Pulsed Low Dose Rate Radiation Therapy for Gastric Cancer Patients With Peritoneal Metastasis

Stomach Neoplasms Clinical Trial

Official title:

Phase II Study of Pulsed Low Dose Rate Radiation Therapy for Gastric Cancer Patients With Peritoneal Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03061162
• Other study ID #: PLDR-RT-GC
• Status: Recruiting
• Phase: N/A
• First received: February 17, 2017
• Last updated: June 13, 2017
• Start date: March 1, 2017
• Est. completion date: March 1, 2022

Study information

• Verified date: June 2017
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Yang Yang, MD,PhD,MSCR
• Phone: 0086-18602568379
• Email: wing_young7[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have histologically-confirmed gastric adenocarcinoma

• 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:

• Patients who have had chemotherapy or radiotherapy to the reirradiation target within 4 weeks prior to entering the study

• 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

Related Conditions & MeSH terms

• Radiotherapy
• Radiotherapy Side Effect
• Stomach Neoplasms

Intervention

Radiation:
• pulsed low dose rate radiation therapy
Pulsed low dose rate 3-dimensional conformal radiation therapy

Locations

Country	Name	City	State
China	The Comprehensive Cancer Center of Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yang Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Palliative efficacy in terms of quality of life and pain levels	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
Secondary	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
Secondary	Time to progression	Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves.	Up to 3 years