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N/A
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer

Thank you

Trial Information


Inclusion Criteria:



- cytologically or histologically confirmed esophageal carcinoma

- Tumor extension beyond muscularis propria and/or nodal involvement without evidence
of M1 disease

- Prior en bloc resection, with curative intent, of all known tumor

- No metastatic disease

- Age: > 18

- Karnofsky performance status ≥ 70

- At least 3 weeks since prior surgery

- Normal functions of heart, lung, liver, kidney and bone marrow

- Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl,
neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL

- All patients must be evaluated by a radiation oncologist prior to enrollment to
ensure patient is appropriate for radiotherapy

- Informed consent signed

Exclusion Criteria:

- Patients with metastatic disease.

- Patients who are pregnant or nursing.

- Patients with poor bone marrow, liver and kidney functions, which would make
radiation therapy intolerable

- Patients with contraindication for irradiation: complete obstruction of esophagus,
deep esophageal ulcer, fistula to mediastinum, or haematemesis

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Jun Ren, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Capital Medical University Cancer Center

Authority:

China: Beijing Municipal Bureau of Health

Study ID:

JR-02

NCT ID:

NCT01691664

Start Date:

September 2012

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Esophageal Cancer
  • DC-CIK
  • immunotherapy
  • cellular therapy
  • radiation therapy
  • Esophageal Diseases
  • Esophageal Neoplasms

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