Phase II study of weekly Vinorelbine and Topotecan administration treatment for refractory adult rhabdomyosarcoma previously treated by VAC regimen.

Phase II study of weekly Vinorelbine and Topotecan administration treatment for refractory adult rhabdomyosarcoma previously treated by VAC regimen. - V-TOP trial

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005132

Enrollment

Registered

2011-04-01

Start date

2011-06-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

refractory adult rhabdomyosarcoma previously treated by VAC regimen.

Interventions

Topotecan, Vinorelbine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age => 20 2. PS 0-2 3. ECG clinically not significant 4. No clinical signs of ileus, huge ascites 5. Normal bone marrow functions 6. Normal organ function by blood test 7. NO previous treatment of irinotecan, topotecan, and vinorelbine 8. Informed consent available

Exclusion criteria

Exclusion criteria: 1. No pregnant 2. No active infections 3. No interstitial pneumonia by X-ray 4. No symptom of brain metastais 5. No HIV positive 6. No grade 3 peripherasl neuropathy

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Adverse event Progression-free survival Overall survival	—

Countries

Japan

Contacts

Public ContactKenji Hashimoto

National Cancer Research Center Hospital Breast and Medical Oncology Division

kehashim@ncc.go.jp03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026