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

September 20, 2016 updated by: Haruhiko Fukuda

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)

To evaluate the clinical benefits of Paclitaxel plus Carboplatin compared with Paclitaxel plus Cisplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
253

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
      • Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi, Japan, 460-0001
        • Nagoya Medical Center
    • Ehime
      • Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
        • National Hospital Organization Shikoku Cancer Center
    • Fukuoka
      • Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan, 811-1395
        • National Kyushu Cancer Center
      • Kurume, Asahi-machi, 67, Fukuoka, Japan, 830-0011
        • Kurume University School of Medicine
    • Gunma
      • Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center
    • Hiroshima
      • Kure,Aoyama-cho,3-1, Hiroshima, Japan, 737-0023
        • National Hospital Organization Kure Medical Center Chugoku Cancer Center
    • Hokkaido
      • North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
      • S-1,W-16,Chuo-ku,Sapporo, Hokkaido, Japan, 060-8543
        • Sapporo Medical University
    • Hyogo
      • Akashi,Kitaouji-cho,13-70, Hyogo, Japan, 673-8558
        • Hyogo Medical Center for Adults
    • Ibaraki
      • Tsukuba,Tennodai,1-1-1, Ibaraki, Japan, 305-8575
        • Institute of Clinical Medicine,Tsukuba University Hospital
    • Kagoshima
      • Kagoshima,Kajiya-cho,20-17, Kagoshima, Japan, 892-8580
        • Kagoshima City Hospital
    • Miyagi
      • Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Nagano
      • Matsumoto,Asahi,3-1-1, Nagano, Japan, 390-8621
        • Sinshu University
    • Niigata
      • Nagaoka,Terashima-cho,297-1, Niigata, Japan, 940-2085
        • Nagaoka Red Cross Hospital
      • Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
    • Osaka
      • Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan, 537-8511
        • Osaka Medical Center for Cancer and Cardiovascular Diseases
      • Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan, 534-0021
        • Osaka City General Hospital
      • Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan, 589-8511
        • Kinki University School of Medicine
    • Saga
      • Saga,Nabeshima,5-1-1, Saga, Japan, 849-8501
        • Faculty of Medicine, Saga University
    • Saitama
      • Kawagoe,Komoda,1981, Saitama, Japan, 350-8550
        • Saitama Medical Center, Saitama Medical School
      • Kita-adachi,Ina,Komuro,818, Saitama, Japan, 362-0806
        • Saitama Cancer Center
      • Tokorozawa,Namiki,3-2, Saitama, Japan, 359-8513
        • National Defense Medical College
    • Tokyo
      • Bunkyo-ku,Hongo,3-1-3, Tokyo, Japan, 113-0033
        • Juntendo University School of Medicine
      • Bunkyo-ku,Hongo,7-3-1, Tokyo, Japan, 113-8655
        • The University of Tokyo Hospital
      • Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Koto-ku,Ariake,3-10-6, Tokyo, Japan, 135-8550
        • Cancer Institute Hospital
      • Minato-ku,Nishishinbashi,3-25-8, Tokyo, Japan, 105-8461
        • Jikei University Hospital
    • Tottori
      • Yonago,Nishimachi,36-1, Tottori, Japan, 683-8504
        • Tottori University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. histologically proven uterine cervical cancer
  2. squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix
  3. 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
  4. Patients may have been previously treated with less than 50 Gy of palliative radiation therapy
  5. Patients have received no prior treatment or a certain interval must have elapsed from the last administration of previous treatments including palliative radiation therapy
  6. 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
  7. no prior surgical therapy for metastatic lesions of the lung or inside the pelvic cavity
  8. no bilateral hydronephrosis
  9. no prior chemotherapy including more than two platinum-containing regimens
  10. no prior chemotherapy including taxane
  11. age: 20 to75 years
  12. PS: 0-2
  13. 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
  14. written informed consent

Exclusion Criteria:

  1. patients who have some neurologically functional disorder
  2. symptomatic CNS metastasis
  3. hypersensitive to alcohol
  4. active infection
  5. HBs antigen positive
  6. uncontrollable hypertension
  7. history of myocardiac infarction within six months
  8. unstable angina
  9. uncontrollable diabetes
  10. 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
  11. women during pregnancy or breast-feeding
  12. patients with psychiatric illness
  13. patients who have been treated with the systemic steroids medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1
Drug: chemotherapy: Paclitaxel/Cisplatin
Drug: chemotherapy: Paclitaxel/Cisplatin
Drug: chemotherapy: Paclitaxel/Cisplatin
Experimental: 2
Drug: chemotherapy: Paclitaxel/Carboplatin
Drug: chemotherapy: Paclitaxel/Carboplatin
Drug: chemotherapy: Paclitaxel/Carboplatin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
overall survival
Time Frame: During the study conduct
During the study conduct

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
progression-free survival
Time Frame: During the study conduct
During the study conduct
response rate
Time Frame: During the study conduct
During the study conduct
adverse events
Time Frame: During the study conduct
During the study conduct
severe adverse events
Time Frame: During the study conduct
During the study conduct
proportion of periods of non-hospitalization to those of the planned treatment
Time Frame: 18 weeks
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Haruhiko Fukuda

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, Labour and Welfare, Japan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Toshiharu Kamura, MD, PhD, Kurume University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JCOG0505
  • C000000335 (Registry Identifier: UMIN-CTR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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