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

NCT03061162 | Unknown

• 1 other identifier: PLDR-RT-GC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiotherapy; Radiotherapy Side Effect; Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Objective response

  Up to 30 days

• Palliative efficacy in terms of quality of life and pain levels

  Up to 3 years

• Duration of response

  Up to 3 years

• Time to progression

  Up to 3 years

Study Arms (1)

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.

Radiation: pulsed low dose rate radiation therapy

Interventions

pulsed low dose rate radiation therapy RADIATION

Pulsed low dose rate 3-dimensional conformal radiation therapy

Study Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yang Yang: lead

Study Sites (1)

The Comprehensive Cancer Center of Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 29306203 DERIVED

MeSH Terms

Conditions

Radiation Injuries; Stomach Neoplasms

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Wounds and Injuries; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• 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

Central Study Contacts

Yang Yang, MD,PhD,MSCR

CONTACT

0086-18602568379; wing_young7@hotmail.com

Jing Yan, MD

CONTACT

0086-15805182426; firefreebird@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 23, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2022
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)