Tokyo, July 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062139) titled 'Clinical trial of ultra-hypofractionated small pelvic irradiation for cervical cancer using online adaptive radiotherapy with MR linac' on July 4.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Tohoku University
Condition:
Condition - Cervical cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the safety and efficacy of ultra-hypofractionated small pelvic irradiation for cervical cancer using online adaptive radiotherapy with MR linac.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Small pelvic irradiation with 30 Gy in 5 fractions using MR linac (twice a week).
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - (1) Cervical cancer stage IB1-2, stage IIA1 (FIGO2018) without corpus invasion, for which curative radiation therapy is planned, or cases with a moderate risk of postoperative recurrence (for cases without lymph node dissection, the preoperative tumor diameter must be less than 4 cm).
(2) Histologically proven squamous cell carcinoma.
(3) 20 years or older (at registration).
(4) ECOG PS of 0-2
(5) No prior history of radiation therapy to the abdomen or pelvis.
(6) Adequate organ functions
(7) Written informed consent
Key exclusion criteria - (1) Patients with severe complications (heart failure, renal failure, hepatic failure, respiratory dysfunction, lymphatic obstruction, poorly controlled diabetes, etc.).
(2) Patients with metal implants that are not compatible with MRI.
(3) Patients who have difficulty maintaining a supine position due to claustrophobia, etc.
(4) An infectious disease (excluding viral hepatitis) that requires systemic treatment
(5) Other active malignancy at the start of our study
(6) Patients requiring systemic steroids medication or other immunosuppressants
(7) Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
(8) Patients with severe psychological disorder
(9) Other cases that were judged to be inappropriate for conducting this study
Target Size - 25
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 07 Day
Anticipated trial start date - 2026 Year 08 Month 01 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=R000070352
Disclaimer: Curated by HT Syndication.
