Clinical trial NCT00295789: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Cervical Neoplasms
Keywords: cervical cancer
palliative chemotherapy
recurrent
persistent
stageⅣb
cisplatin
carboplatin
paclitaxel
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2006-02-24
Enrollment: 253
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: overall survival
timeFrame: During the study conduct
Secondary outcomes:
measure: progression-free survival
timeFrame: During the study conduct
measure: response rate
timeFrame: During the study conduct
measure: adverse events
timeFrame: During the study conduct
measure: severe adverse events
timeFrame: During the study conduct
measure: proportion of periods of non-hospitalization to those of the planned treatment
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Nagoya,Chikusa-ku,Kanokoden,1-1
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Nagoya,Naka-ku,Sannomaru,4-1-1
country: Japan
facility: Nagoya Medical Center
state: Aichi
city: Matsuyama,Horinouchi,13
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Fukuoka,Higashi-ku,Maidashi,3-1-1
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Fukuoka,Minami-ku,Notame,3-1-1
country: Japan
facility: National Kyushu Cancer Center
state: Fukuoka
city: Kurume, Asahi-machi, 67
country: Japan
facility: Kurume University School of Medicine
state: Fukuoka
city: Ota,Takabayashi-nishi-cho,617-1
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Kure,Aoyama-cho,3-1
country: Japan
facility: National Hospital Organization Kure Medical Center Chugoku Cancer Center
state: Hiroshima
city: North-14 West-5 Kita-ku,Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: S-1,W-16,Chuo-ku,Sapporo
country: Japan
facility: Sapporo Medical University
state: Hokkaido
city: Akashi,Kitaouji-cho,13-70
country: Japan
facility: Hyogo Medical Center for Adults
state: Hyogo
city: Tsukuba,Tennodai,1-1-1
country: Japan
facility: Institute of Clinical Medicine,Tsukuba University Hospital
state: Ibaraki
city: Kagoshima,Kajiya-cho,20-17
country: Japan
facility: Kagoshima City Hospital
state: Kagoshima
city: Sendai,Aoba-ku,Seiryo-machi,1-1
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Matsumoto,Asahi,3-1-1
country: Japan
facility: Sinshu University
state: Nagano
city: Nagaoka,Terashima-cho,297-1
country: Japan
facility: Nagaoka Red Cross Hospital
state: Niigata
city: Niigata,Kawagishi-cho,2-15-3
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Osaka,Higashinari-ku,Nakamichi,1-3-3
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
state: Osaka
city: Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22
country: Japan
facility: Osaka City General Hospital
state: Osaka
city: Osaka-Sayama,Ohno-higashi,377-2
country: Japan
facility: Kinki University School of Medicine
state: Osaka
city: Saga,Nabeshima,5-1-1
country: Japan
facility: Faculty of Medicine, Saga University
state: Saga
city: Kawagoe,Komoda,1981
country: Japan
facility: Saitama Medical Center, Saitama Medical School
state: Saitama
city: Kita-adachi,Ina,Komuro,818
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Tokorozawa,Namiki,3-2
country: Japan
facility: National Defense Medical College
state: Saitama
city: Bunkyo-ku,Hongo,3-1-3
country: Japan
facility: Juntendo University School of Medicine
state: Tokyo
city: Bunkyo-ku,Hongo,7-3-1
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Chuo-ku,Tsukiji,5-1-1
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku,Ariake,3-10-6
country: Japan
facility: Cancer Institute Hospital
state: Tokyo
city: Minato-ku,Nishishinbashi,3-25-8
country: Japan
facility: Jikei University Hospital
state: Tokyo
city: Yonago,Nishimachi,36-1
country: Japan
facility: Tottori University School of Medicine
state: Tottori
Study officials:
affiliation: Kurume University School of Medicine
name: Toshiharu Kamura, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.