Trial of TP Versus TC Regimens for Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)
- Conditions
- Uterine Cervical Neoplasms
- Registration Number
- NCT00295789
- Lead Sponsor
- Haruhiko Fukuda
- 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 paclitaxel for palliative chemotherapy were reported to improve the response rate and progression-free interval compared to cisplatin alone and has been shown as a new appropriate regimen. However, more effective and/or less toxic combinations are needed. Carboplatin as a single agent has less response rate but less overall toxicity than cisplatin. Particularly, because less nephrotoxicity does not require hydration and less neurotoxicity enables 3hrs administration of paclitaxel in the combination, out patient therapy becomes possible and patients' quality of life must improve. Therefore, we planned to evaluate the benefits of less toxicity of the chemotherapy containing paclitaxel and carboplatin, which could reduce the hospitalised days, in comparison with the standard chemotherapy containing paclitaxel and cisplatin. This clinical trial is targeted on the patients in Japan with incurable cervical cancer diagnosed by means of image.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 253
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method overall survival During the study conduct
- Secondary Outcome Measures
Name Time Method progression-free survival During the study conduct response rate During the study conduct adverse events During the study conduct severe adverse events During the study conduct proportion of periods of non-hospitalization to those of the planned treatment 18 weeks
Trial Locations
- Locations (30)
Nagoya Medical Center
🇯🇵Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi, Japan
Faculty of Medicine, Saga University
🇯🇵Saga,Nabeshima,5-1-1, Saga, Japan
Aichi Cancer Center Hospital
🇯🇵Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama,Horinouchi,13, Ehime, Japan
Kyushu University Hospital
🇯🇵Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan
National Kyushu Cancer Center
🇯🇵Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan
Gunma Prefectural Cancer Center
🇯🇵Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan
Kurume University School of Medicine
🇯🇵Kurume, Asahi-machi, 67, Fukuoka, Japan
National Hospital Organization Kure Medical Center Chugoku Cancer Center
🇯🇵Kure,Aoyama-cho,3-1, Hiroshima, Japan
Hokkaido University Hospital
🇯🇵North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan
Institute of Clinical Medicine,Tsukuba University Hospital
🇯🇵Tsukuba,Tennodai,1-1-1, Ibaraki, Japan
Sapporo Medical University
🇯🇵S-1,W-16,Chuo-ku,Sapporo, Hokkaido, Japan
Hyogo Medical Center for Adults
🇯🇵Akashi,Kitaouji-cho,13-70, Hyogo, Japan
Kagoshima City Hospital
🇯🇵Kagoshima,Kajiya-cho,20-17, Kagoshima, Japan
Nagaoka Red Cross Hospital
🇯🇵Nagaoka,Terashima-cho,297-1, Niigata, Japan
Tohoku University Hospital
🇯🇵Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan
Sinshu University
🇯🇵Matsumoto,Asahi,3-1-1, Nagano, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
🇯🇵Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan
Osaka City General Hospital
🇯🇵Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan
Kinki University School of Medicine
🇯🇵Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan
Saitama Cancer Center
🇯🇵Kita-adachi,Ina,Komuro,818, Saitama, Japan
Saitama Medical Center, Saitama Medical School
🇯🇵Kawagoe,Komoda,1981, Saitama, Japan
National Defense Medical College
🇯🇵Tokorozawa,Namiki,3-2, Saitama, Japan
The University of Tokyo Hospital
🇯🇵Bunkyo-ku,Hongo,7-3-1, Tokyo, Japan
Tottori University School of Medicine
🇯🇵Yonago,Nishimachi,36-1, Tottori, Japan
Jikei University Hospital
🇯🇵Minato-ku,Nishishinbashi,3-25-8, Tokyo, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata,Kawagishi-cho,2-15-3, Niigata, Japan
Cancer Institute Hospital
🇯🇵Koto-ku,Ariake,3-10-6, Tokyo, Japan
Juntendo University School of Medicine
🇯🇵Bunkyo-ku,Hongo,3-1-3, Tokyo, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan