Trial of TP Versus TC Regimens for Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)
A Randomized Phase III Trial of Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Carboplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)
2 other identifiers
interventional
253
1 country
30
Brief Summary
To evaluate the clinical benefits of Paclitaxel plus Carboplatin compared with Paclitaxel plus Cisplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2006
Longer than P75 for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 23, 2006
CompletedFirst Posted
Study publicly available on registry
February 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedSeptember 22, 2016
September 1, 2016
5.8 years
February 23, 2006
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
During the study conduct
Secondary Outcomes (5)
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
Study Arms (2)
1
ACTIVE COMPARATORDrug: chemotherapy: Paclitaxel/Cisplatin
2
EXPERIMENTALDrug: chemotherapy: Paclitaxel/Carboplatin
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haruhiko Fukudalead
- Ministry of Health, Labour and Welfare, Japancollaborator
Study Sites (30)
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681, Japan
Nagoya Medical Center
Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi-ken, 460-0001, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, 790-0007, Japan
Kyushu University Hospital
Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, 812-8582, Japan
National Kyushu Cancer Center
Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, 811-1395, Japan
Kurume University School of Medicine
Kurume, Asahi-machi, 67, Fukuoka, 830-0011, Japan
Gunma Prefectural Cancer Center
Ota,Takabayashi-nishi-cho,617-1, Gunma, 373-8550, Japan
National Hospital Organization Kure Medical Center Chugoku Cancer Center
Kure,Aoyama-cho,3-1, Hiroshima, 737-0023, Japan
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, 060-8648, Japan
Sapporo Medical University
S-1,W-16,Chuo-ku,Sapporo, Hokkaido, 060-8543, Japan
Hyogo Medical Center for Adults
Akashi,Kitaouji-cho,13-70, Hyōgo, 673-8558, Japan
Institute of Clinical Medicine,Tsukuba University Hospital
Tsukuba,Tennodai,1-1-1, Ibaraki, 305-8575, Japan
Kagoshima City Hospital
Kagoshima,Kajiya-cho,20-17, Kagoshima-ken, 892-8580, Japan
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, 980-8574, Japan
Sinshu University
Matsumoto,Asahi,3-1-1, Nagano, 390-8621, Japan
Nagaoka Red Cross Hospital
Nagaoka,Terashima-cho,297-1, Niigata, 940-2085, Japan
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511, Japan
Osaka City General Hospital
Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, 534-0021, Japan
Kinki University School of Medicine
Osaka-Sayama,Ohno-higashi,377-2, Osaka, 589-8511, Japan
Faculty of Medicine, Saga University
Saga,Nabeshima,5-1-1, Saga-ken, 849-8501, Japan
Saitama Medical Center, Saitama Medical School
Kawagoe,Komoda,1981, Saitama, 350-8550, Japan
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, 362-0806, Japan
National Defense Medical College
Tokorozawa,Namiki,3-2, Saitama, 359-8513, Japan
Juntendo University School of Medicine
Bunkyo-ku,Hongo,3-1-3, Tokyo, 113-0033, Japan
The University of Tokyo Hospital
Bunkyo-ku,Hongo,7-3-1, Tokyo, 113-8655, Japan
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045, Japan
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, 135-8550, Japan
Jikei University Hospital
Minato-ku,Nishishinbashi,3-25-8, Tokyo, 105-8461, Japan
Tottori University School of Medicine
Yonago,Nishimachi,36-1, Tottori, 683-8504, Japan
Related Publications (1)
Kitagawa R, Katsumata N, Shibata T, Kamura T, Kasamatsu T, Nakanishi T, Nishimura S, Ushijima K, Takano M, Satoh T, Yoshikawa H. Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Cisplatin in Metastatic or Recurrent Cervical Cancer: The Open-Label Randomized Phase III Trial JCOG0505. J Clin Oncol. 2015 Jul 1;33(19):2129-35. doi: 10.1200/JCO.2014.58.4391. Epub 2015 Mar 2.
PMID: 25732161DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Toshiharu Kamura, MD, PhD
Kurume University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- JCOG Data Center
Study Record Dates
First Submitted
February 23, 2006
First Posted
February 24, 2006
Study Start
February 1, 2006
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
September 22, 2016
Record last verified: 2016-09