Pulsed Low Dose Rate Radiation Therapy for Gastric Cancer Patients With Peritoneal Metastasis
NCT ID: NCT03061162
Last Updated: 2017-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2017-03-01
2022-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study Arm
Gastric cancer patients with peritoneal metastasis undergo pulsed low dose rate 3-dimensional conformal radiation therapy, QD, 5 days a week for 25 days. Treatment continues in the absence of disease progression or unacceptable toxicity.
pulsed low dose rate radiation therapy
Pulsed low dose rate 3-dimensional conformal radiation therapy
Interventions
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pulsed low dose rate radiation therapy
Pulsed low dose rate 3-dimensional conformal radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Patients must have metastasis tumor located within peritoneal cavity
* Tumor within the irradiated field is negatively impacting patient's quality of life or threatening catastrophic complication if left untreated as determined by the treating physician
* Patient is not a surgical candidate or tumor is not surgically resectable, as documented by surgical oncologist
* Patient is not a candidate for, or has not demonstrated a significant local response to chemotherapy, biologic, or other therapies
* Patients must have measurable disease per Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 in the irradiated field
* Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to radiation simulation, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed
* Eastern Cooperative Oncology Group (ECOG) performance status determined to be between 0 and 3
* Absolute neutrophil count (ANC) \>=1,000/ul
* Platelets (PLT) \>=75,000/ul
* Subjects must sign a written informed consent and Health Insurance Probability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures of assessments and must be willing to comply with treatment and follow-up
Exclusion Criteria
* A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
* Scleroderma or active connective tissue disease
* Active inflammatory bowel disease
* Serious, active infections requiring treatment with intravenous (IV) antibiotics
* Uncontrolled intercurrent illness including, but not limited to, or psychiatric illness/social situations that would limit compliance with study requirements
18 Years
ALL
No
Sponsors
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Yang Yang
OTHER
Responsible Party
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Yang Yang
Principal Investigator
Principal Investigators
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Yang Yang, MD,PhD,MSCR
Role: PRINCIPAL_INVESTIGATOR
The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Medical School of Nanjing University and Clinical Cancer Institute of Nanjing University
Locations
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The Comprehensive Cancer Center of Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Yan J, Yang J, Yang Y, Ren W, Liu J, Gao S, Li S, Kong W, Zhu L, Yang M, Qian X, Liu B. Use of Pulsed Low-Dose Rate Radiotherapy in Refractory Malignancies. Transl Oncol. 2018 Feb;11(1):175-181. doi: 10.1016/j.tranon.2017.12.004. Epub 2018 Jan 4.
Other Identifiers
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PLDR-RT-GC
Identifier Type: -
Identifier Source: org_study_id
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