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Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer
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Purpose
| Condition | Intervention |
|---|---|
| Esophageal Carcinoma | Other: concurrent chemoradiotherapy plus DC-CIK immunotherapy Other: Concurrent chemoradiation only |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer |
- the quality of life [ Time Frame: initial assessment, months 1, 3, 6 and 12 ]
- progression-free survival [ Time Frame: 1 year ]
- Immunological assessment [ Time Frame: baseline, months 1, 3, 6 and 12 ]Cytokine secretion and T cell populations are assessed.
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2019 |
| Estimated Primary Completion Date: | September 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: concurrent chemoradiotherapy plus DC-CIK immunotherapy
patients will receive concurrent chemoradiotherapy plur DC-CIK immunotherapy
|
Other: concurrent chemoradiotherapy plus DC-CIK immunotherapy
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation. DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition apheresis 3 days before concurrent chemoradiation, and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times between the Chemoradiation intermittent period. |
|
Active Comparator: Concurrent chemoradiation only
patients will receive concurrent chemoradiotherapy only
|
Other: Concurrent chemoradiation only
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator. Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation. |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- cytologically or histologically confirmed locally advanced esophageal carcinoma
- Age: > 18
- Karnofsky performance status ≥ 70
- At least one measurable tumor lesions according to the RECIST criteria.
- 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
- Informed consent signed
Exclusion Criteria:
- Patients with metastatic disease in the central nervous system (CNS).
- Patients who are pregnant or nursing.
- Patients with poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable
- Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
- coexisted morbidities that investigators believed not suitable for chemoradiation
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01691625
| Contact: Jun Ren, MD, PhD | 86-10-63926317 | renjun9688@yahoo.com |
| China, Beijing | |
| Capital Medical University Cancer Center | Recruiting |
| Beijing, Beijing, China, 100038 | |
| Contact: Jun Ren, MD, PhD 86-10-63926317 renjun9688@yahoo.com | |
| Principal Investigator: Jun Ren, MD, PhD | |
More Information
| Responsible Party: | Jun Ren MD, PhD, Director,Capital Medical University (CMU)Cancer Center,, Capital Medical University |
| ClinicalTrials.gov Identifier: | NCT01691625 History of Changes |
| Other Study ID Numbers: |
JR-01 |
| Study First Received: | September 17, 2012 |
| Last Updated: | February 3, 2017 |
Keywords provided by Jun Ren MD, PhD, Capital Medical University:
|
Locally advanced esophageal carcinoma DC-CIK Immunotherapy |
Additional relevant MeSH terms:
|
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on July 21, 2017