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

NCT02526953 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2021-02-09

No results posted yet for this 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.

Conditions

  • Anus Neoplasms
  • Carcinoma, Squamous Cell
  • Anus Diseases
  • Neoplasms
  • Neoplasms, Squamous Cell
  • Carcinoma

Interventions

DRUG

Paclitaxel

45 mg/m2, IV, weekly during the radiation. Number of infusions: 5.

DRUG

Capecitabine

625 mg/m2, bid, per os, only on days of radiation (Monday through Friday)

DRUG

Capecitabine

825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)

DRUG

Mitomycins

10 mg/m2, IV, on day 1. Number of infusions: 1.

DRUG

Mitomycins

12 mg/m2, IV, on day 1. Number of infusions: 1.

RADIATION

Radiotherapy

Dose: 44 Gy on regional nodes, 52-58 Gy on primary tumor, based on T stage

Sponsors & Collaborators

  • Blokhin's Russian Cancer Research Center

    lead OTHER

Principal Investigators

  • Arsen O Rasulov, PhD · N.N.Blokhin Russian Cancer Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2021-10-31
Completion
2022-10-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02526953 on ClinicalTrials.gov