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

JRCT ID: jRCTs031180194

Registered date:06/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Postoperative uterine cervical cancer patients with high-risk prognostic factors
• Date of first enrollment: 27/06/2017
• Target sample size: 220
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: 3-year relapse free survival
• Secondary Outcome: Overall 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
• Gender: Female

Include criteria

1. 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 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 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

• Primary Sponsor: Toita Takafumi
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000027017