Short Neoadjuvant Hemithoracic IMRT for MPM
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ClinicalTrials.gov Identifier: NCT00797719 |
Recruitment Status :
Active, not recruiting
First Posted : November 25, 2008
Last Update Posted : October 7, 2022
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Condition or disease | Intervention/treatment | Phase |
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Malignant Pleural Mesothelioma | Other: Pre-op RT +/- chemotherapy | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Feasibility Study Evaluating Neoadjuvant Hemithoracic Intensity Modulated Radiation Therapy for Surgically Resectable Malignant Pleural Mesothelioma |
Actual Study Start Date : | October 2008 |
Estimated Primary Completion Date : | January 2023 |
Estimated Study Completion Date : | January 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: All
This is a single arm study. All patients enrolled will be in this arm.
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Other: Pre-op RT +/- chemotherapy
Patients on the study will receive IMRT for approximately 1 week of 5 daily treatments. Short pre-operative hemithoracic RT is a new technique. 1 week post-RT, they will proceed with an extrapleural pneumonectomy. If the mediastinal lymph nodes that are removed during surgery are positive for tumour cells, 3 cycles of chemotherapy, consisting of raltitrexed and cisplatin, will be given 6-12 weeks post-surgery. |
- The primary outcome for the study will be the proportion of patients treated as per protocol without treatment related mortality. [ Time Frame: After completion of therapy: every 4 wks for 3 mos, then every 6 wks for 6 mos, then every 2 mos for 12 mos, then every 3 mos for 2 yrs, then every 6 mos for 5 years ]
- To evaluate: acute and late morbidity related to treatment; local & distant recurrence, disease free & overall survival; identify factors/parameters associated with increased risk of treatment morbidity [ Time Frame: After completion of therapy: every 4 wks for 3 mos, then every 6 wks for 6 mos, then every 2 mos for 12 mos, then every 3 mos for 2 yrs, then every 6 mos for 5 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ECOG performance status of 0-2
- Good pulmonary function precluding radiation therapy (FEV>1 L or >40% predicted or DLCO >45% predicted)
- Any patient wiht a new histological diagnosis of malignancy pleural mesothelioma (MPM). Sarcomatoid or biphasic histologies can be included but will be analyzed separately due to their poor prognosis
- Stage T1-2N0M0 based on conventional investigations and tests. Selected stage T3N0M0 may be included at the discretion of the surgeon if deemed resectable.
- Suitable for combined modality therapy
- Informed consent
Exclusion Criteria:
- Distant metastatic disease
- 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 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797719
Canada, Ontario | |
University Health Network | |
Toronto, Ontario, Canada, M5G 2M9 |
Principal Investigator: | John Cho, MD | University Health Network, Toronto |
Responsible Party: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00797719 |
Other Study ID Numbers: |
UHN REB 08-0106-C |
First Posted: | November 25, 2008 Key Record Dates |
Last Update Posted: | October 7, 2022 |
Last Verified: | October 2022 |
MPM Short hemithoracic IMRT |
Mesothelioma Mesothelioma, Malignant Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Pleural Neoplasms Lung Diseases Respiratory Tract Diseases |