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

ConditionEsophageal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16-70
SponsorChinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Locoregional recurrence after radical surgery;

Positive resection margin (R1/R2) after surgery;

Out-of-field recurrence after adjuvant chemoradiation or radiotherapy;

Recurrence after adjuvant chemotherapy;

Disqualifiers

Age>70 or <16 years;

Pregnancy or lactation;

History of drug allergy;

Declining informed consent;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Involved field irradiation

    Radiation

    Involved field irradiation; intensity-modulated radiation therapy

  • Elective field irradiation

    Radiation

    Elective field irradiation; intensity-modulated radiation therapy

  • Paclitaxel

    Drug

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

  • Platinum

    Drug

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

  • PEG-rhG-CSF

    Drug

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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Involved field irradiationExperimental treatment 4 interventions
Group B: Elective field irradiationExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

1-, 2-, 3-year overall survival

Overall survival

Time frame
From treatment initiation to death from any cause or censor, assessed up to 36 months

Secondary outcomes

1

1-, 2-, 3-year local progression-free survival

Local progression-free survival

Time frame
From treatment initiation to first documented local progression or death or censor, assessed up to 36 months
2

1-, 2-, 3-year progression-free survival

Progression-free survival

Time frame
From treatment initiation to first documented progression or death or censor, assessed up to 36 months
3

Simultaneously integrated boost radiation therapy completion rate

Radiation therapy completion rate

Time frame
During chemoradation, assessed up to 60 days
4

Toxicities according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities

Toxicities of chemoradiation therapy

Time frame
Assessed within 3 months from initiation of chemoradiaiton (acute), and 3 months after initiation of chemoradiation (late), according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities

Other outcomes

Sponsors and contacts

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

Chinese Academy of Medical Sciences

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborator

Tianjin Medical University Cancer Institute and Hospital

Collaborator

Anyang Tumor Hospital

Collaborator

Fujian Cancer Hospital

Collaborator

Peking University Cancer Hospital & Institute

Collaborator

Hebei Medical University Fourth Hospital

Collaborator

Source ClinicalTrials.gov
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