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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

cisplatin

gemcitabine hydrochloride

conventional surgery

About this trial

This is an interventional treatment trial for Malignant Mesothelioma focused on measuring stage IA malignant mesothelioma, stage IB malignant mesothelioma, stage II malignant mesothelioma, stage III malignant mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UniversitaetsSpital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00030745

First Posted

February 14, 2002

Last Updated

May 14, 2012

Sponsor

Swiss Group for Clinical Cancer Research

1. Study Identification

Unique Protocol Identification Number

NCT00030745

Brief Title

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

Official Title

Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

June 2000 (undefined)

Primary Completion Date

May 2003 (Actual)

Study Completion Date

August 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Mesothelioma

Keywords

stage IA malignant mesothelioma, stage IB malignant mesothelioma, stage II malignant mesothelioma, stage III malignant mesothelioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

gemcitabine hydrochloride

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rolf A. Stahel, MD

Organizational Affiliation

UniversitaetsSpital Zuerich

Official's Role

Study Chair

Facility Information:

Facility Name

UniversitaetsSpital

City

Zurich

ZIP/Postal Code

CH-8091

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

17429100

Citation

Weder W, Stahel RA, Bernhard J, Bodis S, Vogt P, Ballabeni P, Lardinois D, Betticher D, Schmid R, Stupp R, Ris HB, Jermann M, Mingrone W, Roth AD, Spiliopoulos A; Swiss Group for Clinical Cancer Research. Multicenter trial of neo-adjuvant chemotherapy followed by extrapleural pneumonectomy in malignant pleural mesothelioma. Ann Oncol. 2007 Jul;18(7):1196-202. doi: 10.1093/annonc/mdm093. Epub 2007 Apr 11.

Results Reference

result

Malignant Mesothelioma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial