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Uterine Cervical NeoplasmsPhase 3NCT00295789

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

A Phase 3 study testing chemotherapy: Paclitaxel/Cisplatin and chemotherapy: Paclitaxel/Carboplatin in people with Uterine Cervical Neoplasms, run by Haruhiko Fukuda at 30 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 75 years, women only
Conditions the study is for
Uterine Cervical Neoplasms
What is being tested?
chemotherapy: Paclitaxel/Cisplatin and chemotherapy: Paclitaxel/Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
253 participants
Where
30 sitesJapan
Study dates
Feb 2006to Nov 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • patients who have some neurologically functional disorder
  • symptomatic CNS metastasis
  • hypersensitive to alcohol
  • active infection
  • HBs antigen positive
  • uncontrollable hypertension
Show all 13Show fewer
  • 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

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Japan30 sites

  • Hyogo Medical Center for Adults

    Akashi,Kitaouji-cho,13-70, Hyōgo, 673-8558

  • Juntendo University School of Medicine

    Bunkyo-ku,Hongo,3-1-3, Tokyo, 113-0033

  • The University of Tokyo Hospital

    Bunkyo-ku,Hongo,7-3-1, Tokyo, 113-8655

  • National Cancer Center Hospital

    Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045

  • Kyushu University Hospital

    Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, 812-8582

  • National Kyushu Cancer Center

    Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, 811-1395

  • Kagoshima City Hospital

    Kagoshima,Kajiya-cho,20-17, Kagoshima-ken, 892-8580

  • Saitama Medical Center, Saitama Medical School

    Kawagoe,Komoda,1981, Saitama, 350-8550

  • Saitama Cancer Center

    Kita-adachi,Ina,Komuro,818, Saitama, 362-0806

  • Cancer Institute Hospital

    Koto-ku,Ariake,3-10-6, Tokyo, 135-8550

  • National Hospital Organization Kure Medical Center Chugoku Cancer Center

    Kure,Aoyama-cho,3-1, Hiroshima, 737-0023

  • Kurume University School of Medicine

    Kurume, Asahi-machi, 67, Fukuoka, 830-0011

  • Sinshu University

    Matsumoto,Asahi,3-1-1, Nagano, 390-8621

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama,Horinouchi,13, Ehime, 790-0007

  • Jikei University Hospital

    Minato-ku,Nishishinbashi,3-25-8, Tokyo, 105-8461

  • Nagaoka Red Cross Hospital

    Nagaoka,Terashima-cho,297-1, Niigata, 940-2085

  • Aichi Cancer Center Hospital

    Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681

  • Nagoya Medical Center

    Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi-ken, 460-0001

  • Niigata Cancer Center Hospital

    Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566

  • Hokkaido University Hospital

    North-14 West-5 Kita-ku,Sapporo, Hokkaido, 060-8648

  • Kinki University School of Medicine

    Osaka-Sayama,Ohno-higashi,377-2, Osaka, 589-8511

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511

  • Osaka City General Hospital

    Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, 534-0021

  • Gunma Prefectural Cancer Center

    Ota,Takabayashi-nishi-cho,617-1, Gunma, 373-8550

  • Sapporo Medical University

    S-1,W-16,Chuo-ku,Sapporo, Hokkaido, 060-8543

  • Faculty of Medicine, Saga University

    Saga,Nabeshima,5-1-1, Saga-ken, 849-8501

  • Tohoku University Hospital

    Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, 980-8574

  • National Defense Medical College

    Tokorozawa,Namiki,3-2, Saitama, 359-8513

  • Institute of Clinical Medicine,Tsukuba University Hospital

    Tsukuba,Tennodai,1-1-1, Ibaraki, 305-8575

  • Tottori University School of Medicine

    Yonago,Nishimachi,36-1, Tottori, 683-8504

Other trials in Japan

About this study

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)

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

Read the 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.

Being tested
chemotherapy: Paclitaxel/Cisplatin, chemotherapy: Paclitaxel/Carboplatin
Keywords
cervical cancer, palliative chemotherapy, recurrent, persistent, stageⅣb, cisplatin, carboplatin, paclitaxel
Medical subject headings
Uterine Cervical Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chemotherapy: Paclitaxel/CisplatinDrug

    Drug: chemotherapy: Paclitaxel/Cisplatin

  • chemotherapy: Paclitaxel/CarboplatinDrug

    Drug: chemotherapy: Paclitaxel/Carboplatin

Study groups in NCT00295789
Study groupRoleWhat they receive
1Active comparatorDrug: chemotherapy: Paclitaxel/Cisplatin
Receives: Drug: chemotherapy: Paclitaxel/Cisplatin
2ExperimentalDrug: chemotherapy: Paclitaxel/Carboplatin
Receives: Drug: chemotherapy: Paclitaxel/Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    Measured: During the study conduct

Secondary outcomes (5)

  1. progression-free survival

    Measured: During the study conduct

  2. response rate

    Measured: During the study conduct

  3. adverse events

    Measured: During the study conduct

  4. severe adverse events

    Measured: During the study conduct

  5. proportion of periods of non-hospitalization to those of the planned treatment

    Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00295789
Sponsor's protocol ID
JCOG0505
Other IDs
C000000335
Status last verified
Sep 2016
First submitted
23 Feb 2006
Last updated
22 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25732161

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing chemotherapy: Paclitaxel/Cisplatin and chemotherapy: Paclitaxel/Carboplatin in people with Uterine Cervical Neoplasms, run by Haruhiko Fukuda at 30 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: During the study conduct). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00295789, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.

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