JCOG1101: Nonrandomized confirmatory trial of modified radical hysterectomy for patients with FIGO stage Ib1 (< 2 cm) uterine cervical cancer

Phase 3

• Conditions: Tumor diameter 2cm or less FIGO stage Ib1 uterine cervical cancer

• Registration Number: JPRN-jRCTs031180167
• Lead Sponsor: KOBAYASHI Hiroaki

Brief Summary

Modified radical hysterectomy (MRH) was as effective as radical hysterectomy and less invasive. MRH can be considered a standard surgery for tumor diameter <= 2 cm Stage IB1 uterine cervical cancer.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-01
• Study Completion: 2022-12-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1) Any one of the following histology in primary lesion located at uterine cervix.
i) Squamous cell carcinoma (keratinizing or nonkeratinizing type)
ii) Adenosquamous carcinoma (except for glassy cell carcinoma)
iii) Adenocarcinoma (endocervical type mucinous adenocarcinoma, intestinal type mucinous adenocarcinoma, or endometrioid adenocarcinoma)
2) To fulfill i) or ii) in clinical stage IB1 (The General Rules for Clinical and Pathological Management of Uterine Cervical Cancer, the 3rd edition, 2012)
i) When tumor is detected in pelvic MRI within 56 days before registration and its maximum diameter is 2cm or less, (a) or (b) are fulfilled
(a) In case with diagnostic conization of the cervix within 49 days before registration, the maximum length of invasive tumor is 2 cm or less with the diagnostic conization
(b) In case without diagnostic conization of the cervix, invasive tumor is not detected or length of invasive tumor is 2 cm or less in colposcopy within 56 days before registration
ii) When tumor is not detected in pelvic MRI within 56 days before registration, (a) or (b) are fulfilled
(a) When invasive tumor is not detected in colposcopy within 56 days before registration, the maximum length of invasive tumor is 2 cm or less with diagnostic conization of the cervix within 49 days before registration
(b) Invasive tumor is detected and the maximum length of the tumor is 2 cm or less in colposcopy within 56 days before registration
3) Neither distant lymph node metastasis nor distant metastasis in abdominal and pelvic computed tomography within 56 days before registration
4) Aged 20 to 70 years old
5) ECOG performance status (PS) of 0 or 1
6) No following prior treatment
i) Surgery except for cervical conization for uterine cervical cancer
ii) Surgery for lower abdominal or pelvic malignancy
iii) Radiation therapy or chemotherapy for other malignancies
7) Adequate organ functions
8) Written informed consent

Exclusion Criteria

1) Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor.
2) Active systemic infections to be treated.
3) Body temperature of 38 or more degrees Celsius
4) Women during pregnancy, possible pregnancy, or breast-feeding
5) Psychiatric disease
6) Continuous systemic steroid treatment
7) Uncontrolled diabetes mellitus or routine administration of insulin
8) Uncontrolled hypertension

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5-year overall survival

Secondary Outcome Measures

Name	Time	Method
Overall survival, relapse-free survival, local relapse-free survival, completion rate of modified radical hysterectomy, local relapse rate, pathological parametrial involvement rate, days until self urination and residual urine disappearance, bleeding volume, operation time, rate of postoperative radiation therapy or concurrent chemoradiotherapy, adverse events, severe adverse events