Esophageal Cancer Clinical Trial
Official title:
A Phase II Study of Stereotactic Body Radiation Therapy and ZADAXIN's® (Thymalfasin) Induced Tumor Effects in Patients With Heavily Pretreated, Metastatic Esophageal Cancer
Patients with esophageal cancer that had metastatic lesions after been treated with
definitive surgery or chemoradiotherapy are being asked to participate in this study.
1. To observe immunity-mediated tumor response after Stereotactic Body Radiation
Therapy(SBRT) of a metastatic site in metastatic esophageal cancer patients.
2. To induce the efficacy (effectiveness) of a new combination of therapy, SBRT and
thymalfasin for heavily pretreated, metastatic esophageal cancer patients; This study
will help find out what effects (good or bad) the combination of radiotherapy and
thymalfasin has on metastatic esophageal cancer.
1. To observe immunity-mediated tumor response after Stereotactic Body Radiation
Therapy(SBRT) of a metastatic site in metastatic esophageal cancer patients.
2. To induce the efficacy (effectiveness) of a new combination of therapy, SBRT and
thymalfasin for heavily pretreated, metastatic esophageal cancer patients; Eligible are
patients with metastatic esphageal cancer who have achieved stable disease or have
disease progression after systemic therapy (surgery or definitive chemoradiotherapy) and
have at least two measurable sites of metastatic lesions. Extent of metastatic disease
is recorded both at CT and PET/CT scanning. Radiation is given during combined therapy
to one of the lesions, 25Gy in 5 fractions over one week interval with SBRT, conformally
to maximally spare normal tissue or organ. Thymalfasin treatment is given twice a week
with an interval of 3-4 days each week for a total of 8 weeks. Tumor response is
evaluated by assessing clinical and CT/MRI response for all of the measurable metastatic
sites. A Phase II clinical trial based on an optimum two-stage Phase II Simon design is
used to conduct this pilot study. Ten patients will be treated in Stage one; if there
are no tumor responses, the trial will be terminated. If there are one or more tumor
responses in Stage One, the trial will proceed to enroll an additional 19 patients.
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