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

NCT01341756 | Unknown Phase 2 DMC

• 1 other identifier: B/09/134
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; Radiotherapy; palliation; bleeding; pain; obstruction

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Number of patients who develop anorexia, nausea, vomiting as per common toxicity criteria v3.0

  within the first 14 days from start of radiotherapy

Study Arms (1)

Radiotherapy for gastric cancer

EXPERIMENTAL

Single arm study

Radiation: Palliative Radiotherapy

Interventions

Palliative Radiotherapy RADIATION

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

Also known as: palliation, radiotherapy

Radiotherapy for gastric cancer

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients treated with radical intent
• Previous abdominal radiotherapy
• Patients on chemotherapy

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Tan Tock Seng Hospital: collaborator

Study Sites (1)

National University Hospital

Singapore, Singapore, Singapore

RECRUITING

Related Publications (1)

• 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.

  PMID: 30790469 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Hemorrhage; Pain; Bites and Stings

Interventions

Palliative Care; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jeremy Tey, FRANZCR

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy Tey, FRANZCR

CONTACT

+65 67724869; jeremy_tey@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 18, 2011
• First Posted: April 26, 2011
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2012
• Last Updated: May 9, 2011

Record last verified: 2011-04

Locations

SG (1)