Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Capital Medical University
Sponsor:
Information provided by (Responsible Party):
Jun Ren MD, PhD, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01691664
First received: September 18, 2012
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

Cytokine-induced killer (CIK) cells show cytolytic activity against tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining Radiation therapy with adoptive cellular therapy after surgery may be more effective than uses radiation therapy alone in treating esophageal cancer.


Condition Intervention
Esophageal Cancer
Radiation: Only radiation therapy
Other: Radiation therapy plus DC-CIK cellular therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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:
  • Disease free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: Initial assessment → months 1,3,6 and 12 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Immunological assessment [ Time Frame: Initial assessment, months 1,3,6and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Only radiation therapy
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 50Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Radiation: Only radiation therapy
Patients only radiation therapy after surgery
Experimental: Radiation therapy plus DC-CIK cellular therapy

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 50Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.

DC-CIK cellular therapy:Mononuclear cells were collected aseptically with blood cell separator composition apheresis 3 days before radiation, and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times between the radiation intermittent period.

Other: Radiation therapy plus DC-CIK cellular therapy
Patients receive radiation therapy plus DC-CIK cellular therapy after surgery

  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 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
  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: NCT01691664

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

Locations
China, Beijing
Beijing Shijitan Hospital Recruiting
Beijing, Beijing, China, 100038
Contact: Jun Ren, MD, PhD    86-10-63926317      
Sponsors and Collaborators
Capital Medical University
Investigators
Principal Investigator: Jun Ren, MD, PhD Capital Medical University Cancer Center
  More Information

No publications provided

Responsible Party: Jun Ren MD, PhD, Director, Capital Medical University Cancer Center, Capital Medical University
ClinicalTrials.gov Identifier: NCT01691664     History of Changes
Other Study ID Numbers: JR-02
Study First Received: September 18, 2012
Last Updated: September 20, 2012
Health Authority: China: Beijing Municipal Bureau of Health

Keywords provided by Capital Medical University:
Esophageal Cancer
DC-CIK
immunotherapy
cellular therapy
radiation therapy

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 23, 2014