A PROSPECTIVE PHASE II MULTICENTRIC STUDY OF WEEKLY TOPOTECAN AND CISPLATIN (TOPOCIS) AS NEOADJUVANT TREATMENT IN PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CERVICAL CANCER - TOPOCIS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005176-28-IT

Enrollment

Registered

2009-09-10

Start date

2008-11-07

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Locally advanced cervical carcinoma

Interventions

Trade Name: HYCAMTIN Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Topotecan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Trade Name: CISPLA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -histologically documented locally advanced cervix squamous cell carcinoma -stages IB2, IIA and IIB; -18 to 70 years; -ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Pregnant or lactating patients; -high surgical risk (ASA 4-5); -one or more lines of chemotherapy including (neo)adjuvant or palliative; -prior radiotherapy; -recurrent metastatic disease; -presence of active infection other serious medical condition precluding treatment; -concurrent nor past neoplasm; -concomitant administration of any other experimental drug under investigation; -concurrent treatment with any other anti-cancer therapy; growth factors with preventive intent. -Abnormal hematological, renal, cardiovascular or hepatic functions.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary endpoint is the clinical response rate of a neoadjuvant treatment with weekly topotecan and cisplatin in cervical cancer locally advanced.;Secondary Objective: Secondary endpoints are the rate of optimal pathological responses, the progression free survival, the overall survival, the clinical safety and laboratory determinations.;Primary end point(s): Clinical tumor response	—

Measure

Time frame

Main Objective: The primary endpoint is the clinical response rate of a neoadjuvant treatment with weekly topotecan and cisplatin in cervical cancer locally advanced.;Secondary Objective: Secondary endpoints are the rate of optimal pathological responses, the progression free survival, the overall survival, the clinical safety and laboratory determinations.;Primary end point(s): Clinical tumor response

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Countries

Italy

Outcome results

None listed

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