Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy to Treat Esophageal Cancer
Condition: Esophageal Neoplasms
MeSH terms: Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the acute and 2-year late toxicities, the 2-year
      local control and overall survival rates in patients with esophageal squamous cell carcinoma
      receiving simultaneous modulated accelerated radiation therapy concurrent with chemotherapy.
    

Detailed description: 
      Esophageal cancer is one of the most common malignant diseases in China, especially in
      Chaoshan region. Concurrent chemoradiotherapy is the standard non-surgical treatment method
      for this disease and the radiation schedule is about 50.4~60 Gray (Gy) in total, 1.8~2Gy per
      fraction generally. However, although with such comprehensive method, noncontrol of local
      disease or recurrence is still the main reason of failure.

      Most patients with esophageal cancer suffer from malnutrition. A number of factors including
      hypoxic, inflammation, radioresistance and accelerated repopulation may contribute to local
      failures of disease after treatment; therefore a higher radiation biological equivalent dose
      (BED) will improve the local control probability. Although the intergroup 0123 (INT123) trial
      had shown that simply increasing total radiation dose could not gain better local control or
      overall survival rate, however, the ability of this trial to test the potential benefits of
      higher radiation dose could be compromized by the deficiencies within them, such as,
      observation bias,large radiated target volume and usage of conventional radiation technique.
      In other words, the probability that increasing radiation may help improving the control of
      disease should not be denied.

      Modern radiation techniques, such as intensity modulation radiation therapy (IMRT),
      specially, are able to improve the coverage of target volumes and sparing of critical
      structures, while increase the total radiation dose. By using simultaneous modulated
      accelerated radiation therapy (SMART) technique, the doses to the relevant normal organs per
      fraction could be reduced significantly, while the doses to tumor could be increased to
      higher than 2Gy. Thus reach the double goal of protection of normal tissues, increasing total
      radiation Equivalent Uniform Dose (EUD). Dosimetric study has proven the feasibility and
      superiority of SMART-base IMRT in radiation treatment of esophageal cancer, compared with
      conventional technique.

      Overall, SMART-base IMRT concurrent with chemotherapy may improve the local control and
      overall survival rate of patients with esophageal cancer; Meanwhile, the acute and late
      toxicities would be tolerable and slighter than that of conventional technique.
    

Intervention name(s): SMART; PF
Intervention type(s): Radiation; Drug
Intervention description(s): The PTV (planning target volume) of gross tumor will receive radiation dose of 66Gy, 2.2Gy per fraction and the PTV of subclinical disease will receive 54Gy, 1.8Gy per fraction,5 fraction per week.; Concurrent and adjuvant chemotherapy: Cisplatin, 80mg/m2, intravenous on day 1, 5fluorouracil 0.5/m2, intravenous on d1 to d4. Two cycles during radiation treatment on d1 and d28. Two additional cycles after radiation treatment, 4 weeks per cycle.
Other intervention name(s): cisplatin plus 5fluorouracil
Intervention MeSH terms: Cisplatin; Fluorouracil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal squamous cell carcinoma; SMART; IMRT; Chemotherapy