Mesothelioma Clinical Trials
Radiation Therapy
in Preventing Metastatic Cancer in Patients Who Have
Diagnostic Procedures to Identify Malignant
Mesothelioma
This study is currently
recruiting patients.
Cancer Research UK
For more information:National
Cancer Institute (NCI)
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.
| Condition |
Treatment or Intervention |
localized malignant
mesothelioma
advanced malignant
mesothelioma
perioperative/postoperative
complications
Quality of Life |
Procedure: complications of
therapy
management
Procedure: quality-of-life
assessment
Procedure: radiation
therapy
Procedure: supportive
care/therapy |
This is a Phase III test
- In Phase III studies, the study drug or treatment is
given to large groups of people (1,000-3,000) to confirm its
effectiveness, monitor side effects, compare it to commonly
used treatments, and collect information that will allow the
drug or treatment to be used safely.
Study Type: Interventional
Study
Design: Treatment
Official Title: Phase III Randomized
Study of Radiotherapy in the Prevention of Metastatic Skin
Nodules Following Invasive Diagnostic Procedures in Patients
With Malignant Mesothelioma
Further Study Details:
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.
Genders Eligible for Study: Both
DISEASE CHARACTERISTICS:
- Histologically proven malignant pleural mesothelioma by
chest drain insertion, pleural aspiration, pleural biopsy,
and/or thoracoscopy within the past 3 weeks
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