NCT04959474Toboroz
Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer
SABR-CaRe: A Phase II Randomized Trial of Pre-Operative Stereotactic Ablative Radiation Therapy (SABR) With and Without Caloric Restriction for Early Stage Breast Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jan. 23.
Rövid összefoglaló (regiszter, angolul)
This phase II trial studies the effect of calorie reduction while undergoing stereotactic ablative radiation therapy in treating patients with breast cancer. Stereotactic ablative radiation therapy (sABR) is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organ. Giving SABR before surgery may make the tumor smaller. Adding dietary restrictions in combination with radiation therapy may help increase local control and decrease the spread of the cancer to other places in the body. The purpose of this trial is to identify if there is a decrease in tumor tissue in patients undergoing caloric restriction during pre-operative SABR, compared to patients undergoing pre-operative SABR alone.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 80 (tervezett)
- Első benyújtás
- 2021. ápr. 27.
- Kezdés
- 2021. aug. 23.
- Elsődleges befejezés
- 2028. nov. 1.
- Fő szponzor
- Thomas Jefferson University
- Betegségek
- Tripla negatív emlőrák
- NCT-szám
- NCT04959474
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 80
- 2021. aug. 23. és az elsődleges befejezés (2028. nov. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Patient has stage IV metastatic disease
- Patients with oligo-metastatic disease who are being treated with curative intent per the treating physician will not be excluded if all other eligibility criteria are met
- Previous breast radiation on ipsilateral side
- Any prior treatment with radiation therapy or chemotherapy for the current breast cancer diagnosis prior to registration
Más betegség
- Paget's disease of the nipple
- Patients with significant psychiatric illness that would preclude them from adhering to the protocol in the judgement of the treating clinician
Egyéb
- Patient is clinically node positive: clinically suspicious axillary lymph node(s) by axillary US or exam unless biopsied and found to be negative
- Breast tumor size is > 3.0 cm
- Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor
- Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign
- BMI < 21 at the time of study enrollment
Kiket keres a vizsgálat
- • Patients with pathologically proven DCIS or invasive breast cancer histologies
- Willing and able to provide informed consent
- Willing and able to comply with study treatments including dietary intervention
- Body mass index (BMI) >= 21 at time of enrollment
- Age >= 40 years at time of consent
- Patients with triple negative breast cancer (TNBC) must be >= 50 years of age at time of consent
- Karnofsky performance status (KPS) score 70 - 100
- Tumor size =< 3.0 cm
- Gross disease within the breast must be unifocal
- Gross disease may be multifocal as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension =< 3 cm
- Patients with invasive disease are required to have clinical axillary staging including axillary ultrasound (US) that proves patient is clinically node negative or can be done by physical examination if the patient is over 70
- Patient is not being considered for preoperative chemotherapy
- Must be English or Spanish speaking
Életkor a regiszterben: 40 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
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| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.