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ESO-Shanghai9: Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma

Sponsor
Fudan University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02916511
Collaborator
(none)
70
Enrollment
1
Location
1
Arm
81.9
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chemo-radiation group

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

Drug: Carboplatin
carboplatin AUC=2, ivgtt, d1, qw*5

Radiation: Radiotherapy
1.8Gy/d, d1-5/week, 25Fx

Outcome Measures

Primary Outcome Measures

  1. Local control rate [2 years]

Secondary Outcome Measures

  1. overall survival [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
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:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fudan Universtiy Shanghai Cancer Center Shanghai Shanghai China 200032

Sponsors and Collaborators

  • Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kuai Le Zhao, MD, Professor, Fudan University
ClinicalTrials.gov Identifier:
NCT02916511
Other Study ID Numbers:
  • ESO-Shanghai9
First Posted:
Sep 27, 2016
Last Update Posted:
Jul 7, 2021
Last Verified:
Jul 1, 2021
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Paclitaxel
Carboplatin

Study Results

No Results Posted as of Jul 7, 2021