NIPH Clinical Trials Search

Study on prediction of recurrence after chemoradiotherapy for cervical cacner

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Uterine cervical cancer
Date of first enrollment	24/03/2025
Target sample size	120
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

AUC of ROC analysis with the predicted value of the occurrence of out-of-field recurrence calculated by the multi-radiomic model as the independent variable and out-of-field recurrence as the dependent variable.

Secondary Outcome

Sensitivity and specificity at the cutoff value that gives a positive predictive value of 0.9 for the predictive value of the occurrence of out-of-field recurrence calculated by the multi-radiomic model. AUC of ROC analysis with the predicted value of local recurrence/progression calculated by the multi-radiomic model as the independent variable and recurrence/progression as the dependent variable Overall survival Progression-free survival

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Female
Include criteria	The patient is 18 years or older at the time of the initial visit. Cervical cancer is diagnosed histopathologically and the histological type is either squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Patients diagnosed as stage IIB or stage III or stage IVA (JSOG 2020, FIGO 2018). Patients who are scheduled to start radical chemoradiotherapy between the date of approval by the Ethics Committee of Tokushima University Hospital and the date of permission by the head of the affiliated institution. Concurrent chemotherapy must be a platinum-containing regimen. Patients undergoing pelvic MRI T2-weighted image and diffusion weighted image within 1 month prior to the start of radiotherapy. Patients to be followed up for 2 years after completion of chemoradiotherapy.
Exclude criteria	Patients undergoing neoadjuvant chemotherapy prior to radiation therapy. Patients undergoing particle beam therapy as external-beam radiation therapy. Patients who receive prophylactic extended-field irradiation (prophylactic para-aortic lymph node irradiation) as external-beam radiotherapy. However, extended-field irradiation in stage IIIC2 does not meet this exclusion criterion.