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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Capital Medical University
Sponsor:
Information provided by (Responsible Party):
Jun Ren MD, PhD, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01691625
First received: September 17, 2012
Last updated: July 22, 2013
Last verified: July 2013
  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

Resource links provided by NLM:


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.


  Eligibility

Ages Eligible for Study:   18 Years and older
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

No publications provided

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: July 22, 2013
Health Authority: China:State Food and Drug Administraion

Keywords provided by Capital Medical University:
Locally advanced esophageal carcinoma
DC-CIK
Immunotherapy

Additional relevant MeSH terms:
Carcinoma
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 20, 2014