Clinical trial NCT00770874: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Cancer
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-10-10
Enrollment: 375
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Survival
timeFrame: 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 outcomes:
measure: Progression Free Survival, Safety
timeFrame: 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
Other outcomes:
Locations:
city: Chikushimachi, Yanagawa
country: Japan
facility: Yanagawa Hospital
state: Fukuoka
city: Ariake, Koto-ku
country: Japan
facility: Cancer Institute Hospital
state: Tokyo
city: Hwayang-dong, Gwangjin-gu
country: Korea, Republic of
facility: Konkuk University Medical Center
state: Seoul
city: Fu-Hsing Saint Kuei Shan Hsiang
country: Taiwan
facility: Chang Gung Medical Foundation- Linkou
state: TaoYuan Hsien
Study officials:
affiliation: Cancer Institute Hospital
name: Ken Takizawa, MD
role: STUDY_CHAIR
affiliation: Yanagawa Hospital
name: Toshiharu Kamura, MD
role: STUDY_CHAIR
affiliation: Chang Gung Memorial Hospital
name: Ting-Chang Chang, MD
role: STUDY_CHAIR
affiliation: Konkuk University Medical Center
name: Soon-Beom Kang, MD
role: STUDY_CHAIR
References: