Breast cancer

Breast Cancer

Title: Acute skin toxicity and cosmesis outcome in ultrahypofractionated radiotherapy for non-metastatic breast cancer treated with proton radiotherapy compared with photon radiotherapy: a randomized control trial phase ll.  

Trial status: recruiting

First posted: 30 January 2023

Last updated: 30 January 2023

 

Purpose
Nowadays, the main treatment for breast cancer includes surgery, chemotherapy, targeted treatment, and radiotherapy. Radiotherapy after surgery has reduced the recurrence rate and mortality rate of the disease. Over the past 10 years, the standard treatment for early breast cancer in many countries, including King Chulalongkorn Memorial Hospital, has been reducing the number of doses of radiation from 50-60 Gray in 25-30 days to 40.5 Gray in 15 days, known as “hypofractionation.” Studies conducted in various countries have shown that this hypofractionation has no impact on disease control, making it more convenient for patients by reducing the number of visits to the hospital and increasing access to radiation treatment for new patients. In the past 5 years, the number of radiation doses for early breast cancer patients has been reduced to 26 Gray in 5 days. To determine the optimal radiation dose that would most benefit the patient, a recent study from the UK showed that this reduced dose of 26 Gray over 5 days was not inferior to the hypofractionation method of 40.5 Gray over 15 days and had no significant difference in terms of side effects, with minimal acute dermatitis. King Chulalongkorn Memorial Hospital has also introduced a radiation service using proton therapy, which is the first machine of its kind in Thailand. This proton therapy is superior to the current photon irradiation in terms of reducing side effects on surrounding organs and tissues, particularly for the treatment of breast cancer, where the heart and lungs are nearby.

This research is a comparative study between photon and proton irradiation. The objectives of this study are:

  1. To assess acute skin toxicities in PRT when using ultrahypofractioned radiation in non-metastatic breast cancer compare to photon beam radiotherapy.
  2. To evaluate the LRR of non-metastatic breast cancer after treated by the PRT with ultrahypofractioned radiation compare to photon beam radiotherapy.
  3. To evaluate the cosmetic outcome of the PRT when using ultrahypofractioned radiation in non-metastatic breast cancer compare to photon beam radiotherapy.
  4. To evaluate the late toxicities and late cosmetic outcome of the PRT when using ultrahypofractioned radiation compare to photon beam radiotherapy.

 

Sample size 140 patients

Eligibility:

Inclusion criteria:

  • Female patients who diagnosed with pathologically proven breast cancer and have undergone either mastectomy or lumpectomy with axillary lymph node dissection or sentinel lymph node biopsy.
  • Stage 1-3 (According to AJCC 8th edition)[21] (Appendix 6)
  • Aged ≥ 21years.
  • ECOG performance status 0-2 (asymptomatic or symptomatic but capable for self-care) within 90 days prior to randomization.

Exclusion criteria:

  • Prior radiotherapy to the ipsilateral chest wall or ipsilateral breast/thorax.
  • Any radiation therapy for the currently diagnosed breast cancer prior to randomization.
  • Any active skin problem on chest wall and axillary area or connective tissue disease.
  • Other non-malignant systemic disease that would prevent the patient from receiving study treatment or required follow-up including pregnancy or lactating.
  • Surgical margin positive.
  • Bilateral breast cancer.

 

Phase II

Disease Status : Stage I-III

Investigator

  • Chawalit Lertbutsayanukul
  • Thanaporn Sarsitthithum
  • Chonnipa Nantavithya
  • Kitwadee Saksornchai

Diseases : Breast cancer

Locations : King Chulalongkorn Memorial hospital