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Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients

NCT03731442 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-12-12

No results posted yet for this study

Summary

Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received radical surgery. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation. The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery.

Conditions

  • Esophageal Cancer

Interventions

RADIATION

Involved field irradiation

Involved field irradiation; intensity-modulated radiation therapy

RADIATION

Elective field irradiation

Elective field irradiation; intensity-modulated radiation therapy

DRUG

Paclitaxel

Paclitaxel 135-150mg/m2, d1, every 3 weeks

DRUG

Platinum

for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;

DRUG

PEG-rhG-CSF

PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER

  • Anyang Tumor Hospital

    collaborator OTHER

  • Fujian Cancer Hospital

    collaborator OTHER_GOV

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Hebei Medical University Fourth Hospital

    collaborator OTHER

  • Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2022-10-31
Completion
2027-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03731442 on ClinicalTrials.gov