Multi-institutional retrospective observational study of definitive radiotherapy/chemoradiotherapy in cervical cancer

JRCT ID: jRCT1072210070

Registered date:30/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Uterine cervical cancer
• Date of first enrollment: 15/09/2021
• Target sample size: 150
• Study type: Observational

Outcome(s)

• Primary Outcome: 2-year local progression-free survival
• Secondary Outcome: 2-year distant metastases-free survival, 2-year progression-free survival, 2-year overall survival, 2-year incidence of late complications (rectum, bladder, sigmoid colon, small bowel, others)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Female

Include criteria

For inclusion in the study, patient should fulfill the following criteria:
1.Pathologically diagnosed intact uterine cervical cancer
2.FIGO 2018 stages of IB1-3, IIA1-2, IIB, IIIA, IIIB, IIIC1-2, IVA
3.ECOG performance status of 0-3
4.Aged at 18 to 85 years
5.Diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
6.Undergone definitive radiotherapy/chemoradiotherapy consisting of external beam radiotherapy (3DCRT/IMRT) without central shielding and 3D-image guided brachytherapy between January 2014 and June 2020
7.No prior chemotherapy (NAC) or surgery for cervical cancer
8.No history of surgery for other pelvic malignancies

Exclude criteria

Patients should not enter the study if any of the following exclusion criteria are fulfilled:
1.History of another malignancy within 5 years
2.Inadequate medical information
3.Refusal from patients or representatives

Related Information

• Primary Sponsor: Toita Takafumi