Status:
COMPLETED
Trial of TP Versus TC Regimens for Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)
Lead Sponsor:
Haruhiko Fukuda
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Uterine Cervical Neoplasms
Eligibility:
FEMALE
20-75 years
Phase:
PHASE3
Brief Summary
To evaluate the clinical benefits of Paclitaxel plus Carboplatin compared with Paclitaxel plus Cisplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer
Detailed Description
Prognosis of the advanced, recurrent, or persistent cervical cancer, which is not amenable to curative treatment with surgery and/or radiation therapy, still remains poor. Recently, cisplatin plus pac...
Eligibility Criteria
Inclusion
- histologically proven uterine cervical cancer
- squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix
- one of the followings, 1)primary stage Ⅳb cervical cancer, 2)the first relapse or persistent cervical cancer after curative first line treatments, 3)the second relapse or persistent cervical cancer after curative second line treatments including radiation, systemic chemotherapy, hormonal therapy, or vaccination therapy for the first relapse
- Patients may have been previously treated with less than 50 Gy of palliative radiation therapy
- Patients have received no prior treatment or a certain interval must have elapsed from the last administration of previous treatments including palliative radiation therapy
- one of the followings, 1)There is at least one metastatic lesion outside the pelvic cavity except paraaortic LN and/or inguinal LN, 2)There is no metastatic lesion outside the pelvic cavity except paraaortic LN and/or inguinal LN and some of the lesions have been irradiated, 3)All lesions are localized inside the pelvic cavity, and some of them have been irradiated
- no prior surgical therapy for metastatic lesions of the lung or inside the pelvic cavity
- no bilateral hydronephrosis
- no prior chemotherapy including more than two platinum-containing regimens
- no prior chemotherapy including taxane
- age: 20 to75 years
- PS: 0-2
- ANC ≧1,500 /mm3, Plt≧10.0×104/mm3, T-bil≦1.5 mg/dl, GOT（AST）≦100IU/l, sCre ≦1.2 mg/dl, Ccr≧50ml/min in using the Cockcroft-Gault equation, and normal ECG
- written informed consent
Exclusion
- patients who have some neurologically functional disorder
- symptomatic CNS metastasis
- hypersensitive to alcohol
- active infection
- HBs antigen positive
- uncontrollable hypertension
- history of myocardiac infarction within six months
- unstable angina
- uncontrollable diabetes
- Patients with a concomitant or prior invasive malignancy (except intramucosal malignancy which are curable with local therapy) who have had any evidence of the disease within the last 5 years
- women during pregnancy or breast-feeding
- patients with psychiatric illness
- patients who have been treated with the systemic steroids medication
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT00295789
Start Date
February 1 2006
End Date
November 1 2011
Last Update
September 22 2016
Active Locations (30)
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1
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan, 464-8681
2
Nagoya Medical Center
Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi-ken, Japan, 460-0001
3
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
4
Kyushu University Hospital
Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan, 812-8582