NIPH Clinical Trials Search

JRCT ID: jRCTs031180194

Registered date:06/03/2019

JCOG1402: Non-randimized confirmatory trial of postoperative concurrent chemoradiotherapy (CCRT) using IMRT for patients with high-risk uterine cervical cancer

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedPostoperative uterine cervical cancer patients with high-risk prognostic factors
Date of first enrollment27/06/2017
Target sample size220
Countries of recruitment
Study typeInterventional
Intervention(s)Cisplatin (40 mg/m2) is administered intravenously on a weekly basis for 5 weeks during the course of IMRT. The IMRT dose is 50.4 Gy/28 fr.


Primary Outcome3-year relapse free survival
Secondary OutcomeOverall survival, locoregional-relapse free survival, proportion of >= Grade 3 lower gastrointestinal complication, proportion of lower limb edema, adverse events, serious adverse events

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 70age old
Include criteria1. Clinical stage IB1, IB2, IIA1, IIA2, IIB cervical cancer (FIGO 2008) 2. Histological findings of squamous cell carcinoma (keratinizing or non-keratinizing), adenocarcinoma (endocervical mucinous type, intestinal mucinous type or endometrial type), or adenosquamous carcinoma 3. Histologically confirmed positive pelvic lymph nodes and/or parametrial invasion. 4. No distant metastasis in chest to pelvic contrast enhanced CT within 56 days before surgery 5. In case with node dissection except pelvic lesion, there is no positive node in these lesions. 6. Radical hysterectomy is performed and the following (i) to (v) are fulfilled. i) R0 resection ii) Negative margin is confirmed by pathological findings. iii) At least 20 lymph nodes dissection confirmed by pathological findings. iv) Ligamentum cardinale is removed. v) The cut length of paracolpium and vagina is 2cm or more. 7. Aged 20 to 70 years old 8. ECOG performance status of 0 or 1 9. Within 28 to 56 days after surgery 10. No following prior treatment i) Surgery except for cervical conization or radical hysterectomy for uterine cervical cancer ii) Surgery for lower abdominal or pelvic malignancy iii)Radiation therapy to the pelvis or chemotherapy for other malignancies 11. Adequate organ functions 12. Written informed consent
Exclude criteria1) 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 or possible pregnancy, within 28 days after delivery, or during breast-feeding 5) Severe psychiatric disease 6) Continuous systemic steroid treatment 7) Insulin-dependent or uncontrolled diabetes mellitus 8) Uncontrolled hypertension 9) Unstable angina, or history of myocardial infarction within 6 months 10) HBs antigen or HCV antibody positive 11) HIV antibody positive 12) Interstitial pneumonitis, lung fibrosis or severe emphysema on chest CT

Related Information


Public contact
Name Higa Miwako
Address Miyazato 281, Uruma, Okinawa, Japan Okinawa Japan 904-2293
Telephone +81-98-973-4111
Affiliation Okinawa Chubu Hospital
Scientific contact
Name Takafumi Toita
Address Miyazato 281, Uruma, Okinawa, Japan Okinawa Japan 904-2293
Telephone +81-98-973-4111
Affiliation Okinawa Chubu Hospital