Phase III Study of S-1 + Cisplatin Compared With Single-agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix
- Patients with histologically proven cervical carcinoma (All histological subtype will
- 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
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.
- 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
- 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
- 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