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Tests treatment safety and results for Breast Cancer
Official title Patient-Reported Outcome and Safety Between Preoperative and Postmastectomy Radiotherapy in DIEP Flap Reconstruction
ClinicalTrials.gov ID: NCT05512286
What this study is testing
- What it's testing
- This study is the first prospective randomized study assessing the patient-reported outcomes and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction of deep inferior epigastric perforator(DIEP) flap. Radiotherapy before mastectomy and autologous free-flap breast reconstruction can avoid adverse radiation effects on healthy donor tissues and delays to adjuvant radiotherapy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients with histological proven invasive breast cancer;
- Clinical T0-3, T4b and N0-3a disease who require neoadjuvant chemotherapy;
- No distant metastasis;
- Adjuvant radiotherapy and who are suitable for DIEP flap reconstruction at the time of mastectomy.
You likely can't join if
- Patients enrolled in other clinical trial which may as influence the outcome;
- Patients received neoadjuvant therapy without radiotherapy indications；
- Disease progression during neoadjuvant chemotherapy；
- Patients of pregnancy or lactation；
- Previous history of diabetes；
- Previous history of heavy smoking.
The study team makes the final eligibility decision.
Where it's taking place
- Nanning, Guangxi, China
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Shanghai, Shanghai Municipality, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanning, Guangxi, China; Zhengzhou, Henan, China; Changsha, Hunan, China; Shanghai, Shanghai Municipality, China; Kunming, Yunnan, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.