Gastric CancerPhase 2NCT01341756
Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial
A Phase 2 study testing Palliative Radiotherapy in people with Gastric Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Palliative Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2009to Jul 2012
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven adenocarcinoma of the stomach
- Treated with palliative intent
- At least one index symptom such as bleeding, obstruction or pain
- No prior abdominal radiotherapy
- Not on chemotherapy
Who cannot join
- Patients treated with radical intent
- Previous abdominal radiotherapy
- Patients on chemotherapy
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, Singapore
Jeremy Tey, FRANZCR, +65 67724869, jeremy_Tey@nuhs.edu.sg
Jeremy Tey, FRANZCR
About this study
The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls.
Read the detailed description
The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls. (Tey et al.) With this dose fractionation is used for bleeding, there is an increase in response rates from 55%(historical) to 75%for pain, there is an increase in response rates from 25% (historical) to 45% for obstruction, there is an increase in response rates from 25% (historical) to 45%
- Conditions
- Gastric Cancer
- Being tested
- Palliative Radiotherapy
- Keywords
- Gastric Cancer, Radiotherapy, palliation, bleeding, pain, obstruction
- Medical subject headings
- Stomach Neoplasms, Hemorrhage, Pain, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative RadiotherapyRadiation
Also called palliation, radiotherapy
Palliative Radiotherapy to a total dose of 36Gy in 12 fractions
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy for gastric cancer | Experimental | Single arm study Receives: Radiation: Palliative Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of bleeding to radiotherapy
Percentage of patients who do not require blood transfusion after radiotherapy
Measured: At the 12th fraction of radiotherapy and at one month post radiotherapy
Secondary outcomes (1)
Number of patients who develop anorexia, nausea, vomiting as per common toxicity criteria v3.0
Toxicity
Measured: within the first 14 days from start of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startJul 2009
- Primary completionJul 2011 (estimated)
- Study completionJul 2012 (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 Gastric CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Tan Tock Seng Hospital
- Investigators
- Jeremy Tey, FRANZCR, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341756
- Sponsor's protocol ID
- B/09/134
- Status last verified
- Apr 2011
- First submitted
- 18 Apr 2011
- Last updated
- 9 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tey J, Zheng H, Soon YY, Leong CN, Koh WY, Lim K, So JBY, Shabbir A, Tham IWK, Lu J. Palliative radiotherapy in symptomatic locally advanced gastric cancer: A phase II trial. Cancer Med. 2019 Apr;8(4):1447-1458. doi: 10.1002/cam4.2021. Epub 2019 Feb 20.
PubMed 30790469
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial
- ClinicalTrials.gov ID
- NCT01341756
- Acronym / sponsor ID
- B/09/134
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Radiotherapy, palliation, bleeding, pain, obstruction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Tan Tock Seng Hospital
- Study start
- Jul 2009
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 26 Apr 2011 (estimated)
- 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.
The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls.
Detailed description
The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls. (Tey et al.) With this dose fractionation is used for bleeding, there is an increase in response rates from 55%(historical) to 75%for pain, there is an increase in response rates from 25% (historical) to 45% for obstruction, there is an increase in response rates from 25% (historical) to 45%
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy for gastric cancer | Experimental | Radiation: Palliative RadiotherapySingle arm study |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Biopsy proven adenocarcinoma of the stomach
- Treated with palliative intent
- At least one index symptom such as bleeding, obstruction or pain
- No prior abdominal radiotherapy
- Not on chemotherapy
Key exclusion criteria (3 listed)
- Patients treated with radical intent
- Previous abdominal radiotherapy
- Patients on chemotherapy
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 |
|---|---|---|
| Palliative RadiotherapyAlso: palliation, radiotherapyPalliative Radiotherapy to a total dose of 36Gy in 12 fractions | Radiation | Radiotherapy for gastric cancer |
Primary outcome
Response of bleeding to radiotherapy
Time frame: At the 12th fraction of radiotherapy and at one month post radiotherapy
Percentage of patients who do not require blood transfusion after radiotherapy
1 secondary outcome
Number of patients who develop anorexia, nausea, vomiting as per common toxicity criteria v3.0
Time frame: within the first 14 days from start of radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2011.
- Derived from this study: PubMed 30790469Tey J, Zheng H, Soon YY, Leong CN, Koh WY, Lim K, So JBY, Shabbir A, Tham IWK, Lu J. Palliative radiotherapy in symptomatic locally advanced gastric cancer: A phase II trial. Cancer Med. 2019 Apr;8(4):1447-1458. doi: 10.1002/cam4.2021. Epub 2019 Feb 20.
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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.
Jeremy Tey, FRANZCR principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palliative Radiotherapy in people with Gastric Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
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 5 inclusion and 3 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 9 May 2011. 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 Singapore. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jeremy Tey, FRANZCR (+65 67724869, jeremy_tey@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of bleeding to radiotherapy (time frame: At the 12th fraction of radiotherapy and at one month post radiotherapy). 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 NCT01341756, 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 9 May 2011.