NCT00006231

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if radiation therapy is effective in preventing metastatic cancer following surgery. PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing metastatic cancer in patients who have undergone diagnostic procedures to identify malignant mesothelioma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 1998

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1998

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 19, 2013

Status Verified

October 1, 2000

First QC Date

September 11, 2000

Last Update Submit

December 18, 2013

Conditions

Malignant MesotheliomaPerioperative/Postoperative Complications

Keywords

localized malignant mesotheliomaadvanced malignant mesotheliomaperioperative/postoperative complications

Outcome Measures

Primary Outcomes (1)

  • Incidence of metastatic skin nodules

Interventions

quality-of-life assessmentPROCEDURE
standard follow-up carePROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven malignant pleural mesothelioma by chest drain insertion, pleural aspiration, pleural biopsy, and/or thoracoscopy within the past 3 weeks PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Not specified Life expectancy: * At least 3 months Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior systemic chemotherapy for malignant mesothelioma Endocrine therapy: * Not specified Radiotherapy: * No prior local radiotherapy for malignant mesothelioma Surgery: * See Disease Characteristics * No other invasive procedures to the same chest site during and for 1 year after study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

West of Scotland Cancer Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Gartnavel General Hospitall

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Stobhill General Hospital

Glasgow, Scotland, G21 3UW, United Kingdom

Location

Related Publications (1)

  • O'Rourke N, Paul J, Hill J: Radiotherapy to mesothelioma drain sites may not be worthwhile: interim report of a randomized study. Lung Cancer 29(1 Suppl 1): A-568, 168, 2000.

    RESULT

MeSH Terms

Conditions

Mesothelioma, MalignantPostoperative Complications

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Noelle O'Rourke, MD

    University of Glasgow

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2000

First Posted

January 27, 2003

Study Start

February 1, 1998

Study Completion

December 1, 2002

Last Updated

December 19, 2013

Record last verified: 2000-10

Locations

GB(3)