Trial of TP Versus TC Regimens for Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)
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ClinicalTrials.gov Identifier: NCT00295789 |
Recruitment Status :
Completed
First Posted : February 24, 2006
Last Update Posted : September 22, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uterine Cervical Neoplasms | Drug: chemotherapy: Paclitaxel/Cisplatin Drug: chemotherapy: Paclitaxel/Carboplatin | Phase 3 |
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 |
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 |
- overall survival [ Time Frame: During the study conduct ]
- progression-free survival [ Time Frame: During the study conduct ]
- response rate [ Time Frame: During the study conduct ]
- adverse events [ Time Frame: During the study conduct ]
- severe adverse events [ Time Frame: During the study conduct ]
- proportion of periods of non-hospitalization to those of the planned treatment [ Time Frame: 18 weeks ]
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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 |
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
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
Study Chair: | Toshiharu Kamura, MD, PhD | Kurume University School of Medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
cervical cancer palliative chemotherapy recurrent persistent |
stageⅣb cisplatin carboplatin paclitaxel |
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 |