Simultaneous Integrated Boost Radiation Therapy with concomitant Capecitabine and Mitomycin-C chemotherapy for locally advanced Anal Carcinoma - SIBRT, capecitabine and mitomycin-C for locally advanced anal carcinoma

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•1. Patients with histologically or cytologically confirmed primary advanced anal carcinoma with tumor (T), nodal (N) and metastases (M) stage:
•- T2 (>4 cm) - T3 - T4 / N0 - 1 / M0
•- T1 - 4 / N2 - 3 / M0
•2. Previous (neo)adjuvant chemotherapy > 12 months ago is allowed. Otherwise patients should be chemonaive.
•3. Measurable or evaluable non-measurable disease
•4. Age 18 years or older
•5. Able to swallow and retain oral medication
•6. Able and willing to undergo blood sampling for pharmacokinetic and pharmacogenetic analysis
•7. Life expectancy of at least 3 months allowing adequate follow up of toxicity evaluation and antitumor activity
•8. Minimal acceptable safety laboratory values defined as:
•a) ANC >= 1.5 x 10**9/L
•b) Platelet count >= 100 x 10**9/L
•c) Haemoglobin level >= 6.0 mmol/l or higher - prior transfusion is permitted
•d) Hepatic function as defined by serum bilirubin 1.5 x ULN or less, ALT and AST and alkaline phosphatase 2.5 x ULN or less
•e) Renal function as defined by serum creatinine <= 1.5 x ULN or creatinine clearance >= 50 ml/min (by Cockcroft-Gault formula).
•9. Able and willing to give written informed consent
•10. WHO performance status of 0 - 2

•1. Known CNS or leptomeningeal metastases (a CT or MRI scan should be done if there is a clinical suspicion of CNS metastases)
•2. History of another metastasized cancer less than 5 years ago
•3. Uncontrolled infectious disease or known hepatitis B or hepatitis C patients
•4. HIV patients treated with HAART
•5. Previous radiotherapy to the pelvic and/or unguinal region
•6. Uncontrolled cardiovascular disease
•7. Previous severe fluoropyrimidine toxicity
•8. DPYD*2A mutation present
•9. Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up
•10. Women who are pregnant or breast feeding
•11. Women of childbearing potential who refuse to use a reliable contraceptive method throughout the study
•12. Any other medical condition that would interfere with study procedures and/or decrease safety of the protocol treatment

发起方

Antoni van Leeuwenhoek Ziekenhuis