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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Japan Clinical Oncology Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00295789
First received: February 23, 2006
Last updated: June 13, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Uterine Cervical Neoplasms
Drug: chemotherapy: Paclitaxel/Cisplatin
Drug: chemotherapy: Paclitaxel/Carboplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • overall survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression-free survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • response rate [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]
  • severe adverse events [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]
  • proportion of periods of non-hospitalization to those of the planned treatment [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 253
Study Start Date: February 2006
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295789

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

Additional Information:
No publications provided

Responsible Party: Toshiharu Kamura, MD, PhD, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00295789     History of Changes
Other Study ID Numbers: JCOG0505, C000000335
Study First Received: February 23, 2006
Last Updated: June 13, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
cervical cancer
palliative chemotherapy
recurrent
persistent
stageⅣb
cisplatin
carboplatin
paclitaxel

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Carboplatin
Cisplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 24, 2014