Testing the Addition of Targeted Radiation Therapy to Surgery and the Usual Chemotherapy Treatmen… (NCT04158141) | Clinical Trial Compass
TerminatedPhase 3
Testing the Addition of Targeted Radiation Therapy to Surgery and the Usual Chemotherapy Treatment (Pemetrexed and Cisplatin [or Carboplatin]) for Stage I-IIIA Malignant Pleural Mesothelioma
Stopped: Permanent Administrative Closure
United States16 participantsStarted 2020-01-29
Plain-language summary
This trial studies how well the addition of targeted radiation therapy to surgery and the usual chemotherapy treatment works for the treatment of stage I-IIIA malignant pleural mesothelioma. Targeted radiation therapy such as intensity-modulated radiation therapy or pencil beam scanning uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving targeted radiation therapy in addition to surgery and chemotherapy may work better than surgery and chemotherapy alone for the treatment of malignant pleural mesothelioma.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
PRIOR TO STEP 1 REGISTRATION - ALL PATIENTS
* Pathologically (histologically or cytologically) confirmed diagnosis of epithelioid or biphasic malignant pleural mesothelioma (MPM)
* Imaging proof of clinical stage (American Joint Committee on Cancer \[AJCC\] 8th edition) I-IIIA MPM by PET/CT;
* Diagnostic volumetric CT scan of the chest is preferred; however, the CT portion of the PET/CT may be used if CT imaging is of diagnostic quality
* MPM is amenable to resection by P/D as determined by a thoracic surgeon
* History/physical examination within 42 days prior to Step 1 Registration
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 within 42 days prior to Step 1 Registration
* Required Initial Laboratory Values prior to study entry (must be at least 14 days after last infusion of pre-study entry neoadjuvant therapy, if given):
* Absolute neutrophil count ≥1500 cells/mm3;
* Platelets ≥100,000 cells/mm3;
* Hemoglobin ≥ 8.0 g/dL;
* Serum total bilirubin ≤ 1.5 X ULN (upper limit of normal);
* Aspartate transferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) and alanine transaminase (ALT) (serum glutamic-oxaloacetic transaminase (SGPT)) ≤ 3.0 X ULN;
* Creatinine clearance ≥45 mL/min by the Cockcroft-Gault (C-G) equation
* Negative serum pregnancy test within 14 days of Step 1 Registration for women of childbearing potential
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load wit…
What they're measuring
1
Overall Survival (OS)
Timeframe: Randomization to the date of death or last follow-up. Maximum follow-up time from randomization was 25 months.