Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer - Full Text View

Purpose

The purpose of this study is to show if the adoptive cellular therapy with autologous dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent chemoradiation could improve the quality of life of the patients with locally advanced esophageal cancer, compared with concurrent chemoradiation only.

Condition	Intervention
Esophageal Carcinoma	Other: concurrent chemoradiotherapy plus DC-CIK immunotherapy Other: Concurrent chemoradiation only


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Esophageal Cancer

Genetic and Rare Diseases Information Center resources: Esophageal Cancer

U.S. FDA Resources

Further study details as provided by Capital Medical University:

Primary Outcome Measures:

the quality of life [ Time Frame: initial assessment, months 1, 3, 6 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Other Outcome Measures:

Immunological assessment [ Time Frame: baseline, months 1, 3, 6 and 12 ] [ Designated as safety issue: No ]
Cytokine secretion and T cell populations are assessed.


Estimated Enrollment:	50
Study Start Date:	September 2012
Estimated Study Completion Date:	September 2017
Estimated Primary Completion Date:	September 2016 (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.

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)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691625

Contacts


Contact: Jun Ren, MD, PhD	86-10-63926317	renjun9688@yahoo.com

Locations


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

Sponsors and Collaborators

Capital Medical University

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:	January 27, 2016
Health Authority:	China: Beijing Municipal Health Bureau

Keywords provided by 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 September 23, 2016