Esophageal Neoplasms Clinical Trial
The objective of this study is to determine the optimal radiation dosage used in concurrent chemo-radiotherapy in Chinese population. A dose climbing experiment is carried out with an initiate dose of 50Gy conventionally applied in Western countries.
Esophageal cancer (EC) continues to be a major health burden worldwide. The 5-year survival
rates for esophageal cancer have remained less than 15% over decades, probably because of
ineffective therapies and the detection of late-stage cancers. Concurrent chemo-radiotherapy
was established as one of the viable options for therapy of patients with localized EC
following the results from the landmark trial of the Radiation Therapy Oncology Group (RTOG)
85-01 trial, showing a significant survival advantage of concurrent chemoradiation over
radiation alone.
The use of radiochemotherapy with cisplatin and 5-fluorouracil (5-FU) is a well-accepted
standard for the definitive treatment of esophageal cancer in China which has also been
demonstrated efficacy and good tolerability internationally. The AJCC recommended dose range
of radiotherapy for concurrent therapy is 45-50.4Gy. Moreover, (RTOG) 85-01 trial also
established 50.4 Gy as the standard dose of radiation to be administered concurrently with
chemotherapy. However, the appropriate dose of radiation fit for Chinese remains
controversial. Due to insufficient evidence of EBM, radiation therapist in China always
prescribe a radiation dosage by their own experience. Dosages (e.g. 60-64Gy) significantly
higher than the international standard is commonly used in Chinese EC patients which lead to
a greater likelihood of toxicity. Thus Chinese oncologists are urgent to reach a consensus
about radiation dosage in the standard treatment of local advanced EC.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment
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