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SPARTANA : Spartalizumab, mDCF (docetaxel, cisplatin and 5-fluorouracil) and radiotherapy in patients with metastatic squamous cell anal carcinoma. A Phase IIA study

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516005-23-00
Enrollment
34
Registered
2024-08-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-22

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

Conditions

metastatic squamous cell anal carcinoma

Brief summary

The primary endpoint is the Progression Free Survival (PFS) rate at 1 year evaluated by RECIST criteria v1.1. PFS rate at 1 year is defined as the number of patients alive without progression at 1 year divided by the overall number of patients evaluable for PFS status at 1 year.

Interventions

DRUGDOCETAXEL
DRUGPDR001
DRUGCISPLATIN
DRUGMITOMYCIN
DRUGFLUOROURACIL

Sponsors

Centre Hospitalier Regional Universitaire
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the Progression Free Survival (PFS) rate at 1 year evaluated by RECIST criteria v1.1. PFS rate at 1 year is defined as the number of patients alive without progression at 1 year divided by the overall number of patients evaluable for PFS status at 1 year.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026