Radiation Therapy in Preventing Metastatic Cancer in Patients Who Have Diagnostic Procedures to Identify Malignant Mesothelioma

A Randomized Study to Assess Whether Radiotherapy Prevents Skin Lumps at Sites Where Needles or Tubes Have Been Inserted in Patients With Malignant Mesothelioma

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00006231

Enrollment

Registered

2003-01-27

Start date

1998-02-28

Completion date

2002-12-31

Last updated

2013-12-19

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

Conditions

Malignant Mesothelioma, Perioperative/Postoperative Complications

Keywords

localized malignant mesothelioma, advanced malignant mesothelioma, perioperative/postoperative complications

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.

Detailed description

OBJECTIVES: * Determine the efficacy of radiotherapy in the prevention of metastatic skin nodules or tumor seeding following invasive diagnostic procedures, such as chest drain insertion, pleural aspiration, pleural biopsy, and thoracoscopy, in patients with malignant mesothelioma. * Determine whether the nodules that develop after radiotherapy are symptomatic in these patients. * Compare the quality of life of patients treated with radiotherapy vs standard care alone. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive radiotherapy on 3 consecutive days beginning within 3 weeks after chest drain insertion, pleural aspiration, pleural biopsy, or thoracoscopy and once the wounds have healed. * Arm II: Patients receive standard supportive care alone. Quality of life is assessed at baseline, and then at 1, 2, 4, 6, 9, and 12 months. Patients are followed at 1, 2, 4, 6, 9, and 12 months. PROJECTED ACCRUAL: A total of 44 patients (22 per arm) will be accrued for this study within 2 years.

Interventions

PROCEDUREquality-of-life assessment

PROCEDUREstandard follow-up care

RADIATIONradiation therapy

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Incidence of metastatic skin nodules	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026