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Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy

ConditionRadiation Oncology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFujian Medical University Union Hospital

About this trial

The primary objective is to compare surgery with postoperative radiotherapy (PORT) versus surgery, in terms of the overall survival time (OS) in Stage II or III squamous cell esophageal carcinoma with neoadjuvant chemoradiotherapy(nCRT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must not have received any prior anticancer therapy Histologically-confirmed squamous cell carcinoma of the esophagus;

Tumors of the esophagus are located in the thoracic cavity;

Pre-treatment stageⅡ-Ⅲ (AJCC/UICC 8th Edition)

Male or non pregnant female

Disqualifiers

Patients with non-squamous cell carcinoma histology;

Patients with advanced inoperable or metastatic esophageal cancer;

Patients with another previous or current malignant disease；

Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neoadjuvant Radiotherapy Program:

    Radiation

    Gross tumor volume (GTV) should include the primary tumor and involved regional lymph nodes as identified on pre-treatment diagnostic studies. Clinical target volume (CTV) is defined as the primary tumor plus 3cm expansion superiorly and inferiorly along the length of the esophagus and a 1cm radial expansion.The nodal CTV should be defined by a 0.5cm expansion from the nodal GTV.CTV should also include coverage the nodal region(s) in which the involved lymph node(s). A total dose of 45 Gy in 25 fractions is delivered 5 days per week on workdays with intensity modulated radiotherapy (IMRT).

  • Neoadjuvant chemotherapy Program

    Drug

    Chemotherapy is delivered concomitantly and composed of two cycles of Docetaxel 60mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 21 days at the intervals of neoadjuvant radiotherapy.

  • Esophagectomy program:

    Procedure/Surgery

    Patients receive esophagectomy in 4-6 weeks after neoadjuvant neoadjuvant chemotherapy

  • Postoperative radiotherapy program

    Radiation

    A total dose of 18 Gy in10 fractions is delivered 5 days per week on workdays with IMRT.

Treatment groups

537 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 4 interventions
Group B: Group BOther 3 interventions

Trial outcomes

Primary outcomes

1

overall survival

The length of time from enrollment until the time of death

Time frame
From enrollment to 5 years after the end of treatment

Secondary outcomes

1

disease free survival

The length of time from enrollment until the time of progression of disease

Time frame
From enrollment to 5 years after the end of treatment
2

local recurrence rate

The percent of the patient with local recurrence

Time frame
From enrollment to 5 years after the end of treatment
3

Side effects

adverse events according to NCI CTCAE 4.0 criteria

Time frame
From enrollment to 12 weeks after end of the treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Medical University Union Hospital

Lead sponsor

Source ClinicalTrials.gov
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