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

PHASE2UnknownINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

August 31, 2017

Study Completion Date

February 28, 2018

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.

Trial Locations (3)

MA 02215

NOT_YET_RECRUITING

Laura Gagnon, Boston

NSW 1450

NOT_YET_RECRUITING

Margot Gorzeman, Sydney

SM2 5PT

RECRUITING

Royal Marsden NHS Foundation Trust, London & Sutton, Sutton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cancer Research UK

OTHER

collaborator

Australasian Gastro-Intestinal Trials Group

NETWORK

collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

collaborator

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

UNKNOWN

lead

Royal Marsden NHS Foundation Trust

OTHER