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

Uterine Cervical Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295789
• Other study ID #: JCOG0505
• Secondary ID: C000000335
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2006
• Last updated: September 20, 2016
• Start date: February 2006
• Est. completion date: November 2011

Study information

• Verified date: September 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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 ?b 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Hyogo Medical Center for Adults	Akashi,Kitaouji-cho,13-70	Hyogo
Japan	Juntendo University School of Medicine	Bunkyo-ku,Hongo,3-1-3	Tokyo
Japan	The University of Tokyo Hospital	Bunkyo-ku,Hongo,7-3-1	Tokyo
Japan	National Cancer Center Hospital	Chuo-ku,Tsukiji,5-1-1	Tokyo
Japan	Kyushu University Hospital	Fukuoka,Higashi-ku,Maidashi,3-1-1	Fukuoka
Japan	National Kyushu Cancer Center	Fukuoka,Minami-ku,Notame,3-1-1	Fukuoka
Japan	Kagoshima City Hospital	Kagoshima,Kajiya-cho,20-17	Kagoshima
Japan	Saitama Medical Center, Saitama Medical School	Kawagoe,Komoda,1981	Saitama
Japan	Saitama Cancer Center	Kita-adachi,Ina,Komuro,818	Saitama
Japan	Cancer Institute Hospital	Koto-ku,Ariake,3-10-6	Tokyo
Japan	National Hospital Organization Kure Medical Center Chugoku Cancer Center	Kure,Aoyama-cho,3-1	Hiroshima
Japan	Kurume University School of Medicine	Kurume, Asahi-machi, 67	Fukuoka
Japan	Sinshu University	Matsumoto,Asahi,3-1-1	Nagano
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama,Horinouchi,13	Ehime
Japan	Jikei University Hospital	Minato-ku,Nishishinbashi,3-25-8	Tokyo
Japan	Nagaoka Red Cross Hospital	Nagaoka,Terashima-cho,297-1	Niigata
Japan	Aichi Cancer Center Hospital	Nagoya,Chikusa-ku,Kanokoden,1-1	Aichi
Japan	Nagoya Medical Center	Nagoya,Naka-ku,Sannomaru,4-1-1	Aichi
Japan	Niigata Cancer Center Hospital	Niigata,Kawagishi-cho,2-15-3	Niigata
Japan	Hokkaido University Hospital	North-14 West-5 Kita-ku,Sapporo	Hokkaido
Japan	Osaka Medical Center for Cancer and Cardiovascular Diseases	Osaka,Higashinari-ku,Nakamichi,1-3-3	Osaka
Japan	Osaka City General Hospital	Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22	Osaka
Japan	Kinki University School of Medicine	Osaka-Sayama,Ohno-higashi,377-2	Osaka
Japan	Gunma Prefectural Cancer Center	Ota,Takabayashi-nishi-cho,617-1	Gunma
Japan	Sapporo Medical University	S-1,W-16,Chuo-ku,Sapporo	Hokkaido
Japan	Faculty of Medicine, Saga University	Saga,Nabeshima,5-1-1	Saga
Japan	Tohoku University Hospital	Sendai,Aoba-ku,Seiryo-machi,1-1	Miyagi
Japan	National Defense Medical College	Tokorozawa,Namiki,3-2	Saitama
Japan	Institute of Clinical Medicine,Tsukuba University Hospital	Tsukuba,Tennodai,1-1-1	Ibaraki
Japan	Tottori University School of Medicine	Yonago,Nishimachi,36-1	Tottori

Sponsors (2)

Lead Sponsor	Collaborator
Haruhiko Fukuda	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		During the study conduct	No
Secondary	progression-free survival		During the study conduct	No
Secondary	response rate		During the study conduct	No
Secondary	adverse events		During the study conduct	Yes
Secondary	severe adverse events		During the study conduct	Yes
Secondary	proportion of periods of non-hospitalization to those of the planned treatment		18 weeks	Yes

External Links

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