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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00770874
Recruitment Status : Completed
First Posted : October 10, 2008
Results First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE October 9, 2008
First Posted Date  ICMJE October 10, 2008
Results First Submitted Date  ICMJE October 22, 2018
Results First Posted Date  ICMJE June 21, 2019
Last Update Posted Date June 21, 2019
Study Start Date  ICMJE September 2008
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
Overall survival [ Time Frame: Once every 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
Progression free survival, Overall response rate, safety [ Time Frame: Once every 3 months (PFS), Once every 6 weeks (ORR), anytime (safety) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer
Official Title  ICMJE Phase III Study of S-1 + Cisplatin Compared With Single-agent Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • 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.
  • Drug: Cisplatin (arm B)
    Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
Study Arms  ICMJE
  • Experimental: 1
    S-1 + Cisplatin (arm A)
    Intervention: Drug: S-1 + Cisplatin (arm A)
  • Active Comparator: 2
    Cisplatin (arm B)
    Intervention: Drug: Cisplatin (arm B)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2016)
375
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2008)
360
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00770874
Other Study ID Numbers  ICMJE 10020380
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Taiho Pharmaceutical Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Taiho Pharmaceutical Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Taiho Pharmaceutical Co., Ltd.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP