Palliative Radiotherapy for Symptomatic Locally Advanced... | NCT01341756

Studies
Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial

NCT01341756

Sponsor

National University Hospital, Singapore

Status

Unknown status

Last Update Posted

May 9, 2011Estimated

Enrollment

63Estimated

Phase

Phase 2

Conditions

Gastric Cancer

Interventions

Palliative Radiotherapy

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Jul 2011Estimated

Completion Date

Jul 2012Estimated

First Submitted Date

Apr 18, 2011

First Submission Date that Met QC Criteria

Apr 24, 2011

First Posted Date

Apr 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2011

Last Update Posted Date

May 9, 2011Estimated

Name	Class
Tan Tock Seng Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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%

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiotherapy for gastric cancer	Experimental	Single arm study	Radiation: Palliative Radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Palliative Radiotherapy	Radiation	Palliative Radiotherapy to a total dose of 36Gy in 12 fractions	Radiotherapy for gastric cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response of bleeding to radiotherapy	Percentage of patients who do not require blood transfusion after radiotherapy	At the 12th fraction of radiotherapy and at one month post radiotherapy

Secondary Outcomes

Measure	Description	Time Frame
Number of patients who develop anorexia, nausea, vomiting as per common toxicity criteria v3.0	Toxicity	within the first 14 days from start of radiotherapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients treated with radical intent
Previous abdominal radiotherapy
Patients on chemotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeremy Tey, FRANZCR	Contact	+65 67724869		jeremy_tey@nuhs.edu.sg

Overall Officials

Name	Affiliation	Role
Jeremy Tey, FRANZCR	National University Hospital, Singapore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National University Hospital	Recruiting	Singapore	Singapore		Singapore

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30790469	Derived	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.

ID	Term
D013274	Stomach Neoplasms
D006470	Hemorrhage
D010146	Pain
D001733	Bites and Stings

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D010166	Palliative Care
D011878	Radiotherapy

ID	Term
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services