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This phase II trial studies the side effects and response of pulsed low dose rate radiation therapy in treating gastric cancer patients with peritoneal metastasis.
This phase II trial studies the side effects and response of pulsed low dose rate radiation therapy in treating gastric cancer patients with peritoneal metastasis. Radiation therapy uses pulsed low dose rate high energy X rays to kill tumor cells and make less side effects than conventional 3-dimensional conformal radiation therapy. Palliative radiation therapy may help gastric cancer patients with peritoneal metastasis live more comfortably.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulsed low dose rate radiation therapy | Radiation | Pulsed low dose rate 3-dimensional conformal radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Side effects of pulsed low dose rate radiation therapy | Number of participants with adverse events and the grade of adverse events. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response | Objective response of the target tumor were assessed using the Response Evaluation Criteria in Solid Tumor (RESICT) 1.1 criteria. | Up to 30 days |
| Palliative efficacy in terms of quality of life and pain levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Yang, MD,PhD,MSCR | Contact | 0086-18602568379 | wing_young7@hotmail.com | |
| Jing Yan, MD | Contact | 0086-15805182426 | firefreebird@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yang Yang, MD,PhD,MSCR | The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Medical School of Nanjing University and Clinical Cancer Institute of Nanjing University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Comprehensive Cancer Center of Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29306203 | Derived | 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. |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D006339 | Heart Rate |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Assessed using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 15 Palliative (QLQ-C15-PAL) and the Numeric Pain Scale. The mean and standard deviation will be estimated at each time point.
| Up to 3 years |
| Duration of response | Measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Assessed using the RESICT 1.1 criteria. Estimated using Kaplan-Meier curves. | Up to 3 years |
| Time to progression | Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves. | Up to 3 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006439 |
| Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |