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CCRT for VSCC

The effectiveness and safety of cocurrent chemoradiation therapy for squamous cell carcinoma of vulva; P2 Study - CCRT for VSCC

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs021180042
Enrollment
40
Registered
2019-03-26
Start date
2014-11-26
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

Squamous cell carcinoma of vulva

Interventions

RT was performed according to the RT guidelines of the Japanese Society for Radiation Oncology
JASTRO. The target margins were consisted as follows: clinical target volume
CTV was gross tumor volume
GTV plus 2 cm margin in all directions
planning target volume
PTV was CTV plus 0.5 cm margin in all directions. A leaf margin was also taken 0.5 cm around the PTV. For cases with inguinal lymph node metastasis, the radiation field was expanded to the whole pelvi
1.2 to 2.0 Gy per fraction, 5 days a week. RT consisted of external beam radiation using AP PA opposed beams generated by a linear acceler- ator with 6 to 18 MV X ray. Electrons were used for boosting

Sponsors

Futagami Masayuki
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Response of tumor

Secondary

MeasureTime frame
Progression free survival, Overall survival

Contacts

Public ContactMasayuki Fuatgami

Hirosaki University Hospital

futagami@hirosaki-u.ac.jp+81-172-39-5107

Outcome results

None listed

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