Trans Tasman Radiation Oncology Group (TROG) 09.01 - A Phase II Trial to assess the tolerability of Integrated Preoperative Radiotherapy and Chemotherapy with Oxaliplatin 5-Flurouracil (5-FU) and Folinic Acid in Patients with Locally Advanced Rectal Cancer

Trans Tasman Radiation Oncology Group (TROG)0 个研究点目标入组 40 人开始时间: 2010年2月25日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Patients may be included in the trial only if they meet all of the following criteria
•1. Previously untreated and pathologically proven adenocarcinoma of the rectum.
•2. MRI staged T3 or T4, any N.
•3. Lower border of tumour must be within 12 cm of anal verge.
•4. Age = or > 18 years.
•5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
•6. Absolute neutrophil count > 1.5×109/L, haemoglobin > 90 g/L, and platelets > 100×109/L.
•7. Adequate renal function: Glomerular Filtration Rate (GFR) > 55mL/min (derived from serum creatinine e.g. using the Cockcroft-Gault formula or measured by radioisotopic techniques).
•8. Bilirubin and Alanine aminotransferase (ALT) < or = 1.5 x upper limit of normal.
•9. No symptomatic peripheral neuropathy > grade 2.
•10. Male or non-pregnant, non-lactating female. Patients on study with reproductive potential, or female partners with reproductive potential, must use an effective contraceptive.
•11. Has provided written informed consent for participation in this trial

•Patients who fulfill any of the following criteria are not eligible for admission to the trial:
•1. Presence of metastatic disease.
•2. Prior pelvic radiotherapy
•3. Febrile intercurrent illness or infection.
•4. Previous history of unstable angina
•5. Cardiac arrhythmia which in the opinion of the investigator would compromise the safe delivery of protocol treatment
•6. Acute coronary syndrome even if controlled with medication
•7. Myocardial infarction within the last 12 months
•8. Concurrent treatment with other anti-cancer therapy.
•9. Significant medical condition which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.
•10. Locally recurrent rectal cancer.

发起方

Trans Tasman Radiation Oncology Group (TROG)