Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062361) titled 'A Prospective Observational Study of Advanced Radiation Therapy for Locally Advanced Cervical Cancer in FNCA Member Countries' on Aug. 15.
Study Type:
Observational
Primary Sponsor:
Institute - Gunma University
Condition:
Condition - Uterine cervical cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To determine the safety and efficacy of combination of intensity-modulated radiotherapy (IMRT) and 3D-image-guided brachytherapy (3D-IGBT) for patients with locally advanced cervical cancer in FNCA countries.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Female
Key inclusion criteria - 1. Squamous cell carcinoma of the uterine cervix
2. FIGO 2018 stage IIB-IIIC1r, excluding stage IIIA
3. Age: 20-70 years
4. WHO performance status (PS): 0-2
5. No prior chemotherapy, pelvic radiotherapy, or pelvic surgery
6. Life expectancy >=6 months
7. Adequate bone marrow, hepatic, and renal function:
- WBC >=3000/uL
- Hb >=9 g/dL
- Platelet count >=100000/mm3
- Total bilirubin 1 cm)
11. Not pregnant or breastfeeding
Key exclusion criteria - 1. Presence of severe concomitant illness
2. History of other malignancies within the past 5 years except basal cell carcinoma or squamous cell carcinoma in-situ of the skin
3. Tumor involving the lower 1/3 of the vagina (IIIA disease)
Target Size - 160
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 06 Month 09 Day
Date of IRB - 2026 Year 06 Month 09 Day
Anticipated trial start date - 2026 Year 06 Month 09 Day
Last follow-up date - 2031 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071306
Disclaimer: Curated by HT Syndication.
