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A Feasibility Study Evaluating Neoadjuvant Hemithoracic Intensity Modulated Radiation Therapy for Surgically Resectable Malignant Pleural Mesothelioma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Malignant Pleural Mesothelioma

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Trial Information

A Feasibility Study Evaluating Neoadjuvant Hemithoracic Intensity Modulated Radiation Therapy for Surgically Resectable Malignant Pleural Mesothelioma

The study is a phase I/II prospective single cohort clinical feasibility study. 25 patients
with early stage resectable malignant pleural mesothelioma will be enrolled into the study.
Patients will have a baseline PET scan. Patients on the study will receive IMRT for
approximately 1 week of 5 daily treatments. 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 OR Pemetrexed and cisplatin, will be given 6-12 weeks post-surgery. Before and
during treatment, side effects will be assessed. After treatment, follow up visits will be
conducted every 1 to 2 months for the first year, and every 3 months for the second year.
At each visit, a history and physical examination will be performed and ECOG performance
status will be assessed. Routine tests will include CBC, liver profile, creatinine and
chest x-ray. CT thorax and abdomen will be done at 3, 6, 12, 18, and 24 months. Additional
test may be done at the discretion of the oncologist if the patient becomes symptomatic.
The study will evaluate the feasibility and safety of short pre-operative RT, and may help
confirm the intraoperative seeding hypothesis. Preoperative RT may also reduce the risk of
both local and distant spread and, ultimately, improve overall survival. By shortening
overall treatment time, it may also improve patient compliance and convenience. We may be
able to give chemotherapy only to patients that are at highest risk and avoid it in others.

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary outcome for the study will be the proportion of patients treated as per protocol without treatment related mortality.

Outcome 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

Safety Issue:


Principal Investigator

John Cho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Ethics Review Committee

Study ID:

UHN REB 08-0106-C



Start Date:

October 2008

Completion Date:

October 2014

Related Keywords:

  • Malignant Pleural Mesothelioma
  • MPM
  • Short hemithoracic IMRT
  • Mesothelioma