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International Multicentre Study in Advanced Anal Cancer Comparing Cisplatin Plus 5 FU vs Carboplatin Plus Weekly Paclitaxel

NCT02051868 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-11-04

No results posted yet for this study

Summary

Anal cancer is a relatively uncommon disease and there is currently no standard chemotherapy treatment for patients with inoperable locally recurrent or metastatic disease. The aim of this phase II study is compare two well known and largely used chemotherapy regimens - Cisplatin plus 5-fluorouracil vs Carboplatin plus Paclitaxel. The result of this study will set a standard of care for this disease and provide useful information for future Phase III trials.

Conditions

  • Squamous Cell Carcinoma of the Anus

Interventions

DRUG

Cisplatin

Cisplatin 60 mg/m2 as a 1 hour i.v. infusion once every 3 weeks.

DRUG

5-Fluorouracil (5-FU)

5-FU 1000 mg/m2/24h as a 96-hour continuous infusion over days 1 to 4 every 3 weeks.

DRUG

Carboplatin

Carboplatin 1-hour i.v. infusion to an area under the curve (AUC) of 5 once every 4 weeks.

DRUG

Paclitaxel

Paclitaxel 80 mg/m2 as a 1-hour i.v. infusion on day 1,8 and 15 of each (4-weekly) cycle.

Sponsors & Collaborators

  • Cancer Research UK

    collaborator OTHER

  • Australasian Gastro-Intestinal Trials Group

    collaborator NETWORK

  • ECOG-ACRIN Cancer Research Group

    collaborator NETWORK

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • International Rare Cancers Initiative (IRCI ) This study is indorsed by IRCI

    collaborator UNKNOWN

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Sheela Rao, MD, FRCP · Royal Marsden NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-08-31
Completion
2018-02-28

Countries

  • United States
  • Australia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02051868 on ClinicalTrials.gov