Efficacy Study of Chemoradiotherapy With or Without Paclitaxel in Squamous-cell Anal Carcinoma Patients
Anus Neoplasms, Carcinoma, Squamous Cell, Anus Diseases
About this trial
This is an interventional treatment trial for Anus Neoplasms focused on measuring anal cancer, chemoradiation, intensity-modulated radiotherapy, paclitaxel
Eligibility Criteria
Inclusion Criteria:
- Informed consent
- Histologically verified squamous-cell anal cancer
- Stage I-IIIB (Union for International Cancer Control (UICC) TNM classification v7)
- Eastern Cooperative Oncology Group (ECOG) status 0-2
- HIV (Human Immunodeficiency Virus) negative
- Haemoglobin (HGB) > 90 g/L
- Platelet Count (PLT) > 120x10*9/L
- Serum creatinine < 150 µmol/L
- Total bilirubin < 25 µmol/L
Exclusion Criteria:
- inability to obtain informed consent
- distant metastases
- synchronous or metachronous tumors
- previous chemotherapy or radiotherapy
- clinically significant cardiovascular disorders (myocardial infarction < 6 months before visit, stroke < < 6 months before visit, instable angina < 3 months before visit, arrhythmia, uncontrolled hypertension > 160/100 mm hg
- clinically significant neurological disorders
- previous neuropathy 2 or higher
- current infection or heavy systemic disease
- pregnancy, breastfeeding
- ulcerative colitis
- individual intolerance to treatment components
- proven dihydropyrimidine dehydrogenase (DPD) deficiency
- participation in other clinical trials
- psychiatric disorders, which render patient unable to follow instructions or understand his/her condition
- technical inability to perform pelvic MRI
- inability of long-term followup of the patient
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Paclitaxel
Standard
Patients will receive intensity-modulated radiotherapy with dose based on T stage. The planned doses to the primary tumor and pelvis are 52-58 Gy and 44 Gy, respectively.The concurrent chemotherapy regimen will consist of paclitaxel 45 mg/m2 on days 3,10,17,24,31, capecitabine 625 mg/m2 bid on treatment days and mitomycin C 10 g/m2 on day 1.
Patients will receive intensity-modulated radiotherapy with dose based on T stage. The planned doses to the primary tumor and pelvis are 52-58 Gy and 44 Gy, respectively.The concurrent chemotherapy regimen will consist of capecitabine 825 mg/m2 bid on treatment days and mitomycin C 12 g/m2 on day 1.