CCRT for VSCC

JRCT ID: jRCTs021180042

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Squamous cell carcinoma of vulva
• Date of first enrollment: 26/11/2014
• Target sample size: 40
• Study type: Interventional
• Intervention(s): 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 pelvic area. The dose of RT for microscopic disease was 45 Gy and for gross disease was 65 Gy with conventional fractionation; 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 the inguinal node region. For CCRT, 30 mg/m2 nedaplatin was administered weekly during RT. Six cycle of nedaplatin is performed.

Outcome(s)

• Primary Outcome: Response of tumor
• Secondary Outcome: Progression free survival, Overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Female

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Futagami Masayuki