Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer
This study is currently recruiting participants.
Verified September 2012 by Capital Medical University
Sponsor:
Capital Medical University
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013