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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
S-1 + Cisplatin (arm A)
Cisplatin (arm B)
Sponsored by
Taiho Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Yanagawa Hospital
  • Cancer Institute Hospital
  • Konkuk University Medical Center
  • Chang Gung Medical Foundation- Linkou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

S-1 + Cisplatin (arm A)

Cisplatin (arm B)

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Progression Free Survival, Safety
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.

Full Information

First Posted
October 9, 2008
Last Updated
March 18, 2019
Sponsor
Taiho Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00770874
Brief Title
Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
375 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
S-1 + Cisplatin (arm A)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Cisplatin (arm B)
Intervention Type
Drug
Intervention Name(s)
S-1 + Cisplatin (arm A)
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin (arm B)
Intervention Description
Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Progression Free Survival, Safety
Description
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.
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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: Chemotherapy: 21 days Radiotherapy: 21 days* 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Takizawa, MD
Organizational Affiliation
Cancer Institute Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Toshiharu Kamura, MD
Organizational Affiliation
Yanagawa Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ting-Chang Chang, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Soon-Beom Kang, MD
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Yanagawa Hospital
City
Chikushimachi, Yanagawa
State/Province
Fukuoka
ZIP/Postal Code
832-0077
Country
Japan
Facility Name
Cancer Institute Hospital
City
Ariake, Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Konkuk University Medical Center
City
Hwayang-dong, Gwangjin-gu
State/Province
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Facility Name
Chang Gung Medical Foundation- Linkou
City
Fu-Hsing Saint Kuei Shan Hsiang
State/Province
TaoYuan Hsien
ZIP/Postal Code
33305
Country
Taiwan

12. IPD Sharing Statement

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

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