Comparing short and standard radiation therapy for breast cancer treatment
Hypofractionated Radiation Therapy (1 Week) Compared With Standard Treatment (3.1 Weeks), Evaluation of Local Control of Breast Cancer Treated With Conservative Surgery.
This study is testing if a shorter week-long radiation treatment for early-stage breast cancer works as well as the standard three-week treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Coordinación de Investigación en Salud, Mexico Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Mérida, Yucatán) |
| Trial ID | NCT05318274 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of hypofractionated radiation therapy, which involves a shorter treatment schedule of one week, against the standard treatment schedule of 3.1 weeks for patients with ductal carcinoma in situ and early-stage invasive breast cancer. The primary objective is to evaluate local tumor control and survival rates, while secondary objectives include assessing tumor characteristics, recurrence rates, toxicity levels, and quality of life. Patients will be randomized into two groups to receive either treatment, and various outcomes will be measured over time.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years diagnosed with ductal carcinoma in situ or early-stage invasive breast cancer who have undergone breast-conserving surgery.
Not a fit: Patients with positive lymph nodes, advanced tumor stages (T3-T4), or those with a history of previous irradiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide patients with effective treatment in a shorter time frame, potentially reducing side effects and improving quality of life.
How similar studies have performed: Other studies have shown promising results with hypofractionated radiation therapy, suggesting that this approach may be effective, though this specific comparison is less common.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed by histopathological report of ductal carcinoma in situ (DCIS) or invasive breast carcinoma. * Treated with breast-conserving surgery and stage pT1-2 pN0 M0. * Over 18 years. * Patients who sign informed consent for research study. Exclusion Criteria: * Positive nodes. * Clinical or pathological stage T3-T4. * History of previous irradiation. * Postoperative positive margin.
Where this trial is running
Mérida, Yucatán
- Unidad Medica de Alta Especialidad — Mérida, Yucatán, Mexico (Recruiting)
Study contacts
- Principal investigator: Fernando H Castillo-Lopez, Phy. — Instituto Mexicano del Seguro Social
- Study coordinator: Patricia B Bolado-García, MD.
- Email: investigacion.umae.imss@gmail.com
- Phone: 9994695696
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.