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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01341756

Enrollment

Registered

2011-04-26

Start date

2009-07-31

Completion date

2012-07-31

Last updated

2011-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Gastric Cancer, Radiotherapy, palliation, bleeding, pain, obstruction

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%

Interventions

RADIATIONPalliative Radiotherapy

Palliative Radiotherapy to a total dose of 36Gy in 12 fractions

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Singapore

Contacts

Primary ContactJeremy Tey, FRANZCR

jeremy_tey@nuhs.edu.sg+65 67724869

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026