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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00295789
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : September 22, 2016
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group

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

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : February 2006
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. overall survival [ Time Frame: During the study conduct ]

Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: During the study conduct ]
  2. response rate [ Time Frame: During the study conduct ]
  3. adverse events [ Time Frame: During the study conduct ]
  4. severe adverse events [ Time Frame: During the study conduct ]
  5. proportion of periods of non-hospitalization to those of the planned treatment [ Time Frame: 18 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295789


Locations
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Sponsors and Collaborators
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Investigators
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Study Chair: Toshiharu Kamura, MD, PhD Kurume University School of Medicine
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00295789    
Other Study ID Numbers: JCOG0505
C000000335 ( Registry Identifier: UMIN-CTR )
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Keywords provided by Haruhiko Fukuda, Japan Clinical Oncology Group:
cervical cancer
palliative chemotherapy
recurrent
persistent
 stageⅣb
cisplatin
carboplatin
paclitaxel
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action