NCT02677597

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
268

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 9, 2016

Status Verified

February 1, 2016

Enrollment Period

3 years

First QC Date

February 5, 2016

Last Update Submit

February 8, 2016

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • PFS

    Since the date of random to disease progression or any cause of death，the average time is 2 years

Study Arms (2)

Cisplatin Combined With S-1

EXPERIMENTAL

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

Cisplatin Combined With Paclitaxel

EXPERIMENTAL

Cisplatin 75mg/m2 ivgtt d1 Paclitaxel 175mg/m2 d1 ivgtt 3h

Drug: Cisplatin Combined With Paclitaxel

Interventions

Cisplatin Combined With S-1DRUG
Cisplatin Combined With S-1
Cisplatin Combined With PaclitaxelDRUG
Cisplatin Combined With Paclitaxel

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • \~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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

S 1 (combination)Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Central Study Contacts

Chang J Hua, PD

CONTACT

13916619284changjianhua@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 9, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

February 9, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

Locations

CN(1)