Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Intervention: S-1 + Cisplatin (arm A); Cisplatin (arm B)
Intervention description: 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.; Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
Intervention MeSH terms: Cisplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 375.0
Sex: Female
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.