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Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02677597
Recruitment Status : Unknown
Verified February 2016 by Chang Jian Hua, Fudan University.
Recruitment status was:  Recruiting
First Posted : February 9, 2016
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Chang Jian Hua, Fudan University

Brief Summary:
Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Cisplatin Combined With S-1 Drug: Cisplatin Combined With Paclitaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Multicenter, Randomized Phase III Clinical Study on Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
Study Start Date : January 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cisplatin Combined With S-1
Cisplatin 75mg/m2 ivgtt d1 S-1 BSA<1.5 50mg bid,BSA≥1.5 60mg bid po d1-14
Drug: Cisplatin Combined With S-1
Experimental: Cisplatin Combined With Paclitaxel
Cisplatin 75mg/m2 ivgtt d1 Paclitaxel 175mg/m2 d1 ivgtt 3h
Drug: Cisplatin Combined With Paclitaxel



Primary Outcome Measures :
  1. PFS [ Time Frame: Since the date of random to disease progression or any cause of death,the average time is 2 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven primary thoracic esophageal squamous cell carcinoma
  • Not suitable for surgery or radio or chemical therapy
  • Presence of at least one index lesion measurable by CT scan or MRI radiation therapy ended at least 4 weeks, but part of the radiation does not as a measurable lesions
  • 18~70 years
  • PS:0-1
  • Life expectancy of ≥ 3 months
  • WBC≥3.5×109/L,ANC≥1.5×109/L, PLT≥100×109/L, Hb≥100g/L
  • TB ≤ 1.5UNL, ALT/AST ≤ 2.5×UNL
  • Scr≥60 mL/min
  • Normal electrocardiogram (ecg)
  • Can normal oral drugs
  • Signed written informed consent

Exclusion Criteria:

  • Breast-feeding or pregnant women, no effective contraception if risk of conception exists
  • Chronic diarrhea, enteritis, intestine obstruction which are not under control
  • Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
  • A second primary tumor (except skin basal cell carcinoma)
  • The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension
  • With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or - CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms
  • With bleeding tendency
  • Has inherited bleeding evidence of physical or blood coagulation disorder
  • With clear chemotherapy drug allergy
  • Other researchers believe that patients should not participate in this testing

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): NCT02677597


Contacts
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Contact: Chang J Hua, PD 13916619284 changjianhua@163.com

Locations
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China, Shanghai
Cancer hospital Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Chang J hua, PD    13916619284    changjianhua@163.com   
Principal Investigator: Chang J hua, PD         
Sponsors and Collaborators
Fudan University

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Responsible Party: Chang Jian Hua, Chief Physician, Fudan University
ClinicalTrials.gov Identifier: NCT02677597     History of Changes
Other Study ID Numbers: CISPEC study
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action