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Phase III Study of S-1 + Cisplatin Compared With Single-agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix


Phase 3
20 Years
N/A
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

Phase III Study of S-1 + Cisplatin Compared With Single-agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

Once every 3 months

Safety Issue:

No

Principal Investigator

Ken Takizawa, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute Hospital

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

10020380

NCT ID:

NCT00770874

Start Date:

September 2008

Completion Date:

September 2014

Related Keywords:

  • Cervical Cancer
  • Uterine Cervical Neoplasms

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