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

Last updated: February 7, 2021
Sponsor: Blokhin's Russian Cancer Research Center
Overall Status: Active - Enrolling

Phase

3

Condition

Anal Dysplasia

Carcinoma

Lung Cancer

Treatment

N/A

Clinical Study ID

NCT02526953
SCAC-001
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • inability to obtain informed consent
  • distant metastases
  • synchronous or metachronous tumors
  • previous chemotherapy or radiotherapy
  • clinically significant cardiovascular disorders (myocardial infarction < 6 monthsbefore visit, stroke < < 6 months before visit, instable angina < 3 months beforevisit, 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 orunderstand his/her condition
  • technical inability to perform pelvic MRI
  • inability of long-term followup of the patient

Study Design

Total Participants: 314
Study Start date:
January 01, 2016
Estimated Completion Date:
October 31, 2022

Study Description

This trial aims to investigate the efficacy of chemoradiotherapy with or without paclitaxel in squamous-cell anal cancer. This is a prospective multicenter open-label randomized phase III clinical trial. Patients will be randomized using an online randomization system to receive either standard IMRT with capecitabine and mitomycin or IMRT with capecitabine, mitomycin and paclitaxel. A stratification will be performed based on T stage, N stage and clinical center. Doses of capecitabine and mitomycin in experimental group were reduced for better treatment tolerance. The target accrual is 157 patients in each treatment arm (including 10% potential data loss) based on potential benefit of 15% 3-yr disease-free survival (70% vs 85%), α=0,05, power 80% in the experimental arm. An interim analysis is planned after 50% of the patients will reach a 3-year followup. Pelvic Magnetic Resonance Imaging (MRI) is performed in all patients for staging and followup. Pelvic MRI and histological diagnosis are subject to central review. Conduction of this study and data collection are controlled by a local institutional board.