Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SWS-SAKK-17/04 | |||
| EU-20615 | |||
| 2006-000445-19 | EudraCT Number | ||
| LILLY-SAKK-17/04 | Other Identifier | SAKK | |
| CDR0000481153 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized phase II trial is studying how well giving pemetrexed disodium together with cisplatin followed by surgery with or without radiation therapy works in treating patients with malignant pleural mesothelioma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, histology (sarcomatous or other vs epithelial or mixed histology), nodal status (N0-1 vs N2), and extent of disease (T1-2 vs T3).
Part 1 (neoadjuvant therapy and surgery): Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Within 8 weeks after completion of neoadjuvant therapy, patients without progressive disease undergo extrapleural pneumonectomy.
Part 2 : Patients achieving R0 or R1 resection proceed to part 2 of study treatment and are randomized to 1 of 2 treatment arms. Patients with R2 resection, disease progression, or symptomatic deterioration after treatment in part 1 are taken off study.
Patients undergo blood and tissue collection at registration and surgery for laboratory and biomarker analysis.
After completion of study treatment, patients are followed periodically for up to 5 years after surgery.
PROJECTED ACCRUAL: A total of 155 patients will be accrued for this study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No radiotherapy | Active Comparator |
| |
| Radiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Cisplatin 75 mg/m2 i.v. over approximately 2 hours on day 1 every 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete macroscopic resection (part 1) | After surgery (15 weeks after trial registration) | |
| Loco-regional relapse-free survival (part 2) | From surgery until the first occurrence of loco-regional relapse |
| Measure | Description | Time Frame |
|---|---|---|
| Response to neoadjuvant therapy (part 1) | Every 6 months in the follow-up until death for a maximum of 5 years | |
| Adverse drug reaction to neoadjuvant therapy (part 1) | According to CTCAE | |
Not provided
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant pleural mesothelioma
No obvious invasion of mediastinal structures by CT scan (e.g., heart, aorta, spine, esophagus)
No obvious widespread chest wall invasion
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rolf A. Stahel, Prof | UniversitaetsSpital Zuerich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | D-79106 | Germany | |||
| Kantonsspital Aarau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26538423 | Result | Stahel RA, Riesterer O, Xyrafas A, Opitz I, Beyeler M, Ochsenbein A, Fruh M, Cathomas R, Nackaerts K, Peters S, Mamot C, Zippelius A, Mordasini C, Caspar CB, Eckhardt K, Schmid RA, Aebersold DM, Gautschi O, Nagel W, Topfer M, Krayenbuehl J, Ribi K, Ciernik IF, Weder W. Neoadjuvant chemotherapy and extrapleural pneumonectomy of malignant pleural mesothelioma with or without hemithoracic radiotherapy (SAKK 17/04): a randomised, international, multicentre phase 2 trial. Lancet Oncol. 2015 Dec;16(16):1651-8. doi: 10.1016/S1470-2045(15)00208-9. Epub 2015 Nov 2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pemetrexed | Drug | Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 every 21 days |
|
| Therapeutic conventional surgery | Procedure | Extrapleural pneumonectomy |
|
| Radiotherapy | Radiation | CTV1 will receive 45 or 46 Gy. CTV2 will be treated up to a total dose of 55,9 to 56,2 Gy. |
|
| Operability (part 1) |
| Proportion of patients remaining operable after completing chemotherapy (9 weeks after trial registration) |
| Surgical complications (part 1) | Within 3 month after surgery |
| Reasons for non-randomization (part 1) | Reasons for non-randomization include macroscopic incomplete resection, patients' refusal or patient can not be subjected to RT within 10 weeks after surgery. |
| Relapse-free or progression-free survival (part 1) | From registration until progression/relapse (loco-regional or distant) or death |
| Adverse reaction to postoperative radiotherapy (part 2) | According to CTCAE |
| Late toxicity (part 2) | Late toxicities occurring later than 6 weeks after the last RT fraction |
| Feasibility of postoperative radiotherapy (part 2) | Proportion of patients receiving at least 90% of planned RT dose |
| Relapse-free survival (part 2) | From registration until progression/relapse (loco-regional or distant) or death |
| Psychological distress (quality of life) (part 2) | Until 22 weeks after treatment termination |
| Overall survival | From registration until death for all registered patients, and from randomization to death for all randomized patients. |
| Aarau |
| CH-5001 |
| Switzerland |
| Kantonsspital Baden | Baden | CH-5404 | Switzerland |
| Universitaetsspital-Basel | Basel | CH-4031 | Switzerland |
| Spital Tiefenau | Bern | 3004 | Switzerland |
| Inselspital Bern | Bern | CH-3010 | Switzerland |
| Kantonsspital Bruderholz | Bruderholz | CH-4101 | Switzerland |
| Kantonsspital Graubuenden | Chur | CH-7000 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| Kantonsspital Olten | Olten | CH-4600 | Switzerland |
| Kantonsspital - St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| SpitalSTS AG Simmental-Thun-Saanenland | Thun | 3600 | Switzerland |
| UniversitaetsSpital Zuerich | Zurich | CH-8091 | Switzerland |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| D054363 | Solitary Fibrous Tumor, Pleural |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D054364 | Solitary Fibrous Tumors |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000068437 | Pemetrexed |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D013812 | Therapeutics |
Not provided
Not provided