Resource-sparing Post-mastectomy Radiotherapy in Breast Cancer
Recruitment status was Recruiting
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.
Radiation: Irradiation of the chest-wall and supraclavicular fossa
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Resource-sparing Radiotherapy for Breast Cancer|
- Local control. [ Time Frame: 4 years ] [ Designated as safety issue: No ]The presence/absence of recurrent disease in the surgical scar, ipsilateral chest wall, ipsilateral skin and soft tissue.
- Regional control. [ Time Frame: 4 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Disease-free survival. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Acute adverse events. [ Time Frame: 4 years ] [ Designated as safety issue: No ]During treatment and up to 90 days following the completion of treatment.
- Late adverse events. [ Time Frame: 4 years ] [ Designated as safety issue: No ]More than 90 days after the completion of radiation therapy.
- Patients' demographics. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Reproductive history. [ Time Frame: 1 year ] [ Designated as safety issue: No ]Number of pregnancies, miscarriages. Menstrual History.
- Family history. [ Time Frame: 1 year ] [ Designated as safety issue: No ]Family history of breast cancer.
- Characterization of molecular profile of breast cancer patients. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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
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.
|Contact: Eduardo Rosenblatt, MD||(43 1) 2600-21669 ext email@example.com|
|Contact: Eeva K. Salminen, Section Head||(43 1) 2600-26511 ext firstname.lastname@example.org|
|Instituto Naciolal de Oncologia y Radiobiologia (INOR)||Recruiting|
|Havana, Cuba, 10400|
|Contact: Jorge M. Marinello, MD email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Magda M. El-Mongy, MD|
|Alexandria Ayadi Almostakbal Oncology Cenre.||Recruiting|
|Contact: Ahmed Elzawawy, MD +20-66-33-32-758 email@example.com|
|Principal Investigator: Ahmed Elsawawy, MD|
|Korle Bu Teaching Hospital||Recruiting|
|Contact: Verna Vanderpuye, MD +233-21-676222/669202 firstname.lastname@example.org|
|Principal Investigator: Verna Vanderpuye, MD|
|Institut National d'Oncologie||Recruiting|
|Rabat, Morocco, 10100|
|Contact: Mansouri Aziz, MD email@example.com|
|Principal Investigator: Mansouri Aziz, MD|
|University of Ibadan College Hospital||Recruiting|
|Contact: Oladapo B. Campbell, MD +234-803 firstname.lastname@example.org|
|Principal Investigator: Oladapo B. Campbell, MD|
|Institut of Radiotherapy and Nuclear Medicine (IRNUM)||Recruiting|
|Peshawar, Pakistan, 25120|
|Contact: Safoora Shahid, MD 0092-91-9216114 email@example.com|
|Principal Investigator: Safoora Shahid, MD|
|Instituto Nacional de Enfermedades Neoplasicas||Recruiting|
|Lima, Peru, 34|
|Contact: Jorge A. Moscol_Ledesma, MD +51-1-4499137 firstname.lastname@example.org|
|Principal Investigator: Jorge A. Moscol-Ledesma, MD|
|Cerraphasa Medical Faculty||Recruiting|
|Istanbul, Turkey, 34303|
|Contact: Nuran Bese, MD +90-532-4680805 email@example.com|
|Principal Investigator: Nuran Bese, MD|
|Study Chair:||Eduardo Rosenblatt, MD||International Atomic Energy Agency|