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Resource-sparing Post-mastectomy Radiotherapy in Breast Cancer

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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
Sponsor:
Collaborator:
International Network for Cancer Treatment and Research
Information provided by (Responsible Party):
International Atomic Energy Agency

Brief Summary:

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

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Radiation: Radiotherapy
RT 40 Gy in 15 fractions




Primary Outcome Measures :
  1. Local control. [ Time Frame: 4 years ]
    The presence/absence of recurrent disease in the surgical scar, ipsilateral chest wall, ipsilateral skin and soft tissue.

  2. 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.

  3. Overall survival. [ Time Frame: 4 years ]
  4. Disease-free survival. [ Time Frame: 4 years ]
  5. Acute adverse events. [ Time Frame: 4 years ]
    During treatment and up to 90 days following the completion of treatment.

  6. Late adverse events. [ Time Frame: 4 years ]
    More than 90 days after the completion of radiation therapy.


Secondary Outcome Measures :
  1. Patients' demographics. [ Time Frame: 4 years ]
  2. Reproductive history. [ Time Frame: 1 year ]
    Number of pregnancies, miscarriages. Menstrual History.

  3. Family history. [ Time Frame: 1 year ]
    Family history of breast cancer.

  4. Characterization of molecular profile of breast cancer patients. [ Time Frame: 4 years ]


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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be older than 18 and less than 81 years of age
  2. WHO (ECOG) Performance Status of 0-2
  3. Histologically confirmed diagnosis of infiltrating ductal carcinoma of the breast, lobular carcinoma or mixed (ductal and lobular) type.

    Note: Tumor diagnosis will be performed at the participating center according to the center's routine procedures.

  4. Patients must have had a modified radical mastectomy (MRM) in which 6 or more axillary nodes were removed.
  5. All patients should receive adjuvant chemotherapy following MRM. The initiation of radiation therapy must allow for the full recovery of blood counts (WBC > 3.0 x 109/L, Granulocytes > 1.5 x109/L and platelets > 75 x 109/L).

    Note: MRM should have been performed at maximum 3 months prior to the start of adjuvant chemotherapy.

    Special Note: Patients who have not received adjuvant chemotherapy will be required to receive adjuvant chemotherapy as per Appendix 3 prior to study entry and initiation of radiotherapy must allow for the full recovery of blood counts (WBC > 3.0 x 109/L, Granulocytes > 1.5 x109/L and platelets > 75 x 109/L MRM should have been performed within 3 months prior to the start of adjuvant chemotherapy.

  6. Patients must have received adjuvant chemotherapy according to one of the two regimens found in Appendix 3.
  7. Negative surgical margins by histopathology at the time of MRM. Note: Negative surgical margins means that there are no cancer cells at the inked margin of resection or otherwise at the margins of the mastectomy specimen.
  8. The following indicators in the histological samples must be known :

    1. Tumor size
    2. Tumor site (quadrant, central, axillary tail)
    3. Presence of extensive intraductal component (EIC)
    4. Estrogen and Progesterone Receptor Status and the method of staining and detection.
    5. HER2 Status (optional), if given, the method must be provided.
  9. Patients with the following TNM stages, all being M0: pT1 N1, pT2 N1, pT3 N0, pT0 N2, pT1 N2, pT2 N2, T3 N1, pT3 N2 (see Appendix 4 for TNM Stage)
  10. Histological grades 1 - 3 (as per WHO criteria)
  11. Patients must consent to return for scheduled treatments and follow up.
  12. Written informed consent document signed

Exclusion Criteria:

  1. Pathological pN3 (metastasis in 10 or more lymph nodes, clinically apparent internal mammary metastasis, metastasis in the supraclavicular lymph nodes)
  2. Stages IIIB, IIIC and IV (any T4, any N3 or M1)
  3. Recurrence of breast cancer following MRM and/or adjuvant chemotherapy.
  4. Concomitant primary cancer in the contralateral breast.
  5. History of other malignancy except carcinoma in situ of the cervix or non-melanoma skin cancer
  6. Pregnant or breast-feeding
  7. Previous chemotherapy other than adjuvant chemotherapy for treatment of the present breast cancer
  8. Other severe concomitant disease that could impact upon the ability to deliver treatment or increase the risk of toxicity (such as uncompensated congestive heart failure, unstable coronary heart disease, uncompensated chronic obstructive pulmonary disease, collagen vascular diseases including systemic lupus erythematosus, systemic sclerosis, dermatomyositis, and ataxia telangiectasia).
  9. Contraindications to radiation therapy (such as previous irradiation of the breast or chest wall)
  10. Severe psychiatric disorder that may interfere with the process of informed consent and/or treatment or follow-up compliance.

Information from the National Library of Medicine

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


Contacts
Contact: Eduardo Rosenblatt, MD (43 1) 2600-21669 ext 21669 e.rosenblatt@iaea.org
Contact: Eeva K. Salminen, Section Head (43 1) 2600-26511 ext 26511 e.salminen@iaea.org

Locations
Cuba
Instituto Naciolal de Oncologia y Radiobiologia (INOR) Recruiting
Havana, Cuba, 10400
Contact: Jorge M. Marinello, MD       poliva@infomed.sld.cu   
Principal Investigator: Jorge M. Marinello, MD         
Egypt
Cairo National Cancer Institute Recruiting
Cairo, Fom El-Khalig, Egypt, 11796
Contact: Magda M. El-Mongy, MD    +20-101-714805    magdamongi@yahoo.com   
Principal Investigator: Magda M. El-Mongy, MD         
Alexandria Ayadi Almostakbal Oncology Cenre. Recruiting
Alexandria, Egypt
Contact: Ahmed Elzawawy, MD    +20-66-33-32-758    icedoc@nilesat.net   
Principal Investigator: Ahmed Elsawawy, MD         
Ghana
Korle Bu Teaching Hospital Recruiting
Accra, Ghana
Contact: Verna Vanderpuye, MD    +233-21-676222/669202    vanaglat@yahoo.com   
Principal Investigator: Verna Vanderpuye, MD         
Morocco
Institut National d'Oncologie Recruiting
Rabat, Morocco, 10100
Contact: Mansouri Aziz, MD       a.mansouri@gmx.net   
Principal Investigator: Mansouri Aziz, MD         
Nigeria
University of Ibadan College Hospital Recruiting
Ibadan, Nigeria
Contact: Oladapo B. Campbell, MD    +234-803    dapocampbell@yahoo.com   
Principal Investigator: Oladapo B. Campbell, MD         
Pakistan
Institut of Radiotherapy and Nuclear Medicine (IRNUM) Recruiting
Peshawar, Pakistan, 25120
Contact: Safoora Shahid, MD    0092-91-9216114    irnum@psh.paknet.com.pk   
Principal Investigator: Safoora Shahid, MD         
Peru
Instituto Nacional de Enfermedades Neoplasicas Recruiting
Lima, Peru, 34
Contact: Jorge A. Moscol_Ledesma, MD    +51-1-4499137    jamoscol@hotmail.com   
Principal Investigator: Jorge A. Moscol-Ledesma, MD         
Turkey
Cerraphasa Medical Faculty Recruiting
Istanbul, Turkey, 34303
Contact: Nuran Bese, MD    +90-532-4680805    nuranbese@superonline.com   
Principal Investigator: Nuran Bese, MD         
Sponsors and Collaborators
International Atomic Energy Agency
International Network for Cancer Treatment and Research
Investigators
Study Chair: Eduardo Rosenblatt, MD International Atomic Energy Agency

Additional Information:
Publications:
Responsible Party: International Atomic Energy Agency
ClinicalTrials.gov Identifier: NCT01452672     History of Changes
Other Study ID Numbers: E3.30.25
First Posted: October 17, 2011    Key Record Dates
Last Update Posted: October 17, 2011
Last Verified: October 2011

Keywords provided by International Atomic Energy Agency:
Breast cancer
Radiotherapy
Post-mastectomy
Molecular characterization

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases