NCT02916511

Brief Summary

The purpose of this study is to evaluate safety and 2-year local control rate for extensive clinical target volumes in postoperative radiotherapy concurrent with chemotherapy for esophageal squamous cell carcinoma.

Trial Health

87
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
Completed

Started Sep 2016

Longer than P75 for phase_2

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

Study Start

First participant enrolled

September 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

4.8 years

First QC Date

September 26, 2016

Last Update Submit

December 21, 2023

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Local control rate

    2 years

Secondary Outcomes (1)

  • overall survival

    5 years

Study Arms (1)

Chemo-radiation group

EXPERIMENTAL

A total dose of 45Gy will be delivered in 25 fractions at 1.8Gy/fraction, 5 fractions per week in 5 weeks. The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and celiac nodes. Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw\*5

Drug: PaclitaxelDrug: CarboplatinRadiation: Radiotherapy

Interventions

PaclitaxelDRUG

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

Chemo-radiation group
CarboplatinDRUG

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

Chemo-radiation group
RadiotherapyRADIATION

1.8Gy/d, d1-5/week, 25Fx

Chemo-radiation 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 Universtiy Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (2)

  • 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

  • Ai D, Chen Y, Liu Q, Deng J, Zhang X, Zhang J, Chu L, Shen J, Ma L, Zhang Y, Chen H, Miao L, Zhao K, Xiang J. Extensive clinical target volume in postoperative chemoradiotherapy for esophageal squamous cell carcinoma: a phase II clinical trial (ESO-Shanghai 9). Radiat Oncol. 2023 Feb 7;18(1):26. doi: 10.1186/s13014-023-02211-w.

    PMID: 36750858DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

PaclitaxelCarboplatinRadiotherapy

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 ChemicalsDiterpenesTerpenesCoordination ComplexesTherapeutics

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
Professor

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 27, 2016

Study Start

September 1, 2016

Primary Completion

July 1, 2021

Study Completion

July 1, 2023

Last Updated

December 22, 2023

Record last verified: 2023-12

Locations

CN(1)