Postoperative uterine cervical cancer patients with high-risk prognostic factors
Conditions
Interventions
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.
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion 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 or chemotherapy for other malignancies 11. Adequate organ functions 12. Written informed consent
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year relapse free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, locoregional-relapse free survival, proportion of >= Grade 3 lower gastrointestinal complication, proportion of lower limb edema, adverse events, serious adverse events | — |
Countries
Japan
Contacts
Public ContactFumiaki Isohashi
JCOG1402 Coordinating Office Osaka University Graduate School of Medicine
Outcome results
None listed