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

National University Health System (NUHS)

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer

Treatments: Radiation: Palliative Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01341756

B/09/134

Details and patient eligibility

About

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.

Full 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%

Enrollment: 63 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Radiotherapy for gastric cancer

Experimental group

Description:

Single arm study

Treatment:

Radiation: Palliative Radiotherapy