Other Clinical Trial - Ultra-hypofractionated for Whole Breast Irradiation

Status Recruiting

Clinical Trial Summary

Female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. One group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 Gy in 5 fractions. In contrast, the other group will receive partial breast irradiation with a dose of 26Gy in 5 fractions. The study's objective is to compare the effects of both breast radiotherapy protocols in terms of locoregional disease control and survival and to compare the adverse effects of radiotherapy between the two protocols. To determine if there is a correlation between different parameters and the efficacy and degree of toxicity for both protocols.

Clinical Trial Description

Radiation therapy should ideally start 6-8 weeks after breast-conserving surgery but no later than 12 weeks after the surgery. If adjuvant chemotherapy has been administered, it is recommended to start radiation therapy three weeks after chemotherapy (optionally, it can be completed before beginning chemotherapy). The radiation therapy procedure follows the existing clinical protocol for breast radiotherapy. For radiation therapy planning, the patient is positioned supine using immobilization devices (such as a wing board or similar) to ensure daily reproducibility within a range of 5 mm. The clinical target volume (CTV) is delineated according to the recommendations of the Danish Breast Cancer Cooperative Group (DBCG) and the European Society for Radiotherapy and Oncology (ESTRO). A total dose of 26Gy in 5 fractions every working day using the Volumetric Modulated Arc Therapy (VMAT) technique. Daily portal images are obtained, and a breathing control protocol is applied based on clinical assessment (for left breast radiation therapy, active breath control is used - in deep inspiration or respiratory gating). ;

Study Design

Related Conditions & MeSH terms

Breast Cancer Female

Clinical Trial Details

NCT number	NCT05914831
Study type	Interventional
Source	Oncology Institute of Vojvodina
Contact	Olivera Ivanov
Phone	0214805496
Email	ivanov.olivera@onk.ns.ac.rs
Status	Recruiting
Phase	Phase 2
Start date	June 1, 2023
Completion date	May 31, 2033

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03080623` - Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
Completed	`NCT05527769` - Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
Completed	`NCT06376578` - Exercise Interventions for Improving Health in Breast Cancer Survivors	N/A
Completed	`NCT03004534` - A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide	Early Phase 1
Recruiting	`NCT05020574` - Microbiome and Association With Implant Infections	Phase 2
Active, not recruiting	`NCT06277141` - The Vitality Mammography Messaging Study	N/A
Completed	`NCT03555227` - USG PECS vs LIA for Breast Cancer Surgery	N/A
Completed	`NCT03270111` - High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women	N/A
Active, not recruiting	`NCT03917082` - Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer	Phase 2
Recruiting	`NCT05561842` - Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)
Completed	`NCT04554056` - Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF	Phase 2/Phase 3
Active, not recruiting	`NCT03127995` - Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence	N/A
Active, not recruiting	`NCT02237469` - Prone Breast Radiotherapy Treatment Planning Observational Study
Completed	`NCT01204125` - Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients	Phase 2
Recruiting	`NCT04565054` - Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC	Phase 3
Not yet recruiting	`NCT06412133` - Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients	N/A
Recruiting	`NCT03956641` - Evolution of the Physical Condition in Treated Cancer Patients	N/A
Recruiting	`NCT06087120` - Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
Recruiting	`NCT06058936` - Exercises Using Virtual Reality on Cancer Patients	N/A
Completed	`NCT03470935` - Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms