Malignant MesotheliomaPhase 2NCT00030745
Combination Chemotherapy Before Surgery in Treating Patients With Mesothelioma of the Lung
A Phase 2 study testing cisplatin, gemcitabine hydrochloride and conventional surgery in people with Malignant Mesothelioma, run by Swiss Cancer Institute at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Mesothelioma
- What is being tested?
- cisplatin, gemcitabine hydrochloride and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2000to Aug 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura
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.
Read the 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.
- Conditions
- Malignant Mesothelioma
- Being tested
- cisplatin, gemcitabine hydrochloride, conventional surgery
- Keywords
- stage IA malignant mesothelioma, stage IB malignant mesothelioma, stage II malignant mesothelioma, stage III malignant mesothelioma
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
conventional surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 2000
- Primary completionMay 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rolf A. Stahel, MD, Study chair, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030745
- Sponsor's protocol ID
- SAKK 17/00
- Other IDs
- SWS-SAKK-17-00, EU-20136
- Status last verified
- May 2012
- First submitted
- 14 Feb 2002
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17429100
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Chemotherapy Of Potentially Resectable Mesothelioma Of The Pleura
- ClinicalTrials.gov ID
- NCT00030745
- Acronym / sponsor ID
- SAKK 17/00
- Conditions
- Malignant Mesothelioma
- Keywords
- stage IA malignant mesothelioma, stage IB malignant mesothelioma, stage II malignant mesothelioma, stage III malignant mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- Jun 2000
- Primary completion
- May 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin | Drug | – |
| gemcitabine hydrochloride | Drug | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
- Results publication: PubMed 17429100Weder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf A. Stahel, MD study chair
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin, gemcitabine hydrochloride and conventional surgery in people with Malignant Mesothelioma, run by Swiss Cancer Institute at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00030745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.