RadiotherapyNCT03061162
Pulsed Low Dose Rate Radiation Therapy for Gastric Cancer Patients With Peritoneal Metastasis
A study testing pulsed low dose rate radiation therapy in people with Radiotherapy and Radiotherapy Side Effect, run by Yang Yang at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy, Radiotherapy Side Effect, Stomach Neoplasms
- What is being tested?
- pulsed low dose rate radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Comprehensive Cancer Center of Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Yang Yang, MD,PhD,MSCR, 0086-18602568379, wing_young7@hotmail.com
Jing Yan, MD, 0086-15805182426, firefreebird@163.com
About this study
Official title: Phase II Study of Pulsed Low Dose Rate Radiation Therapy for 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.
Read the 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.
- Conditions
- Radiotherapy, Radiotherapy Side Effect, Stomach Neoplasms
- Being tested
- pulsed low dose rate radiation therapy
- Medical subject headings
- Radiation Injuries, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed low dose rate radiation therapyRadiation
Pulsed low dose rate 3-dimensional conformal radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: pulsed low dose rate radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days
Secondary outcomes (4)
Objective response
Objective response of the target tumor were assessed using the Response Evaluation Criteria in Solid Tumor (RESICT) 1.1 criteria.
Measured: Up to 30 days
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.
Measured: 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.
Measured: Up to 3 years
Time to progression
Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Mar 2017
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yang Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Yang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yang Yang, MD,PhD,MSCR, Principal investigator, The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Medical School of Nanjing University and Clinical Cancer Institute of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061162
- Sponsor's protocol ID
- PLDR-RT-GC
- Status last verified
- Jun 2017
- First submitted
- 17 Feb 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29306203
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pulsed Low Dose Rate Radiation Therapy for Gastric Cancer Patients With Peritoneal Metastasis
- ClinicalTrials.gov ID
- NCT03061162
- Acronym / sponsor ID
- PLDR-RT-GC
- Conditions
- Radiotherapy, Radiotherapy Side Effect, Stomach Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yang YangUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Radiation: pulsed low dose rate radiation therapyGastric 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulsed low dose rate radiation therapyPulsed low dose rate 3-dimensional conformal radiation therapy | Radiation | Study Arm |
Primary outcome
Side effects of pulsed low dose rate radiation therapy
Time frame: Up to 30 days
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.
4 secondary outcomes
Objective response
Time frame: Up to 30 days
Palliative efficacy in terms of quality of life and pain levels
Time frame: Up to 3 years
Duration of response
Time frame: Up to 3 years
Time to progression
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Derived from this study: PubMed 29306203Yan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Yang, MD,PhD,MSCR principal investigator
The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Medical School of Nanjing University and Clinical Cancer Institute of Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed low dose rate radiation therapy in people with Radiotherapy and Radiotherapy Side Effect, run by Yang Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Yang, MD,PhD,MSCR (0086-18602568379, wing_young7@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effects of pulsed low dose rate radiation therapy (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.