myocardial infarction after adjuvant radiotherapy for breast cancer in the surveillance, epidemiology, and end-results cancer registries. J Clin Oncol. 1998 Aug;16(8):2625-31. Erratum in: J Clin Oncol 1999 Feb;17(2):740.

Højris I, Overgaard M, Christensen JJ, Overgaard J. Morbidity and mortality of ischaemic heart disease in high-risk breast-cancer patients after adjuvant postmastectomy systemic treatment with or without radiotherapy: analysis of DBCG 82b and 82c randomised trials. Radiotherapy Committee of the Danish Breast Cancer Cooperative Group. Lancet. 1999 Oct 23;354(9188):1425-30.

Emami B, Lyman J, Brown A, et al. Tolerance of normal tissue to therapeutic irradiation. Int J Radiat Oncol Biol Phys 1991;21:109-122.

Marks LB, Yu X, Prosnitz RG, et al. The incidence and functional consequences of RT-associated cardiac perfusion defects. Int J Radiat Oncol Biol Phys 2005;63:214-223.

Pierce SM, Recht A, Lingos TI, Abner A, Vicini F, Silver B, Herzog A, Harris JR. Long-term radiation complications following conservative surgery (CS) and radiation therapy (RT) in patients with early stage breast cancer. Int J Radiat Oncol Biol Phys. 1992;23(5):915-23.

Bradley J, Graham MV, Winter K, Purdy JA, Komaki R, Roa WH, Ryu JK, Bosch W, Emami B. Toxicity and outcome results of RTOG 9311: a phase I-II dose-escalation study using three-dimensional conformal radiotherapy in patients with inoperable non-small-cell lung carcinoma. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):318-28.

Pierce LJ. The use of radiotherapy after mastectomy: a review of the literature. J Clin Oncol. 2005 Mar 10;23(8):1706-17. Review. No abstract available.

Campone M, Fumoleau P, Bourbouloux E, Kerbrat P, Roche H. Taxanes in adjuvant breast cancer setting: which standard in Europe? Crit Rev Oncol Hematol. 2005 Sep;55(3):167-75. Review.

Giordano SH, Duan Z, Kuo YF, Hortobagyi GN, Freeman J, Goodwin JS. Impact of a scientific presentation on community treatment patterns for primary breast cancer. J Natl Cancer Inst. 2006 Mar 15;98(6):382-8.

Taghian AG, Assaad SI, Niemierko A, Kuter I, Younger J, Schoenthaler R, Roche M, Powell SN. Risk of pneumonitis in breast cancer patients treated with radiation therapy and combination chemotherapy with paclitaxel. J Natl Cancer Inst. 2001 Dec 5;93(23):1806-11.

Burstein HJ, Bellon JR, Galper S, Lu HM, Kuter I, Taghian AG, Wong J, Gelman R, Bunnell CA, Parker LM, Garber JE, Winer EP, Harris JR, Powell SN. Prospective evaluation of concurrent paclitaxel and radiation therapy after adjuvant doxorubicin and cyclophosphamide chemotherapy for Stage II or III breast cancer. Int J Radiat Oncol Biol Phys. 2006 Feb 1;64(2):496-504. Epub 2005 Oct 21.

Yu TK, Whitman GJ, Thames HD, Buzdar AU, Strom EA, Perkins GH, Schechter NR, McNeese MD, Kau SW, Thomas ES, Hortobagyi GN, Buchholz TA. Clinically relevant pneumonitis after sequential paclitaxel-based chemotherapy and radiotherapy in breast cancer patients. J Natl Cancer Inst. 2004 Nov 17;96(22):1676-81.

Lind PA, Marks LB, Hardenbergh PH, et al. Technical factors associated with radiation pneumonitis after local +/- regional radiation therapy for breast cancer. Int J Radiat Oncol Biol Phys 2002;52:137-143

Beal K, Hudis C, Norton L, Wagman R, McCormick B. Radiation pneumonitis in breast cancer patients treated with taxanes: does sequential radiation therapy lower the risk? Breast J. 2005 Sep-Oct;11(5):317-20.

Jaen J, Vazquez G, Alonso E, et al. Changes in pulmonary function after incidental lung irradiation for breast cancer: A prospective study. Int J Radiat Oncol Biol Phys 2006;65:1381-1388.

Fan M, Marks LB, Lind P, et al. Relating radiation-induced regional lung injury to changes in pulmonary function tests. Int J Radiat Oncol Biol Phys 2001;51:311-317.

Lind PA, Marks LB, Jamieson TA, Carter DL, Vredenburgh JJ, Folz RJ, Prosnitz LR. Predictors for pneumonitis during locoregional radiotherapy in high-risk patients with breast carcinoma treated with high-dose chemotherapy and stem-cell rescue. Cancer. 2002 Jun 1;94(11):2821-9. Review.

Aitken RJ, Gaze MN, Rodger A, Chetty U, Forrest AP. Arm morbidity within a trial of mastectomy and either nodal sample with selective radiotherapy or axillary clearance. Br J Surg. 1989 Jun;76(6):568-71.

Bentzen SM, Dische S. Morbidity related to axillary irradiation in the treatment of breast cancer. Acta Oncol. 2000;39(3):337-47. Review.

Bentzen SM, Overgaard M, Thames HD. Fractionation sensitivity of a functional endpoint: impaired shoulder movement after post-mastectomy radiotherapy. Int J Radiat Oncol Biol Phys. 1989 Sep;17(3):531-7.

Fathers E, Thrush D, Huson SM, Norman A. Radiation-induced brachial plexopathy in women treated for carcinoma of the breast. Clin Rehabil. 2002 Mar;16(2):160-5.

Gerard JM, Franck N, Moussa Z, Hildebrand J. Acute ischemic brachial plexus neuropathy following radiation therapy. Neurology. 1989 Mar;39(3):450-1. No abstract available.

Gerber L, Lampert M, Wood C, Duncan M, D'Angelo T, Schain W, McDonald H, Danforth D, Findlay P, Glatstein E, et al. Comparison of pain, motion, and edema after modified radical mastectomy vs. local excision with axillary dissection and radiation. Breast Cancer Res Treat. 1992;21(2):139-45.

Lotze MT, Duncan MA, Gerber LH, Woltering EA, Rosenberg SA. Early versus delayed shoulder motion following axillary dissection: a randomized prospective study. Ann Surg. 1981 Mar;193(3):288-95.

Gillette EL, Mahler PA, Powers BE, Gillette SM, Vujaskovic Z. Late radiation injury to muscle and peripheral nerves. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1309-18. Review.

Haid A, Kuehn T, Konstantiniuk P, Köberle-Wührer R, Knauer M, Kreienberg R, Zimmermann G. Shoulder-arm morbidity following axillary dissection and sentinel node only biopsy for breast cancer. Eur J Surg Oncol. 2002 Nov;28(7):705-10.

Harper CM Jr, Thomas JE, Cascino TL, Litchy WJ. Distinction between neoplastic and radiation-induced brachial plexopathy, with emphasis on the role of EMG. Neurology. 1989 Apr;39(4):502-6.

Johansson S, Svensson H, Denekamp J. Dose response and latency for radiation-induced fibrosis, edema, and neuropathy in breast cancer patients. Int J Radiat Oncol Biol Phys. 2002 Apr 1;52(5):1207-19.

Johansson S, Svensson H, Denekamp J. Timescale of evolution of late radiation injury after postoperative radiotherapy of breast cancer patients. Int J Radiat Oncol Biol Phys. 2000 Oct 1;48(3):745-50.

Johansson S, Svensson H, Larsson LG, Denekamp J. Brachial plexopathy after postoperative radiotherapy of breast cancer patients--a long-term follow-up. Acta Oncol. 2000;39(3):373-82.

Keramopoulos A, Tsionou C, Minaretzis D, Michalas S, Aravantinos D. Arm morbidity following treatment of breast cancer with total axillary dissection: a multivariated approach. Oncology. 1993 Nov-Dec;50(6):445-9.

Olsen NK, Pfeiffer P, Mondrup K, Rose C. Radiation-induced brachial plexus neuropathy in breast cancer patients. Acta Oncol. 1990;29(7):885-90.

Ryttov N, Holm NV, Qvist N, Blichert-Toft M. Influence of adjuvant irradiation on the development of late arm lymphedema and impaired shoulder mobility after mastectomy for carcinoma of the breast. Acta Oncol. 1988;27(6A):667-70.

Stoll B, Andrews J. Radiation-induced peripheral neuropathy. British Medical Journal 1996;1:837-843.

Swedborg I, Wallgren A. The effect of pre- and postmastectomy radiotherapy on the degree of edema, shoulder-joint mobility, and gripping force. Cancer. 1981 Mar 1;47(5):877-81.

Tengrup I, Tennvall-Nittby L, Christiansson I, Laurin M. Arm morbidity after breast-conserving therapy for breast cancer. Acta Oncol. 2000;39(3):393-7.

Hack TF, Cohen L, Katz J, Robson LS, Goss P. Physical and psychological morbidity after axillary lymph node dissection for breast cancer. J Clin Oncol. 1999 Jan;17(1):143-9.

Warmuth MA, Bowen G, Prosnitz LR, Chu L, Broadwater G, Peterson B, Leight G, Winer EP. Complications of axillary lymph node dissection for carcinoma of the breast: a report based on a patient survey. Cancer. 1998 Oct 1;83(7):1362-8.

Blomqvist L, Stark B, Engler N, Malm M. Evaluation of arm and shoulder mobility and strength after modified radical mastectomy and radiotherapy. Acta Oncol. 2004;43(3):280-3.

Yamaguchi K, Ditsios K, Middleton WD, Hildebolt CF, Galatz LM, Teefey SA. The demographic and morphological features of rotator cuff disease. A comparison of asymptomatic and symptomatic shoulders. J Bone Joint Surg Am. 2006 Aug;88(8):1699-704.

Middleton WD, Teefey SA, Yamaguchi K. Sonography of the rotator cuff: analysis of interobserver variability. AJR Am J Roentgenol. 2004 Nov;183(5):1465-8.

Teefey SA, Rubin DA, Middleton WD, Hildebolt CF, Leibold RA, Yamaguchi K. Detection and quantification of rotator cuff tears. Comparison of ultrasonographic, magnetic resonance imaging, and arthroscopic findings in seventy-one consecutive cases. J Bone Joint Surg Am. 2004 Apr;86-A(4):708-16.

Kori SH, Foley KM, Posner JB. Brachial plexus lesions in patients with cancer: 100 cases. Neurology. 1981 Jan;31(1):45-50.

Mondrup K, Olsen NK, Pfeiffer P, Rose C. Clinical and electrodiagnostic findings in breast cancer patients with radiation-induced brachial plexus neuropathy. Acta Neurol Scand. 1990 Feb;81(2):153-8.

Moskovitz AH, Anderson BO, Yeung RS, Byrd DR, Lawton TJ, Moe RE. Axillary web syndrome after axillary dissection. Am J Surg. 2001 May;181(5):434-9.

Leidenius M, Leppänen E, Krogerus L, von Smitten K. Motion restriction and axillary web syndrome after sentinel node biopsy and axillary clearance in breast cancer. Am J Surg. 2003 Feb;185(2):127-30.

Maunsell E, Brisson J, Deschênes L. Arm problems and psychological distress after surgery for breast cancer. Can J Surg. 1993 Aug;36(4):315-20.

Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG) Am J Ind Med. 1996 Jun;29(6):602-8. Erratum in: Am J Ind Med 1996 Sep;30(3):372.

Hunsaker FG, Cioffi DA, Amadio PC, Wright JG, Caughlin B. The American academy of orthopaedic surgeons outcomes instruments: normative values from the general population. J Bone Joint Surg Am. 2002 Feb;84-A(2):208-15.

Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;4:11. Epub 2003 Jun 16.

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76.

Groenvold M, Klee MC, Sprangers MA, Aaronson NK. Validation of the EORTC QLQ-C30 quality of life questionnaire through combined qualitative and quantitative assessment of patient-observer agreement. J Clin Epidemiol. 1997 Apr;50(4):441-50.

McLachlan SA, Devins GM, Goodwin PJ. Validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) as a measure of psychosocial function in breast cancer patients. Eur J Cancer. 1998 Mar;34(4):510-7.

Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68.

Krueger EA, Fraass BA, McShan DL, Marsh R, Pierce LJ. Potential gains for irradiation of chest wall and regional nodes with intensity modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2003 Jul 15;56(4):1023-37.

Cho BC, Hurkmans CW, Damen EM, Zijp LJ, Mijnheer BJ. Intensity modulated versus non-intensity modulated radiotherapy in the treatment of the left breast and upper internal mammary lymph node chain: a comparative planning study. Radiother Oncol. 2002 Feb;62(2):127-36.

Welsh JS, Patel RR, Ritter MA, Harari PM, Mackie TR, Mehta MP. Helical tomotherapy: an innovative technology and approach to radiation therapy. Technol Cancer Res Treat. 2002 Aug;1(4):311-6. Review.

Ruchala KJ, Olivera GH, Kapatoes JM, Schloesser EA, Reckwerdt PJ, Mackie TR. Megavoltage CT image reconstruction during tomotherapy treatments. Phys Med Biol. 2000 Dec;45(12):3545-62.

Ding GX, Duggan DM, Coffey CW. Characteristics of kilovoltage x-ray beams used for cone-beam computed tomography in radiation therapy. Phys Med Biol. 2007 Mar 21;52(6):1595-615. Epub 2007 Feb 27.

Huntzinger C, Munro P, Johnson S, Miettinen M, Zankowski C, Ahlstrom G, Glettig R, Filliberti R, Kaissl W, Kamber M, Amstutz M, Bouchet L, Klebanov D, Mostafavi H, Stark R. Dynamic targeting image-guided radiotherapy. Med Dosim. 2006 Summer;31(2):113-25. Review.

Other Publications:

El Moussaoui R, Opmeer BC, Bossuyt PM, Speelman P, de Borgie CA, Prins JM. Development and validation of a short questionnaire in community acquired pneumonia. Thorax. 2004 Jul;59(7):591-5.

Responsible Party:	Washington University School of Medicine ( Imran Zoberi, MD )
Study ID Numbers:	07-1077
Study First Received:	January 4, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00594477
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

IMRT
breast cancer with regional nodal metastasis

Study placed in the following topic categories:

Skin Diseases
Neoplasm Metastasis
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009