Study of Prone Accelerated Breast And Nodal IMRT
Condition: Lymphedema
MeSH terms: Lymphedema
Study type: Interventional

Summary: 
      Following consent, patients will receive 15 fractions of radiotherapy to the affected breast
      and to Axillary level III and SCV (Supra-Clavicular) lymph nodes, defined by CT imaging
      obtained in a prone position using IMRT(intensity modulation radiation therapy ) technique:
      one fraction daily for 5 days/week for 3 consecutive weeks. Patients will be seen for
      follow-up at 45-60 days from first radiotherapy treatment, and then yearly. Patients will be
      assessed for Lymphedema at baseline, end of treatment, and at yearly intervals after
      completion of radiotherapy. All patients will be followed for toxicity and outcome (local and
      systemic recurrence, survival). In addition, patients will complete a self-assessment of QOL
      at baseline, week 3, day 45-60 and 2-yr follow-ups.
    

Detailed description: 
      A recent Cochrane Collaboration Intervention Review has addressed the effects of altered
      fractionation size on women with early breast cancer who have undergone breast conservation
      surgery. Analysis of two prospective randomized trials that included 2644 women, selected
      based on tumor size less than five cm, negative pathological margin of excision and negative
      lymph nodes. No difference in clinical outcome was detected. The conclusion of the review is
      that the use of unconventional fractionation regimens (greater than 2 Gy per fraction) does
      not affect breast appearance or toxicity, and does not seem to affect local recurrence or
      five years survival rates.

      After breast surgery and an adequate axillary dissection (i.e., at least 8 nodes retrieved in
      the axillary dissection specimen from level I and II) it is possible to identify patients
      with 1 - 5 positive nodes who require radiotherapy to both the indexed breast/chest wall and
      the draining nodal stations that the surgeon did not include in the traditional level I - II
      axillary dissection, i.e., level III and supraclavicular stations. We are proposing to test a
      new technique that extends prone set up to also include these lymph node regions. Limiting
      treatment to the supraclavicular fossa and level III axilla in patients with an adequately
      dissected axilla is supported by several published studies. Regional nodal recurrences are
      rare (occurring in 1 - 5%) in patients with early stage invasive breast cancer who have
      undergone breast conserving therapy. Several institutions choose to treat only the level III
      axilla and supraclavicular nodal stations in patients who have undergone surgical treatment
      of level I/II axilla. This technique was documented recently by Liengsawangwong, who utilized
      CT-delineated nodal stations to improve target coverage of SCV (Supra-Clavicular) and level
      III axillary nodes in patients who had undergone axillary level I/II dissection and were
      found to have positive lymph nodes.
    

Intervention name(s): Intensity-modulated radiation therapy (IMRT)
Intervention type(s): Radiation
Intervention description(s): Patients will receive 15 daily radiation fractions of 2.7 Gy, Monday to Friday for three weeks, to the entire breast/chest wall and axillary level III and supraclavicular nodes with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7 Gy + 0.5 Gy). The overall dose will be 40.5 Gy to the breast/chest wall, axillary level III and supraclavicular nodes, and 48.0 Gy to the tumor bed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prone IMRT to breast, level III & Supraclavicular; acute toxicity of prone IMRT to breast, level III & SCV