Breast CancerPhase 1IMRTNCT00594477

Intensity Modulated Radiotherapy for Breast Cancer

A Phase 1 study testing IMRT in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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). Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: IMRT
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 4 Jan 2008to 8 Aug 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female gender
Age ≥ 18 years
Invasive primary female breast cancer
Pathologically proven regional nodal metastasis
Status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection.
Signed study specific consent form

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Intensity Modulated Radiation Therapy for Breast Cancer: A Phase I Feasibility Study

Read the 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, lungs) and nearby normal tissue.

Conditions: Breast Cancer
Being tested: IMRT
Keywords: IMRT, breast cancer with regional nodal metastasis
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IMRTRadiation

Study groups in NCT00594477
Study group	Role	What they receive
IMRT	Experimental	The prescribed dose for all patients will be 5040 cGy in 28 fractions. Patients will receive external beam treatment once a day, five days a week for approximately five and a half weeks. Receives: Radiation: IMRT

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the feasibility of adjuvant comprehensive radiation therapy via IMRT with daily set-up position verified using 3D verification
The study will be deemed infeasible if greater than 10% of enrolled patients have at least one of the following outcomes:
1. Patient cannot be given the treatment because her anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised for her.
2. Within 1 year of protocol registration, the patient develops radiation pneumonitis toxicity of greater than or equal to grade 3 by CTCAE scales.
3. Within 1 year of protocol registration, the patient develops any local or regional breast cancer recurrence.
4. Within 1 year of protocol registration, the patient dies from causes judged to be related to her treatment.
Measured: Within 1 year of protocol registration

Secondary outcomes (7)

Evaluate the rate and severity of both acute and late cutaneous toxicity
Measured: 6-8 months following completion of treatment and 12-14 months following completion of treatment
Evaluate the rate and severity of late subcutaneous fibrosis
Measured: 6-8 months following completion of treatment and 12-14 months following completion of treatment
Evaluate the rate of radiation pneumonitis
Measured: 6-8 weeks following completion of treatment, 3-4 months following completion of treatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
Evaluate ipsilateral upper quadrant function
For patients who receive physical therapy, objective measures of the rotator cuff, bursa, and joint space will be evaluated by diagnostic ultrasound if medically indicated.
Measured: Pretreatment and 3-4 months following completion of treatment
Evaluate patient quality of life
Measured: Pretreatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
Evaluate local-regional control rates
Measured: 12-14 months following completion of radiation therapy
Evaluate patient set-up reproducibility in breast cancer patients treated with IMRT using daily 3D position verification
Measured: 12-14 months following completion of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 20088 Aug 2016

First posted15 Jan 2008 (estimated)
Study start4 Jan 2008
Primary completion8 Aug 2016
Study completion8 Aug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (76)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00594477
Sponsor's protocol ID: 07-1077 / 201106403
Acronym: IMRT
Status last verified: Aug 2017
First submitted: 4 Jan 2008
Last updated: 10 Aug 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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. doi: 10.1136/thx.2003.015107.
PubMed 15223867
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. doi: 10.1056/NEJM199710023371402.
PubMed 9309100
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. doi: 10.1093/jnci/djh297.
PubMed 15657341
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. doi: 10.1056/NEJM199710023371401.
PubMed 9395428
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. doi: 10.1016/S0140-6736(98)09201-0.
PubMed 10335782
Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, 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. doi: 10.1016/S0140-6736(05)67887-7.
PubMed 16360786
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. doi: 10.1200/JCO.1988.6.7.1107.
PubMed 3292711
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. doi: 10.1586/14737140.6.2.205.
PubMed 16445373
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. doi: 10.1016/j.ijrobp.2006.04.046. Epub 2006 Aug 2.
PubMed 16887286
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. doi: 10.1016/j.ijrobp.2004.09.056.
PubMed 15890574
Pierce LJ, Butler JB, Martel MK, Normolle DP, Koelling T, Marsh RB, Lichter AS, Fraass BA. Postmastectomy radiotherapy of the chest wall: dosimetric comparison of common techniques. Int J Radiat Oncol Biol Phys. 2002 Apr 1;52(5):1220-30. doi: 10.1016/s0360-3016(01)02760-2.
PubMed 11955732
Shapiro CL, Recht A. Side effects of adjuvant treatment of breast cancer. N Engl J Med. 2001 Jun 28;344(26):1997-2008. doi: 10.1056/NEJM200106283442607. No abstract available.
PubMed 11430330
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.
PubMed 10832826
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. doi: 10.1200/JCO.1998.16.8.2625.
PubMed 9704712
Hojris 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. doi: 10.1016/s0140-6736(99)02245-x.
PubMed 10543669

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intensity Modulated Radiation Therapy for Breast Cancer: A Phase I Feasibility Study
ClinicalTrials.gov ID: NCT00594477
Acronym / sponsor ID: IMRT / 07-1077 / 201106403
Conditions: Breast Cancer
Keywords: IMRT, breast cancer with regional nodal metastasis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 4 Jan 2008 (actual)
Primary completion: 8 Aug 2016 (actual)
Study completion: 8 Aug 2016 (actual)
First posted: 15 Jan 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
IMRT	Experimental	Radiation: IMRTThe prescribed dose for all patients will be 5040 cGy in 28 fractions. Patients will receive external beam treatment once a day, five days a week for approximately five and a half weeks.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Female gender
Age ≥ 18 years
Invasive primary female breast cancer
Pathologically proven regional nodal metastasis
Status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IMRT	Radiation	IMRT

Primary outcome

Evaluate the feasibility of adjuvant comprehensive radiation therapy via IMRT with daily set-up position verified using 3D verification
Time frame: Within 1 year of protocol registration
The study will be deemed infeasible if greater than 10% of enrolled patients have at least one of the following outcomes: 1. Patient cannot be given the treatment because her anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised for her. 2. Within 1 year of protocol registration, the patient develops radiation pneumonitis toxicity of greater than or equal to grade 3 by CTCAE scales. 3. Within 1 year of protocol registration, the patient develops any local or regional breast cancer recurrence. 4. Within 1 year of protocol registration, the patient dies from causes judged to be related to her treatment.

7 secondary outcomes

Evaluate the rate and severity of both acute and late cutaneous toxicity
Time frame: 6-8 months following completion of treatment and 12-14 months following completion of treatment
Evaluate the rate and severity of late subcutaneous fibrosis
Time frame: 6-8 months following completion of treatment and 12-14 months following completion of treatment
Evaluate the rate of radiation pneumonitis
Time frame: 6-8 weeks following completion of treatment, 3-4 months following completion of treatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
Evaluate ipsilateral upper quadrant function
Time frame: Pretreatment and 3-4 months following completion of treatment
Evaluate patient quality of life
Time frame: Pretreatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
Evaluate local-regional control rates
Time frame: 12-14 months following completion of radiation therapy
Evaluate patient set-up reproducibility in breast cancer patients treated with IMRT using daily 3D position verification
Time frame: 12-14 months following completion of treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
Background: PubMed 15223867El 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. doi: 10.1136/thx.2003.015107.
Background: PubMed 9309100Ragaz 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. doi: 10.1056/NEJM199710023371402.
Background: PubMed 15657341Ragaz 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. doi: 10.1093/jnci/djh297.
Background: PubMed 9395428Overgaard 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. doi: 10.1056/NEJM199710023371401.
Background: PubMed 10335782Overgaard 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. doi: 10.1016/S0140-6736(98)09201-0.
Background: PubMed 16360786Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, 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. doi: 10.1016/S0140-6736(05)67887-7.
Background: PubMed 3292711Fowble 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. doi: 10.1200/JCO.1988.6.7.1107.
Background: PubMed 16445373Truong 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. doi: 10.1586/14737140.6.2.205.
Background: PubMed 16887286Huang 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. doi: 10.1016/j.ijrobp.2006.04.046. Epub 2006 Aug 2.
Background: PubMed 15890574Huang 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. doi: 10.1016/j.ijrobp.2004.09.056.
Background: PubMed 11955732Pierce LJ, Butler JB, Martel MK, Normolle DP, Koelling T, Marsh RB, Lichter AS, Fraass BA. Postmastectomy radiotherapy of the chest wall: dosimetric comparison of common techniques. Int J Radiat Oncol Biol Phys. 2002 Apr 1;52(5):1220-30. doi: 10.1016/s0360-3016(01)02760-2.
Background: PubMed 11430330Shapiro CL, Recht A. Side effects of adjuvant treatment of breast cancer. N Engl J Med. 2001 Jun 28;344(26):1997-2008. doi: 10.1056/NEJM200106283442607. No abstract available.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Individual participant dataSharing planned: No

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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Imran Zoberi, MD principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMRT in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the feasibility of adjuvant comprehensive radiation therapy via IMRT with daily set-up position verified using 3D verification (time frame: Within 1 year of protocol registration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00594477, which also lists 76 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.