Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Taiho Pharmaceutical Co., Ltd. |
---|---|
Information provided by: | Taiho Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00770874 |
This study is an open-label, multicenter, multinational, two-arm, parallel randomized Phase 3 study evaluating the efficacy and safety of S-1+Cisplatin versus single-agent Cisplatin in patients with stage IVB, recurrent or persistent carcinoma of the cervix.
Condition | Intervention | Phase |
---|---|---|
Cervical Cancer |
Drug: S-1 + Cisplatin (arm A) Drug: Cisplatin (arm B) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase III Study of S-1 + Cisplatin Compared With Single-Agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix |
Estimated Enrollment: | 360 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
S-1 + Cisplatin (arm A)
|
Drug: S-1 + Cisplatin (arm A)
S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks.
|
2: Active Comparator
Cisplatin (arm B)
|
Drug: Cisplatin (arm B)
Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
|
Japanese phase II study of S-1 in cervical cancer suggested promising response rate and good tolerability. Since recommended chemotherapy for metastatic or recurrent cervical carcinoma is either single-agent Cisplatin or Cisplatin-based combination chemotherapy, this is designed to evaluate the efficacy and safety of S-1 in combination with Cisplatin compared with single-agent Cisplatin.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If the patient have received chemotherapy, radiotherapy or chemoradiotherapy as previous treatment, following interval must have elapsed from the last administration of treatment:
If there have been residual disease in previously irradiated field and without disease progression since the (chemo) radiotherapy, 90 days must have elapsed after the last administration of irradiation.
Patients who have adequate hematologic, hepatic and renal functions as defined below:
Exclusion Criteria:
Contact: Masahiro Takeuchi | +81-3-5791-6400 | ctcc@insti.kitasato-u.ac.jp |
Japan, Tokyo | |
Cancer Institute Hospital | Recruiting |
3-10-6, Ariake, Koto-ku, Tokyo, Japan, 135-8550 | |
Contact: Yasuo Hirai, MD +81-3-3520-0111 | |
Principal Investigator: Yasuo Hirai, MD | |
Korea, Republic of, Seoul | |
Seoul National University Hospital | Recruiting |
28 Yeongeon-dong, Jongno-gu, Seoul, Korea, Republic of, 110-744 | |
Contact: Soon-Beom Kang, MD +82-2-2072-2380 | |
Principal Investigator: Soon-Beom Kang, MD | |
Taiwan, TaoYuan Hsien | |
Chang Gung Memorial Hospital Linkou | Recruiting |
5. Fu-Hsing St. Kuei Shan Hsiang, TaoYuan Hsien, Taiwan, 33305 | |
Contact: Ting-Chang Chang, MD +886-3-3281200 | |
Principal Investigator: Ting-Chang Chang, MD |
Study Chair: | Ken Takizawa, MD | Cancer Institute Hospital |
Study Chair: | Toshiharu Kamura, MD | Kurume University |
Study Chair: | Ting-Chang Chang, MD | Chang Gung Memorial Hospital Linkou |
Study Chair: | Soon-Beom Kang, MD | Seoul National University Hospital |
Responsible Party: | Taiho Pharmaceutical Co., Ltd. ( Taiho Pharmaceutical Co., Ltd. ) |
Study ID Numbers: | 10020380 |
Study First Received: | October 9, 2008 |
Last Updated: | January 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00770874 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Radiation-Sensitizing Agents Cisplatin Recurrence Carcinoma |
Radiation-Sensitizing Agents Cisplatin Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |