Resource-sparing Post-mastectomy Radiotherapy in Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01452672|
Recruitment Status : Unknown
Verified October 2011 by International Atomic Energy Agency.
Recruitment status was: Recruiting
First Posted : October 17, 2011
Last Update Posted : October 17, 2011
This study compares two different field set-ups in patients with breast cancer following a breast resection (mastectomy). These two set-ups are as follows: arm a - radiotherapy to the chest-wall only, and arm b - radiotherapy to the chest-wall and the supraclavicular fossa.
Patients in both treatment arms will receive radiotherapy with a shortened fractionation schedule.
Study hypothesis: irradiation of the chest-wall only is not inferior to irradiation of the chest-wall and supraclavicular fossa in terms of loco-regional control, survival and treatment toxicity.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Radiotherapy Radiation: Irradiation of the chest-wall and supraclavicular fossa||Phase 3|
Post-mastectomy radiotherapy (PMRT) substantially reduces the risk of loco- regional failure as shown in several studies and meta-analyses. Two large trials for pre-menopausal node-positive breast cancer patients treated with mastectomy and chemotherapy showed that PMRT not only reduced loco- regional failure rates but also improved disease-free and overall survival rates.
Although the benefit of PMRT is clear, the optimal volume of tissues to be covered by the radiotherapy fields is controversial. Since the chest wall is the most likely location of recurrence, there is uniform consensus that the chest wall should be irradiated. However, areas of controversy exist regarding irradiation of the regional lymph nodes (axillary, supraclavicular and internal mammary lymph nodes), optimal radiation dose, and dose-fractionation.
If equivalent results could be achieved by omitting irradiation of the supraclavicular region in patients receiving adjuvant systemic therapy, this will simplify and expedite treatment in this patient population. Furthermore, the use of a shortened fractionation schedule of 40 Gy in 15 fractions (2.67 Gy per fraction) over 3 weeks which has been used in the UK and Canada for post-mastectomy patients for several decades will shorten the duration of treatment by reducing the number of patient visits for radiotherapy and increase the number of patients who can be treated. Treatment will be more convenient for patients and a reduction in the number of treatments could result in savings for strained health care systems.
This is a randomized comparison of two different radiotherapy field set-ups for post-mastectomy treatment of locally advanced breast cancer. Patients who have undergone modified radical mastectomy including axillary lymph node dissection will be randomized to receive one of two radiotherapy treatment arms, A and B following the completion of adjuvant chemotherapy. The radiotherapy for treatment Arm A consists of irradiation of the chest wall only while Treatment Arm B includes irradiation of the chest wall and the ipsilateral supraclavicular field. Patients on both treatment arms will receive radiation with a shortened fractionation schedule. Patients will be evaluated for local control, regional control, survival and treatment toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Resource-sparing Radiotherapy for Breast Cancer|
|Study Start Date :||March 2007|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
Active Comparator: RT to chest wall and S/C
Irradiation of the chest-wall and supraclavicular fossa
Radiation: Irradiation of the chest-wall and supraclavicular fossa
RT 40Gy in 15 fractions
Experimental: RT to chest wall
Irradiation of the chest-wall alone
RT 40 Gy in 15 fractions
- Local control. [ Time Frame: 4 years ]The presence/absence of recurrent disease in the surgical scar, ipsilateral chest wall, ipsilateral skin and soft tissue.
- Regional control. [ Time Frame: 4 years ]The presence/absence of recurrent disease in the axilla, ipsilateral supraclavicular/infraclavicular nodes and or ipsilateral skin/soft tissue in the regional areas.
- Overall survival. [ Time Frame: 4 years ]
- Disease-free survival. [ Time Frame: 4 years ]
- Acute adverse events. [ Time Frame: 4 years ]During treatment and up to 90 days following the completion of treatment.
- Late adverse events. [ Time Frame: 4 years ]More than 90 days after the completion of radiation therapy.
- Patients' demographics. [ Time Frame: 4 years ]
- Reproductive history. [ Time Frame: 1 year ]Number of pregnancies, miscarriages. Menstrual History.
- Family history. [ Time Frame: 1 year ]Family history of breast cancer.
- Characterization of molecular profile of breast cancer patients. [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452672
|Contact: Eduardo Rosenblatt, MD||(43 1) 2600-21669 ext firstname.lastname@example.org|
|Contact: Eeva K. Salminen, Section Head||(43 1) 2600-26511 ext email@example.com|
|Instituto Naciolal de Oncologia y Radiobiologia (INOR)||Recruiting|
|Havana, Cuba, 10400|
|Contact: Jorge M. Marinello, MD firstname.lastname@example.org|
|Principal Investigator: Jorge M. Marinello, MD|
|Cairo National Cancer Institute||Recruiting|
|Cairo, Fom El-Khalig, Egypt, 11796|
|Contact: Magda M. El-Mongy, MD +20-101-714805 email@example.com|
|Principal Investigator: Magda M. El-Mongy, MD|
|Alexandria Ayadi Almostakbal Oncology Cenre.||Recruiting|
|Contact: Ahmed Elzawawy, MD +20-66-33-32-758 firstname.lastname@example.org|
|Principal Investigator: Ahmed Elsawawy, MD|
|Korle Bu Teaching Hospital||Recruiting|
|Contact: Verna Vanderpuye, MD +233-21-676222/669202 email@example.com|
|Principal Investigator: Verna Vanderpuye, MD|
|Institut National d'Oncologie||Recruiting|
|Rabat, Morocco, 10100|
|Contact: Mansouri Aziz, MD firstname.lastname@example.org|
|Principal Investigator: Mansouri Aziz, MD|
|University of Ibadan College Hospital||Recruiting|
|Contact: Oladapo B. Campbell, MD +234-803 email@example.com|
|Principal Investigator: Oladapo B. Campbell, MD|
|Institut of Radiotherapy and Nuclear Medicine (IRNUM)||Recruiting|
|Peshawar, Pakistan, 25120|
|Contact: Safoora Shahid, MD 0092-91-9216114 firstname.lastname@example.org|
|Principal Investigator: Safoora Shahid, MD|
|Instituto Nacional de Enfermedades Neoplasicas||Recruiting|
|Lima, Peru, 34|
|Contact: Jorge A. Moscol_Ledesma, MD +51-1-4499137 email@example.com|
|Principal Investigator: Jorge A. Moscol-Ledesma, MD|
|Cerraphasa Medical Faculty||Recruiting|
|Istanbul, Turkey, 34303|
|Contact: Nuran Bese, MD +90-532-4680805 firstname.lastname@example.org|
|Principal Investigator: Nuran Bese, MD|
|Study Chair:||Eduardo Rosenblatt, MD||International Atomic Energy Agency|