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Trial of TP Versus TC Regimens for Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)

Primary Purpose

Uterine Cervical Neoplasms

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
chemotherapy: Paclitaxel/Cisplatin
chemotherapy: Paclitaxel/Carboplatin
Sponsored by
Haruhiko Fukuda
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Drug: chemotherapy: Paclitaxel/Cisplatin

Drug: chemotherapy: Paclitaxel/Carboplatin

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

progression-free survival
response rate
adverse events
severe adverse events
proportion of periods of non-hospitalization to those of the planned treatment

Full Information

First Posted
February 23, 2006
Last Updated
September 20, 2016
Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00295789
Brief Title
Trial of TP Versus TC Regimens for Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms
Keywords
cervical cancer, palliative chemotherapy, recurrent, persistent, stageⅣb, cisplatin, carboplatin, paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Drug: chemotherapy: Paclitaxel/Cisplatin
Arm Title
2
Arm Type
Experimental
Arm Description
Drug: chemotherapy: Paclitaxel/Carboplatin
Intervention Type
Drug
Intervention Name(s)
chemotherapy: Paclitaxel/Cisplatin
Intervention Description
Drug: chemotherapy: Paclitaxel/Cisplatin
Intervention Type
Drug
Intervention Name(s)
chemotherapy: Paclitaxel/Carboplatin
Intervention Description
Drug: chemotherapy: Paclitaxel/Carboplatin
Primary Outcome Measure Information:
Title
overall survival
Time Frame
During the study conduct
Secondary Outcome Measure Information:
Title
progression-free survival
Time Frame
During the study conduct
Title
response rate
Time Frame
During the study conduct
Title
adverse events
Time Frame
During the study conduct
Title
severe adverse events
Time Frame
During the study conduct
Title
proportion of periods of non-hospitalization to those of the planned treatment
Time Frame
18 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshiharu Kamura, MD, PhD
Organizational Affiliation
Kurume University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Cancer Center Hospital
City
Nagoya,Chikusa-ku,Kanokoden,1-1
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Nagoya Medical Center
City
Nagoya,Naka-ku,Sannomaru,4-1-1
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama,Horinouchi,13
State/Province
Ehime
ZIP/Postal Code
790-0007
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka,Higashi-ku,Maidashi,3-1-1
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
National Kyushu Cancer Center
City
Fukuoka,Minami-ku,Notame,3-1-1
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kurume University School of Medicine
City
Kurume, Asahi-machi, 67
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Gunma Prefectural Cancer Center
City
Ota,Takabayashi-nishi-cho,617-1
State/Province
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
National Hospital Organization Kure Medical Center Chugoku Cancer Center
City
Kure,Aoyama-cho,3-1
State/Province
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
Facility Name
Hokkaido University Hospital
City
North-14 West-5 Kita-ku,Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Sapporo Medical University
City
S-1,W-16,Chuo-ku,Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Hyogo Medical Center for Adults
City
Akashi,Kitaouji-cho,13-70
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Institute of Clinical Medicine,Tsukuba University Hospital
City
Tsukuba,Tennodai,1-1-1
State/Province
Ibaraki
ZIP/Postal Code
305-8575
Country
Japan
Facility Name
Kagoshima City Hospital
City
Kagoshima,Kajiya-cho,20-17
State/Province
Kagoshima
ZIP/Postal Code
892-8580
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai,Aoba-ku,Seiryo-machi,1-1
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Sinshu University
City
Matsumoto,Asahi,3-1-1
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Nagaoka Red Cross Hospital
City
Nagaoka,Terashima-cho,297-1
State/Province
Niigata
ZIP/Postal Code
940-2085
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata,Kawagishi-cho,2-15-3
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka,Higashinari-ku,Nakamichi,1-3-3
State/Province
Osaka
ZIP/Postal Code
537-8511
Country
Japan
Facility Name
Osaka City General Hospital
City
Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Kinki University School of Medicine
City
Osaka-Sayama,Ohno-higashi,377-2
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Faculty of Medicine, Saga University
City
Saga,Nabeshima,5-1-1
State/Province
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Saitama Medical Center, Saitama Medical School
City
Kawagoe,Komoda,1981
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Saitama Cancer Center
City
Kita-adachi,Ina,Komuro,818
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
National Defense Medical College
City
Tokorozawa,Namiki,3-2
State/Province
Saitama
ZIP/Postal Code
359-8513
Country
Japan
Facility Name
Juntendo University School of Medicine
City
Bunkyo-ku,Hongo,3-1-3
State/Province
Tokyo
ZIP/Postal Code
113-0033
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Bunkyo-ku,Hongo,7-3-1
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku,Tsukiji,5-1-1
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Cancer Institute Hospital
City
Koto-ku,Ariake,3-10-6
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Jikei University Hospital
City
Minato-ku,Nishishinbashi,3-25-8
State/Province
Tokyo
ZIP/Postal Code
105-8461
Country
Japan
Facility Name
Tottori University School of Medicine
City
Yonago,Nishimachi,36-1
State/Province
Tottori
ZIP/Postal Code
683-8504
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25732161
Citation
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.
Results Reference
derived
Links:
URL
http://www.jcog.jp/
Description
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Trial of TP Versus TC Regimens for Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)

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