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Robustness Evaluation of Deep Inspiration Breath-Hold (DIBH) Radiotherapy Plans for Internal Mammary Irradiation in Postoperative Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Observational
SUMMARY

This study is an investigator-initiated, single-arm, single-center, prospective, observational study. The hypothesis is that during the implementation of deep inspiration breath-hold (DIBH) radiotherapy plans in postoperative breast cancer patients receiving internal mammary irradiation, the actual target dose coverage and organ-at-risk (OARs) dose parameters remain within clinically acceptable ranges.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
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• Provide a signed and dated informed consent form (ICF) before the initiation of any trial-specific procedures.

• Female patients aged ≥ 18 years.

• Histologically confirmed invasive breast cancer.

• Have received breast-conserving surgery or mastectomy with axillary staging, including sentinel lymph node biopsy and/or axillary lymph node dissection.

• Able to hold breath for more than 30 seconds after deep inspiration.

• Planned to receive postoperative radiotherapy targeting regional lymph nodes, including the internal mammary nodes, under DIBH conditions.

• Planned to undergo moderate hypofractionated radiotherapy.

• Karnofsky Performance Status (KPS) score ≥ 80.

• The estimated life expectancy of greater than 5 years .

⁃ Sufficient wound healing from surgery, with no signs of active infection at the intended radiation site.

Locations
Other Locations
China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Lu Cao, PhD
cl11879@rjh.com.cn
+86-021-64370045
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 25
Treatments
Arm1: 3 mm Gating Window Group
Participants will receive regional nodal and internal mammary irradiation using a hypofractionated regimen and the DIBH technique, with a respiratory gating tolerance of ±1.5 mm (a total of 3 mm).
Arm2: 2 mm Gating Window Group
Participants will receive regional nodal and internal mammary irradiation using a hypofractionated regimen and the DIBH technique, with a respiratory gating tolerance of ±1.0 mm (a total of 2 mm).
Arm3: 1.5 mm Gating Window Group
Participants will receive regional nodal and internal mammary irradiation using a hypofractionated regimen and the DIBH technique, with a respiratory gating tolerance of ± 0.75 mm (a total of 1.5 mm).
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov

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