Hemithoracic Arc Radiotherapy Post Pleural Decortication
ConditionMalignant Pleural Mesothelioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University
About this trial
Malignant Pleural Mesothelioma is an aggressive and refractory disease , the most aggressive treatment plan offered to these patients include trimodalitiy approach with chemotherapy as the mainstay of treatment . the rationale of post operative Radiotherapy is to sterilize the post operative volume to reduce local failure meanwhile minimizing toxicities in this trial we are going to assess the safety and efficacy of Radiotherapy in Mesothelioma patients poat Pleural decortication
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Evidence of metastatic disease.
Underwent Pleural decortication.
Able to provide informed consent.
Disqualifiers
Poor pulmonary function tests.
Recurrent or palliative cases.
Inability to attend full course of Radiotherapy or follow up visits.
Trial design
Design model
Single group
Treatments tested in this trial
hemithoracic Volumetric Arc Radiotherapy post Pleural decortication
Radiationpost operative delivery of hemithoracic Volumetric Arc Radiotherapy
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: single arm receiving postoperative radiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute Radiation Toxicity
Questionnaire based Follow up about acute Radiation toxicity according to RTOG including dysnea , cough , chest pain , dysnea on effort from grade 1-5
Time frame
weekly assessment during radiation course and monthly follow up for the first 6 months2
late radiation toxicity
follow up of patients using both Questionnaire and performing pulmonary function tests and Echo , focusing on DLCO \& FEV1
Time frame
Bi-monthly fashion of minimum 6 months post radiation courseSponsors and contacts
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Source ClinicalTrials.gov