A Feasibility Study Evaluating Surgery for Mesothelioma After Radiation Therapy Using Extensive Pleural Resection (SMARTER)

Primary Outcome Measures Maximum Tolerated Dose for Background Radiation [ Time Frame: Up to five years ]AEs will be graded by CTCAE. Maximum tolerated dose is the dose level that do not result in fatal lung injury (grade 5 lung toxicity) or life-threatening or fatal treatment related toxicity (grade 4+). Secondary Outcome Measures Patient morbidity [ Time Frame: Up to five years ]NCI more

Primary Outcome Measures

  1. Maximum Tolerated Dose for Background Radiation [ Time Frame: Up to five years ]AEs will be graded by CTCAE. Maximum tolerated dose is the dose level that do not result in fatal lung injury (grade 5 lung toxicity) or life-threatening or fatal treatment related toxicity (grade 4+).

Secondary Outcome Measures

  1. Patient morbidity [ Time Frame: Up to five years ]NCI common toxicity scale
  2. Local recurrence [ Time Frame: Up to five years ]Documented radiographically
  3. Patients’ quality of life [ Time Frame: Up to five years ]Short Form Health Survey-36 (SF-36) Form
  4. Evaluating patients’ pain [ Time Frame: Up to five years ]Assess by using the Short Form (BPI-SF)
  5. Evaluating patients’ pain [ Time Frame: Up to five years ]Assess by using The Hospital Anxiety and Depression Scale (HADS)
  6. Evaluating patients’ pain [ Time Frame: Up to five years ]Assess by using the EuroQol EQ-5D-5L Questionnaire
  7. Evaluating patients’ pain [ Time Frame: Up to five years ]Assess by using the Sensitivity to Pain Traumatization Scale (SPTS)
  8. Evaluating patients’ pain [ Time Frame: Up to five years ]Assess by using the ID Pain form
  9. Evaluating patients’ pain [ Time Frame: Up to five years ]Assess by using the Pain Catastrophizing Scale (PCS)
  10. Evaluating patients’ pain [ Time Frame: Up to five years ]Assess by using the Post-traumatic Stress Disorder Checklist-Civilian version (PCL-C)
  11. Evaluating patients’ pain [ Time Frame: Up to five years ]Assess by using a variety of standard instruments including the Injustice Experience Questionnaire (IEQ).

Inclusion Criteria

  • Age ≥ 18 years
  • Eastern Cooperative oncology Group (ECOG) performance status of 0-2
  • Good pulmonary function precluding radiation therapy (FEV1>1 L or >40% predicted or DLCO >45% predicted)
  • Any patient with a new histological diagnosis of malignant pleural mesothelioma (MPM). Sarcomatoid or biphasic histologies can be included but will be analyzed separately due to their poor prognosis.
  • Stage T1-3 N0-1 M0 according to the 8th edition of the tumor, node, and metastases (TNM) staging system based on conventional investigations and tests (Appendix 1). Note that the updated TNM staging system now categorizes ipsilateral mediastinal nodes as N1 disease.
  • Suitable for combined modality therapy
  • informed consent.

Exclusion Criteria

  • Age < 18 years.
  • Contralateral mediastinal nodal disease (N2)
  • Distant metastatic disease (M1).
  • Poor performance status ECOG 3-4.
  • Poor pulmonary function precluding radiation therapy (FEV1<1 L or <40% predicted or diffusion lung capacity for carbon monoxide (DLCO) <45% predicted)
  • Failure to provide informed consent.
  • Previous thoracic irradiation.
  • Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
  • Previous chemotherapy for this or concurrent malignancy.
  • Previous or concomitant malignancies except for patients with non-melanoma skin cancer, contralateral non-invasive breast cancer, prostate cancer treated with curative intent or carcinoma in situ of any other site. In addition, patients with invasive cancers treated more than 3 years previously and without evidence of recurrence will be eligible.
  • Women who are currently pregnant or lactating.

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Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: September 27th, 2019.

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Last update: May 07, 2019. 08:38:48 pm.