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Anti-metabolites

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

Phase 2
Waitlist Available
Led By Sheela Rao, MD, FRCP
Research Sponsored by Royal Marsden NHS Foundation Trust
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

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.

Eligible Conditions
  • Anal Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Best overall response rate by 24 weeks post treatment
Secondary study objectives
Anti-tumour activity and magnitude of tumour response
Best overall response rate of non-irradiated lesions
Disease control rate
+6 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm BExperimental Treatment2 Interventions
Carboplatin plus Paclitaxel
Group II: Arm AActive Control2 Interventions
Cisplatin and 5-Fluorouracil
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

Royal Marsden NHS Foundation TrustLead Sponsor
328 Previous Clinical Trials
10,151,750 Total Patients Enrolled
Cancer Research UKOTHER
260 Previous Clinical Trials
4,435,194 Total Patients Enrolled
Australasian Gastro-Intestinal Trials GroupNETWORK
25 Previous Clinical Trials
7,883 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupNETWORK
121 Previous Clinical Trials
180,117 Total Patients Enrolled
European Organisation for Research and Treatment of Cancer - EORTCNETWORK
414 Previous Clinical Trials
165,530 Total Patients Enrolled
International Rare Cancers Initiative (IRCI ) This study is indorsed by IRCIUNKNOWN
Sheela Rao, MD, FRCPPrincipal InvestigatorRoyal Marsden NHS Foundation Trust
~7 spots leftby Jan 2026
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