CCRT for VSCC

Phase 2

• Conditions: Squamous cell carcinoma of vulva

• Registration Number: JPRN-jRCTs021180042
• Lead Sponsor: Futagami Masayuki

Brief Summary

The antitumor effect, which is the primary endpoint, is extremely high, and the tumor control rate is higher than that of the conventional method. The 2-year survival rate is 57.1% even in stages III and IV, but long-term follow-up has not been performed, so this is for further study. Regarding safety, there were few serious adverse events and it was highly possible that it could be done safely.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-26
• Study Completion: 2021-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

1) Patients with a histiological diagnosis of squamous cell carcinoma of vulva
2) Patients with measurable or evaluable lesions
3) First treatment case
4) Age is from 20 to 79 years old
5) ECOG Performance Status is 0-2
6) Major organ function is maintained
7) Patients who signed informed consent

Exclusion Criteria

1) Patients who have received prior chemotherapy or/and
irradiation therapy
2) Patients with active synchronous cancer
3) Patients with active infection
4) Patients with severe complication, bronchial asthma, interstitial pneumonia, ischemic heart disease, diabetic mellitus and arrhythmia
5) Patients with massive pleural effusion or asites
6) Patients with history of hypersensitivity reaction
7) Patients with pregnant or lactating
8) Patients who is difficult to treat and follow in this study
9) Patients who are not eligible in this study by study chair or study co-chair.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response of tumor

Secondary Outcome Measures

Name	Time	Method
Progression free survival, Overall survival