Combination Chemotherapy Before Surgery in Treating Patients With Mesothelioma of the Lung

Phase 2

Completed

• Conditions: Malignant Mesothelioma

• Registration Number: NCT00030745
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have mesothelioma of the lung.

Detailed Description

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.

Study Timeline

• Study Start: 2000-06
• Study First Submitted: 2002-02-14
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-05
• Study Completion: 2003-08
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-14
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

UniversitaetsSpital; 🇨🇭 Zurich, Switzerland