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Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer

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ClinicalTrials.gov Identifier: NCT00770874
Recruitment Status : Completed
First Posted : October 10, 2008
Results First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: S-1 + Cisplatin (arm A) Drug: Cisplatin (arm B) Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study of S-1 + Cisplatin Compared With Single-agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix
Study Start Date : September 2008
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: 1
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.

Active Comparator: 2
Cisplatin (arm B)
Drug: Cisplatin (arm B)
Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 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 Outcome Measures :
  1. Progression Free Survival, Safety [ Time Frame: 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 ]
    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.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770874

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Yanagawa Hospital
Chikushimachi, Yanagawa, Fukuoka, Japan, 832-0077
Cancer Institute Hospital
Ariake, Koto-ku, Tokyo, Japan, 135-8550
Korea, Republic of
Konkuk University Medical Center
Hwayang-dong, Gwangjin-gu, Seoul, Korea, Republic of, 143-729
Chang Gung Medical Foundation- Linkou
Fu-Hsing Saint Kuei Shan Hsiang, TaoYuan Hsien, Taiwan, 33305
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
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Study Chair: Ken Takizawa, MD Cancer Institute Hospital
Study Chair: Toshiharu Kamura, MD Yanagawa Hospital
Study Chair: Ting-Chang Chang, MD Chang Gung Memorial Hospital
Study Chair: Soon-Beom Kang, MD Konkuk University Medical Center
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Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00770874    
Other Study ID Numbers: 10020380
First Posted: October 10, 2008    Key Record Dates
Results First Posted: June 21, 2019
Last Update Posted: June 21, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Antineoplastic Agents