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Active, not recruitingNCT04764227Updated Aug 3, 2023

Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)

A Phase 2 interventional study of Paclitaxel and Carboplatin in Esophagus Cancer, Esophageal Squamous Cell Carcinoma and Chemoradiotherapy, sponsored by Fudan University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-03.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 6 months ago, but the record still lists the study as active, not recruiting.
  • Registered 8 months after the study started (first participant enrolled May 2020, registered Feb 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Esophagus Cancer
  • Esophageal Squamous Cell Carcinoma
  • Chemoradiotherapy
  • Radiation Therapy
  • Postoperative
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 70 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Concurrent chemoradiotherapy group

    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: Paclitaxel · Drug: Carboplatin · Radiation: Radiotherapy

Interventions

  • DrugPaclitaxel

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

  • DrugCarboplatin

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

  • RadiationRadiotherapy

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

06

What researchers measure

Primary outcomes

  1. Local control rate

    Time frame: 2 years

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

07

Study locations

1 site
  • Fudan University Shanghai Cancer Center
    Shanghai, 200032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04764227
Lead sponsor
Fudan University
Responsible party
Kuai Le Zhao, MD (Prof, Fudan University) — Principal investigator
First posted
Feb 21, 2021
Start date
May 30, 2020
Primary completion
Mar 30, 2024 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Aug 3, 2023

Study contacts

Kuaile Zhao
principal investigator · Fudan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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