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Concomitant radiochemotherapy with Tegafur and Mitomycin in locally advanced anal canal cancer: Dose Escalation Study. - ND

Concomitant radiochemotherapy with Tegafur and Mitomycin in locally advanced anal canal cancer: Dose Escalation Study. - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-003767-39-IT
Enrollment
Unknown
Registered
2009-05-25
Start date
2008-09-14
Completion date
Unknown
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

locally advanced squamous anal canal cancer MedDRA version: 9.1 Level: LLT Classification code 10041840 Term: Squamous cell carcinoma of the anus stage unspecified

Interventions

Trade Name: UFT*42CPS 100MG+224MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: TEGAFUR CAS Number: 17902-23-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration num

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: histologic diagnosis of squamous anal canal carcinoma; >=T2 and/or N+, M0; HIV -; ECOG 0-1; normal hepatic and renal parameters;informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: previous radiotherapy on pelvis, previous chemotherapy; previous local surgical excisions;pregnancy

Design outcomes

Primary

MeasureTime frame
Main Objective: To define the Maximux Tolerated Dose (MTD) of Tegafur in association with Mitomycin and radiotherapy in the treatment of locally advanced anal canal cancer.;Secondary Objective: to evaluate the clinical response; to evaluate the local control.;Primary end point(s): n.d.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026