Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura
18 Years
N/A
Both
Malignant Mesothelioma
Trial Information
Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura
OBJECTIVES:
- Determine the proportion of patients with potentially resectable mesothelioma of the
pleura remaining operable after treatment with neoadjuvant cisplatin and gemcitabine.
- Determine the response rate and overall survival of patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
- Determine the number of postoperative hospitalization days and occurrence and duration
of surgical complications in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Compare the proportion of patients who report psychological distress at 3 months after
surgery vs at study registration.
OUTLINE: Patients receive cisplatin IV on day 1 and gemcitabine IV on days 1, 8, and 15.
Treatment repeats every 28 days for 3 courses. Within 6 weeks after completion of
chemotherapy, patients undergo restaging by CT scan followed by surgical resection.
Quality of life is assessed at baseline, day 1 of course 3, within 4 weeks after surgery,
and then at 3 and 6 months.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 61 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically and clinically confirmed pleural mesothelioma
- Stages T1-3, N0-2, M0 by CT scan of the chest
- Mediastinoscopy required for staging of mediastinal lymph nodes
- Considered completely resectable
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- No severe liver disease
Renal:
- Creatinine no greater than 1.7 mg/dL
Cardiac:
- Adequate cardiac function
- No cardiac disease that would preclude forced hydration or surgery
Pulmonary:
- Predicted postoperative FEV_1 greater than 1 by spirometry
Other:
- No contraindication to surgery
- No other prior or concurrent malignancy except adequately treated carcinoma in situ
of the cervix or basal cell or squamous cell skin cancer
- No uncontrolled infection
- No uncontrolled diabetes
- No neurologic or psychiatric disorders that would preclude study compliance
- No other serious illnesses that would preclude study participation
- No other circumstances that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- No prior pleurectomy or lung resection except for diagnostic purposes
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Rolf A. Stahel, MD
Investigator Role:
Study Chair
Investigator Affiliation:
UniversitaetsSpital Zuerich
Authority:
Switzerland: Swissmedic
Study ID:
SAKK 17/00
NCT ID:
NCT00030745
Start Date:
June 2000
Completion Date:
August 2003
Related Keywords:
- Malignant Mesothelioma
- stage IA malignant mesothelioma
- stage IB malignant mesothelioma
- stage II malignant mesothelioma
- stage III malignant mesothelioma
- Mesothelioma
Name | Location |
|---|
