NCT02459457

Brief Summary

The purpose of this study is to determined the best scheme in paclitaxel and cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with radiotherapy for patients with local advanced esophageal Squamous Cell Carcinoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
321

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 23, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

5 years

First QC Date

May 23, 2015

Last Update Submit

February 8, 2022

Conditions

Stage III Esophageal Squamous Cell Carcinoma

Keywords

esophageal squamous cell carcinomaconcurrent chemoradiotherapypaclitaxelcisplatincarboplatinfluorouracil

Outcome Measures

Primary Outcomes (1)

  • overall survival

    3 years

Secondary Outcomes (2)

  • progression free survival

    1year, 2 years, 3 years

  • adverse event

    3 years

Study Arms (3)

Paclitaxel and Cisplatin (TP)

ACTIVE COMPARATOR

Patients receive TP concurrent with radiotherapy (1.8Gy/d, d1-5/week, 34Fx) Paclitaxel: 175mg/m2/d, ivgtt over 3 hours, d1; Cisplatin: 25mg/m2/d, ivgtt, d1-3, q4w\*4

Drug: Paclitaxel and CisplatinRadiation: Radiotherapy

Paclitaxel and Fluorouracil (TF)

ACTIVE COMPARATOR

Patients receive TF concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; 5-FU 300mg/m2, civ 96h, d1-4, qw\*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; 5-FU 1800mg/m2, civ 72h, d1-3, q4w\*2

Drug: Paclitaxel and FluorouracilRadiation: Radiotherapy

Paclitaxel and Carboplatin（TC）

ACTIVE COMPARATOR

Patients receive TC concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=2, ivgtt, d1, qw\*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=5, ivgtt, d1, q4w\*2

Drug: Paclitaxel and CarboplatinRadiation: Radiotherapy

Interventions

Paclitaxel and CisplatinDRUG

patients get Paclitaxel and Cisplatin according to protocol

Also known as: TP
Paclitaxel and Cisplatin (TP)
Paclitaxel and FluorouracilDRUG

patients get Paclitaxel and Fluorouracil according to protocol

Also known as: TF
Paclitaxel and Fluorouracil (TF)
Paclitaxel and CarboplatinDRUG

patients get Paclitaxel and Carboplatin according to protocol

Also known as: TC
Paclitaxel and Carboplatin（TC）
RadiotherapyRADIATION

1.8Gy/d, d1-5/week, 34Fx

Paclitaxel and Carboplatin（TC）Paclitaxel and Cisplatin (TP)Paclitaxel and Fluorouracil (TF)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be eligible for this study, patient must fulfill all of the following criteria:
  • Histologically confirmed esophageal squamous cell carcinoma
  • Clinical stages II, III or IVa based on the 6th UICC-TNM classification
  • No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD.
  • Aged 18-75 years
  • Adequate organ functions
  • White blood cell (WBC) ≥3×109⁄L
  • Absolute neutrophil counts (ANC) ≥1.5×109⁄L
  • Hemoglobin (Hb) ≥10g⁄dl
  • Platelet (Plt) ≥100×109⁄L
  • Total bilirubin \<1.5 upper limit of normal (ULN)
  • Aspartate transaminase (AST) ≤2.5 ULN
  • Alanine aminotransferase (ALT) ≤2.5 ULN
  • Creatinine ≤1.5 ULN
  • ECOG PS of 0-2
  • +2 more criteria

You may not qualify if:

  • Esophageal perforation or hematemesis
  • Synchronous or metachronous malignancies (except for cutaneous (non-melanomas) carcinoma, thyroid papillary carcinoma, phase I seminoma or cervical carcinoma in situ curatively treated and disease free for a minimum of 3 months)
  • Received thoracic, abdominal or craniocerebral surgery within 30 days
  • Enrolled in other clinical trials within 30 days
  • Unstable angina and/or congestive heart failure requiring hospitalization within 6 months
  • Severe psychiatric disease
  • Pregnancy, lactation or unwillingness to adopt contraception
  • Drug addiction
  • Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
  • Patients with hearing impairment or sensory-motor neuropathy of WHO grade \> 1
  • History of radiotherapy in the planning area
  • Other ineligible conditions according to researchers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (2)

  • Ai D, Ye J, Wei S, Li Y, Luo H, Cao J, Zhu Z, Zhao W, Lin Q, Yang H, Zheng X, Zhou J, Huang G, Li L, Li J, Zhang Z, Zhou G, Gu D, Du M, Mo M, Jia H, Zhang Z, Zhao K. Comparison of 3 Paclitaxel-Based Chemoradiotherapy Regimens for Patients With Locally Advanced Esophageal Squamous Cell Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220120. doi: 10.1001/jamanetworkopen.2022.0120.

    PMID: 35188552DERIVED

  • Ai D, Chen Y, Liu Q, Zhang J, Deng J, Zhu H, Ren W, Zheng X, Li Y, Wei S, Ye J, Zhou J, Lin Q, Luo H, Cao J, Li J, Huang G, Wu K, Fan M, Yang H, Zhu Z, Zhao W, Li L, Fan J, Badakhshi H, Zhao K. Comparison of paclitaxel in combination with cisplatin (TP), carboplatin (TC) or fluorouracil (TF) concurrent with radiotherapy for patients with local advanced oesophageal squamous cell carcinoma: a three-arm phase III randomized trial (ESO-Shanghai 2). BMJ Open. 2018 Oct 21;8(10):e020785. doi: 10.1136/bmjopen-2017-020785.

    PMID: 30344165DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

TP protocolPaclitaxelFluorouracilCarboplatinRadiotherapy

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 ChemicalsDiterpenesTerpenesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoordination ComplexesTherapeutics

Study Officials

  • Kuaile Zhao, MD

    +86 18017312534

    STUDY CHAIR

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
Professor

Study Record Dates

First Submitted

May 23, 2015

First Posted

June 2, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2020

Study Completion

February 1, 2022

Last Updated

February 9, 2022

Record last verified: 2022-02

Locations

CN(1)