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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Esophageal Cancer	Radiation: Only radiation therapy; Other: Radiation therapy plus DC-CIK cellular therapy	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Adoptive Cellular Therapy and Radiation Therapy After Surgery in Treating Patients With Esophageal Cancer
Study Start Date :	September 2012
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	June 2019

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Disease free survival [ Time Frame: 4 years ]

Secondary Outcome Measures :

1. quality of life [ Time Frame: Initial assessment → months 1,3,6 and 12 ]

Other Outcome Measures:

1. Immunological assessment [ Time Frame: Initial assessment, months 1,3,6and 12 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	September 25, 2012
Last Update Posted:	February 7, 2017
Last Verified:	February 2017

Keywords provided by Jun Ren MD, PhD, 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