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Recruiting NCT03731442

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

Phase III Interventional Esophageal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Involved field irradiation, Elective field irradiation, Paclitaxel, Platinum.
Who it may be relevant to
Registry conditions: Esophageal Cancer. Basic parameters: 16 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients: A Prospective, Multicenter Clinical Trial

Overview

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.

Detailed description

Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received surgery as their first treatment. 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.

Retrospective data of 218 cases in our hospital indicated patients underwent salvage chemoradiation had significantly improved survival compared with chemotherapy, radiotherapy or best supportive care. For patients with locoregional recurrence, the 1-, 3-year overall survival (OS) rates were statistically higher in patients received salvage chemoradiation than radiotherapy (1-year OS, 70.0% vs. 55.2%, 3-year OS, 41.9% vs. 23.5%, p=0.045). Patients received chemotherapy had 1-year OS of 0%.

Data of 218 cases of our hospital indicated patients received radiation dose \> 54Gy had a significantly longer median overall survival time of 21.2 months compared with 11.3 months in patients had \<54Gy. The optimal radiation dose should be further investigated.

The recurrence pattern of patients with esophageal cancer after esophagectomy mainly consist of supraclavicular and mediastinal lymph nodes. For patients recurred after radical surgery, prophylactic irradiation to high-risk lymph node regions should be considered. The study use simultaneously integrated boost (SIB) intensity-modulated radiation therapy (IMRT) in this trial, which made different radiation dose to recurrent tumor and high-risk lymph node regions possible.

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. Patients were further assigned to receive elective field irradiation (ENI) or involved field irradiation (IFI) according to tumor size, tumor location and time-to-recurrence.

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

Primary outcome measures

  • 1-, 2-, 3-year overall survival [Time frame: From treatment initiation to death from any cause or censor, assessed up to 36 months]
Secondary outcome measures (4)
  • 1-, 2-, 3-year local progression-free survival [Time frame: From treatment initiation to first documented local progression or death or censor, assessed up to 36 months]
  • 1-, 2-, 3-year progression-free survival [Time frame: From treatment initiation to first documented progression or death or censor, assessed up to 36 months]
  • Simultaneously integrated boost radiation therapy completion rate [Time frame: During chemoradation, assessed up to 60 days]
  • Toxicities according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities [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]

Eligibility criteria

Inclusion criteria

  • 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;
  • No prior therapy after recurrence;
  • Age 16-70 years;
  • KPS>70;
  • No history of drug allergy;
  • Sufficient liver and kidney functions;
  • White blood cell count > 4.0\*10\^9/L.

Exclusion criteria

  • Age>70 or <16 years;
  • Pregnancy or lactation;
  • History of drug allergy;
  • Declining informed consent;
  • Insufficient liver or kidney functions, or abnormal CBC test;
  • Severe cardiovascular diseases, infections, active ulcerations, diabetes mellitus with unstable blood sugar, mental disorders.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Radiation Oncology, National Cancer Center/National Clinical Research Center — Beijing

Publications

  • Chang X, Deng L, Ni W, Li C, Han W, Gao LR, Wang S, Zhou Z, Chen D, Feng Q, Liang J, Bi N, Lv J, Gao S, Mao Y, Xue Q, Xiao Z. Salvage chemoradiation therapy for recurrence after radical surgery or palliative surgery in esophageal cancer patients: a prospective, multicenter clinical trial protocol. BMC Cancer. 2020 Sep 14;20(1):877. doi: 10.1186/s12885-020-07315-0. PMID 32928136

Identifiers

NCT: NCT03731442 · 18-175/1753

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗