Cervical Cancer Clinical Trial
Official title:
Phase III Study of S-1 + Cisplatin Compared With Single-agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix
NCT number | NCT00770874 |
Other study ID # | 10020380 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | September 2008 |
Est. completion date | April 2016 |
Verified date | March 2019 |
Source | Taiho Pharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 375 |
Est. completion date | April 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Patients with histologically proven cervical carcinoma (All histological subtype will be included). - Patients who have stage IVB, recurrent or persistent disease. - Patients who are not amenable to curative treatment with surgery and/or radiotherapy. - Patients who have not received chemotherapy or chemoradiotherapy after diagnosis of recurrent, persistent, or stage IVB disease. - If the patient have received chemotherapy, radiotherapy or chemoradiotherapy as previous treatment, following interval must have elapsed from the last administration of treatment: 1. Chemotherapy: 21 days 2. Radiotherapy: 21 days* 3. Chemoradiotherapy: 42 days* 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: - Hemoglobin: = 8.0 g/dL - Neutrophil count: = 2,000/mm^3 - Platelet count: = 100,000/mm^3 - Total serum bilirubin: = 1.5 times the upper limits of normal (ULN) - AST (GOT), ALT (GPT): = 2.5 times the ULN. If abnormal values are associated with hepatic metastasis: = 5.0 times the ULN - Serum creatinine: = ULN or creatinine clearance: = 50 ml/min - Patients who have an ECOG performance status : 0-1. - Age: = 20 years old. - Patients who can take pills orally. - Patients who signed the written consent form. Exclusion Criteria: - Patients who have known hypersensitivity to 5-FU or Cisplatin. - Patients who are receiving concomitant treatment with drugs interacting with S-1. - Patients who are receiving concomitant treatment with drugs interacting with Cisplatin. - Patients who were administered other investigational products within 30 days before the initiation of study treatment. - Patients who were previously treated with S-1. - Patients who had received platinum-containing chemotherapy or chemoradiotherapy and whose disease progressed during the therapy. - Patients who suffer from active infection (e.g. fever = 38°C). - Patients who have serious complications. - Patients with bleeding which requires hemostasis treatment. - Patients with bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. - Patients with uncontrolled pleural effusion and/or ascites requiring drainage at least twice a week. - Patients with symptomatic brain metastasis or history of brain metastasis. - Patients who have unmanageable bowel movement (ex. Watery stool, chronic constipation). - Patients with active double cancer. - Patients who are pregnant or lactating. - Patients who are considered to be inappropriate to the subject of this study by the investigator. |
Country | Name | City | State |
---|---|---|---|
Japan | Cancer Institute Hospital | Ariake, Koto-ku | Tokyo |
Japan | Yanagawa Hospital | Chikushimachi, Yanagawa | Fukuoka |
Korea, Republic of | Konkuk University Medical Center | Hwayang-dong, Gwangjin-gu | Seoul |
Taiwan | Chang Gung Medical Foundation- Linkou | Fu-Hsing Saint Kuei Shan Hsiang | TaoYuan Hsien |
Lead Sponsor | Collaborator |
---|---|
Taiho Pharmaceutical Co., Ltd. |
Japan, Korea, Republic of, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | From the date of randomization to death from any cause, assessed up to 296 events or the end of November 2015, whichever was earlier, each three months | ||
Secondary | Progression Free Survival, Safety | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | About Progression free survival, from the randomization to disease progression or death, whichever came first, assessed up to until primary outcome came each three months, and about safety, from the first treatment to 30 days after the last treatment |
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