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

• ClinicalTrials.gov Identifier: NCT00295789
• Recruitment Status: Completed
• First Posted: February 24, 2006
• Last Update Posted: September 22, 2016
• Sponsor: Haruhiko Fukuda
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Information provided by (Responsible Party): Haruhiko Fukuda, Japan Clinical Oncology Group

Tracking Information

• First Submitted Date: February 23, 2006
• First Posted Date: February 24, 2006
• Last Update Posted Date: September 22, 2016
• Study Start Date: February 2006
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 18, 2008): overall survival [ Time Frame: During the study conduct ]
• Original Primary Outcome Measures (submitted: February 23, 2006): overall survival

Current Secondary Outcome Measures (submitted: July 18, 2008)

• 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 ]

Original Secondary Outcome Measures (submitted: February 23, 2006)

• progression-free survival
• response rate
• adverse events
• severe adverse events
• proportion of periods of non-hospitalization to those of the planned treatment

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial of TP Versus TC Regimens for Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)
• 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)
• Brief Summary: To evaluate the clinical benefits of Paclitaxel plus Carboplatin compared with Paclitaxel plus Cisplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Uterine Cervical Neoplasms

Intervention

• Drug: chemotherapy: Paclitaxel/Cisplatin
  Drug: chemotherapy: Paclitaxel/Cisplatin
• Drug: chemotherapy: Paclitaxel/Carboplatin
  Drug: chemotherapy: Paclitaxel/Carboplatin

Study Arms

• Active Comparator: 1
  Drug: chemotherapy: Paclitaxel/Cisplatin
  Intervention: Drug: chemotherapy: Paclitaxel/Cisplatin
• Experimental: 2
  Drug: chemotherapy: Paclitaxel/Carboplatin
  Intervention: Drug: chemotherapy: Paclitaxel/Carboplatin

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 13, 2010): 253
• Original Enrollment (submitted: February 23, 2006): 250
• Actual Study Completion Date: November 2011
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00295789
• Other Study ID Numbers: JCOG0505; C000000335 ( Registry Identifier: UMIN-CTR )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Haruhiko Fukuda, Japan Clinical Oncology Group
• Original Responsible Party: Not Provided
• Current Study Sponsor: Haruhiko Fukuda
• Original Study Sponsor: Japan Clinical Oncology Group
• Collaborators: Ministry of Health, Labour and Welfare, Japan

Investigators

• Study Chair: Toshiharu Kamura, MD, PhD; Kurume University School of Medicine

• PRS Account: Japan Clinical Oncology Group
• Verification Date: September 2016