Overview

Efficacy Study of Chemoradiotherapy With or Without Paclitaxel in Squamous-cell Anal Carcinoma Patients

Status:
Enrolling by invitation
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether the combination of paclitaxel, capecitabine, mitomycin and intensity-modulated radiotherapy is more effective than the standard combination of capecitabine, mitomycin and intensity-modulated radiotherapy (IMRT) in patients with squamous-cell anal cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Blokhin's Russian Cancer Research Center
Treatments:
Albumin-Bound Paclitaxel
Capecitabine
Mitomycin
Mitomycins
Paclitaxel
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