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

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

Detailed Description
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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.

Official Title
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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)

Conditions
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Uterine Cervical Neoplasms

Intervention / Treatment
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* Drug: chemotherapy: Paclitaxel/Cisplatin
* Drug: chemotherapy: Paclitaxel/Carboplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Drug: chemotherapy: Paclitaxel/Cisplatin | Drug: chemotherapy: Paclitaxel/Cisplatin<br>* Drug: chemotherapy: Paclitaxel/Cisplatin<br>|
| Experimental: 2<br>Drug: chemotherapy: Paclitaxel/Carboplatin | Drug: chemotherapy: Paclitaxel/Carboplatin<br>* Drug: chemotherapy: Paclitaxel/Carboplatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | During the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | During the study conduct | 
| response rate |  | During the study conduct | 
| adverse events |  | During the study conduct | 
| severe adverse events |  | During the study conduct | 
| proportion of periods of non-hospitalization to those of the planned treatment |  | 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, palliative chemotherapy, recurrent, persistent, stageⅣb, cisplatin, carboplatin, paclitaxel