TROG 12.02 PET Scans for Locally Advanced Breast Cancer and Diagnostic MRI to Determine the Extent of Operation and Radiotherapy

TROG0 个研究点目标入组 24 人开始时间: 2013年3月4日最近更新: 2023年9月12日

适应症

试验速览

暂无简介。

•1. Cytological + / - Histological confirmation of disease within 28 days prior to registration
•2. Clinical Stage III (non-inflammatory) unilateral breast cancer
•3. Adequate haematological, renal and hepatic function as defined by:
•a) Absolute neutrophil count (ANC, segs + bands) > / =1.5 x 109 / L
•b) Platelet count > / = 100 x 109 / L
•c) Total Bilirubin > / = 1.5 x upper normal limit
•d) Alaninie aminotransferase (ALT) < / = 2.5 x upper normal limit
•e) EGFR >30ml/min
•4. Women must be suitable for radical treatment employing chemotherapy, surgery, radiation therapy + / - trastuzumab + / - hormonal therapy
•5. A ECOG performance status score of 1 or less within 28 days prior to registration
•6. No contraindications to receiving radiation treatment
•7. Life expectancy greater than 36 months
•8. Participants capable of childbearing are using adequate contraception.
•9. Available for follow up
•Patients may proceed to protocol treatment if they meet the following criteria:
•10. Adequate cardiac function as defined by a left ventricular ejection fraction of >50%, unless patient is enrolled on a study of primary endocrine therapy.
•11. Patients who have no metasteses on PET CT scan OR PET-CT scan identifies up to 3 sites of metastases only.

•1. Women who are pregnant or lactating
•2. Women who are unwilling to have photographs taken of the area from the mid-neck to navel at specified time-points throughout the study.
•3. Women with implanted medical or electronic devices deemed by the MRI radiologist to be a contra-indication to performing a breast MRI, for example: implanted defibrillator, cardiac pacemaker, a cochlear implant, implanted drug infusion port, a metallic joint prosthesis, nerve stimulators, metal pins, screws, plates, stents or surgical staples
•4. Clinical evidence of bilateral breast cancer
•5. Previous RT to the area to be treated
•6. Previous chemotherapy
•7. Previous surgery to the ipsilateral breast or nodes
•8. Previous contralateral breast cancer
•9. Prior diagnosis of cancer with subsequent evidence of disease recurrence or clinical expectation of recurrence is greater than 10% within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
•10. Patients with clinical evidence of metastatic disease.

发起方

TROG