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

Primary Purpose

Radiotherapy, Radiotherapy Side Effect, Stomach Neoplasms

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

pulsed low dose rate radiation therapy

About this trial

This is an interventional treatment trial for Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Comprehensive Cancer Center of Nanjing Drum Tower HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Objective response

Objective response of the target tumor were assessed using the Response Evaluation Criteria in Solid Tumor (RESICT) 1.1 criteria.

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.

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.

Time to progression

Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves.

Full Information

NCT ID

NCT03061162

First Posted

February 17, 2017

Last Updated

June 13, 2017

Sponsor

Yang Yang

1. Study Identification

Unique Protocol Identification Number

NCT03061162

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

March 1, 2020 (Anticipated)

Study Completion Date

March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yang Yang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radiotherapy, Radiotherapy Side Effect, Stomach Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study Arm

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

pulsed low dose rate radiation therapy

Intervention Description

Pulsed low dose rate 3-dimensional conformal radiation therapy

Primary Outcome Measure Information:

Title

Side effects of pulsed low dose rate radiation therapy

Description

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.

Time Frame

Up to 30 days

Secondary Outcome Measure Information:

Title

Objective response

Description

Objective response of the target tumor were assessed using the Response Evaluation Criteria in Solid Tumor (RESICT) 1.1 criteria.

Time Frame

Up to 30 days

Title

Palliative efficacy in terms of quality of life and pain levels

Description

Time Frame

Up to 3 years

Title

Duration of response

Description

Time Frame

Up to 3 years

Title

Time to progression

Description

Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves.

Time Frame

Up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yang Yang, MD,PhD,MSCR

Phone

0086-18602568379

wing_young7@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jing Yan, MD

Phone

0086-15805182426

firefreebird@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yang Yang, MD,PhD,MSCR

Organizational Affiliation

The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Medical School of Nanjing University and Clinical Cancer Institute of Nanjing University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Comprehensive Cancer Center of Nanjing Drum Tower Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yang Yang, MD,PhD,MSCR

Phone

0086-18602568379

wing_young7@hotmail.com

First Name & Middle Initial & Last Name & Degree

Jing Yan, MD

Phone

0086-15805182426

firefreebird@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29306203

Citation

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.

Results Reference

derived

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

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