Uterine cervical carcinoma
Conditions
Interventions
Patients receive radiotherapy and intravenous administration of cispaltin and paclitaxel once a week, simultaneously. Traetment repeats weekly for 5 to 7 courses in the absence of unacceptable toxicit
Sponsors
Japanese Cancer Clinical Research Organization(JACCRO)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patient whose primary lesion is histologically diagnosed as cervical cancer. 2) Patient whose performance status (PS) is 0 or 1. 3) Patient whose age is over 20 and below 70 at the time of registration. 4) Patient whose clinical stage is IIIa, IIIb and IVa and who has no enlargement of para-aortic lymph node over 10mm with CT within four weeks before registration. 5) Patient who has no pretreatment history of radiotherapy, chemical therapy and operation for cervical cancer. 6) Patient who preserves function of main organs. 7) Patient whose written consent for participation in this test has been obtained in person.
Exclusion criteria
Exclusion criteria: 1) Patient with stump cancer 2) Patient who has an active infection. 3) Patient who has a hydronephrosis. 4) Patient who has myocardial infarction, unstable angina and uncontrolled irregular heartbeat within six months before registration. 5) Patient who has a serious complication. 6) Patient who has a radiotherapy history in the pelvic region. 7) Patient who has an active double cancer. However, cancers in situ that are considered as recovered by local treatment or legions equivalent to intramucosal cancer are not included in the active double cancers. 8) Patient who underwent exploratory laparotomy for cervical cancer. 9) Patient who is complicated by mental disease or psychological symptom and considered difficult to participate in the test. 10) Patient who is pregnant or of child-bearing potential or breast-feeding. 11) Patient who is diagnosed as a pyometra and there is no improvement in pyometra and infection despite the implementation of appropriate measures. 12) Other cases where doctors in attendance consider patients inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom-from-progression at two years | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Therapy completion rate (2) Onset rate of adverse event by grade (3) Complete response rate (4) Two-year survival rate (5) Two-year progression-free rate in the pelvis (6) Two-year incidence of distant metastasis | — |
Countries
Japan
Contacts
Public ContactKenji Umayahara
Cancer Institute Hospital Gynecology
Outcome results
None listed