Clinical trial NCT03061162: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Radiotherapy
Radiotherapy Side Effect
Stomach Neoplasms
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Side effects of pulsed low dose rate radiation therapy
timeFrame: Up to 30 days
Secondary outcomes:
measure: Objective response
timeFrame: Up to 30 days
measure: Palliative efficacy in terms of quality of life and pain levels
timeFrame: Up to 3 years
measure: Duration of response
timeFrame: Up to 3 years
measure: Time to progression
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Comprehensive Cancer Center of Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Medical School of Nanjing University and Clinical Cancer Institute of Nanjing University
name: Yang Yang, MD,PhD,MSCR
role: PRINCIPAL_INVESTIGATOR
References:
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.