Trial of TP Versus TC Regimens for Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)
Uterine Cervical Neoplasms
About this trial
This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring cervical cancer, palliative chemotherapy, recurrent, persistent, stageⅣb, cisplatin, carboplatin, paclitaxel
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Aichi Cancer Center Hospital
- Nagoya Medical Center
- National Hospital Organization Shikoku Cancer Center
- Kyushu University Hospital
- National Kyushu Cancer Center
- Kurume University School of Medicine
- Gunma Prefectural Cancer Center
- National Hospital Organization Kure Medical Center Chugoku Cancer Center
- Hokkaido University Hospital
- Sapporo Medical University
- Hyogo Medical Center for Adults
- Institute of Clinical Medicine,Tsukuba University Hospital
- Kagoshima City Hospital
- Tohoku University Hospital
- Sinshu University
- Nagaoka Red Cross Hospital
- Niigata Cancer Center Hospital
- Osaka Medical Center for Cancer and Cardiovascular Diseases
- Osaka City General Hospital
- Kinki University School of Medicine
- Faculty of Medicine, Saga University
- Saitama Medical Center, Saitama Medical School
- Saitama Cancer Center
- National Defense Medical College
- Juntendo University School of Medicine
- The University of Tokyo Hospital
- National Cancer Center Hospital
- Cancer Institute Hospital
- Jikei University Hospital
- Tottori University School of Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
1
2
Drug: chemotherapy: Paclitaxel/Cisplatin
Drug: chemotherapy: Paclitaxel/Carboplatin