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 January 2016 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: January 27, 2016
Last verified: January 2016
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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 |
| Official Title: | Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer |
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 Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | December 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 (Adult, Senior) |
| 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
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
| 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: | January 27, 2016 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Capital Medical University:
|
Esophageal Cancer DC-CIK immunotherapy cellular therapy radiation therapy |
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