NCT04764227

Brief Summary

The purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
10mo left

Started May 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress88%
May 2020Mar 2027

Study Start

First participant enrolled

May 30, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Expected
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

3.8 years

First QC Date

February 19, 2021

Last Update Submit

August 1, 2023

Conditions

Esophagus CancerEsophageal Squamous Cell CarcinomaChemoradiotherapyRadiation TherapyPostoperative

Outcome Measures

Primary Outcomes (1)

  • Local control rate

    2 years

Secondary Outcomes (1)

  • Overall survival

    5 years

Study Arms (1)

Concurrent chemoradiotherapy group

EXPERIMENTAL

Interventions: * Chemotherapy: Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw\*5 * Radiotherapy: A total dose of 50.4Gy will be delivered in 28 fractions at 1.8Gy/fraction, 5 fractions per week in 6 weeks. The CTV encompassed the bilateral supraclavicular, superior mediastinal, and subcarinal regions.

Drug: PaclitaxelDrug: CarboplatinRadiation: Radiotherapy

Interventions

PaclitaxelDRUG

paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw\*5

Concurrent chemoradiotherapy group
CarboplatinDRUG

carboplatin AUC=2, ivgtt, d1, qw\*5

Concurrent chemoradiotherapy group
RadiotherapyRADIATION

1.8Gy/d, d1-5/week, 28Fx

Concurrent chemoradiotherapy group

Eligibility Criteria

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

You may qualify if:

  • Joined the study voluntarily and signed informed consent form;
  • Age 18-75;
  • ECOG 0-2;
  • Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
  • The operative incision healed well;
  • T3-4N0M0, T1-4N1-3M0 (according to AJCC2009);
  • No radiotherapy, chemotherapy or other treatments pre (post) surgery;
  • PS ECOG 0-2;
  • Life expectancy of more than 3 months;
  • Hemoglobin (Hb) ≥ 9 g/dL, WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L, Platelet count (Pt) ≥ 100 x 109/L;
  • Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\< 1.5 x ULN;
  • Renal function: creatinine \< 1.5 x ULN
  • No immuno-deficiency;
  • Use of an effective contraceptive for adults to prevent pregnancy.

You may not qualify if:

  • Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis;
  • Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
  • Participation in other interventional clinical trials within 30 days;
  • Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
  • Drug addiction, Alcoholism or AIDS;
  • Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
  • Unsuitable to be enrolled in the trial in the opinion of the investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Related Publications (1)

  • Shen J, Ai D, Chen Y, Liu Q, Deng J, Hao S, Zhang X, Zhang J, Zhang Y, Chu L, Sun Y, Zhang Y, Xiang J, Miao L, Chen H, Zhu H, Zhao K. Postoperative chemoradiotherapy for esophageal squamous cell Carcinoma: Results from ESO-Shanghai 17 and joint analyses for phase II clinical trials. Clin Transl Radiat Oncol. 2025 Nov 21;57:101073. doi: 10.1016/j.ctro.2025.101073. eCollection 2026 Mar.

    PMID: 41531940DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsEsophageal Squamous Cell Carcinoma

Interventions

PaclitaxelCarboplatinRadiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesTherapeutics

Study Officials

  • Kuaile Zhao

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 21, 2021

Study Start

May 30, 2020

Primary Completion

March 30, 2024

Study Completion (Estimated)

March 30, 2027

Last Updated

August 3, 2023

Record last verified: 2023-08

Locations

CN(1)