Tomotherapy Treatment for Mesothelioma

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Brief Title

Tomotherapy Treatment for Mesothelioma

Official Title

Tomotherapy Treatment for Mesothelioma

Brief Summary

      Mesothelioma is an incurable cancer involving the lining of the lung. Patients usually suffer
      progressive symptoms of shortness of breath and chest pain, until they ultimately succumb to
      the disease. While a very small number of patients qualify for aggressive treatment with
      surgery, chemotherapy and radiation, and enjoy long-term survival, the vast majority of
      patients have incurable disease. The treatment options currently available, including
      chemotherapy and radiation treatment, are only modestly effective at alleviating symptoms and
      improving life expectancy. This trial explores the use of new radiation technology
      (tomotherapy), to treat mesothelioma more aggressively than has been possible before.
      Tomotherapy's ability to treat unusual shaped tumours, particularly when they are wrapped
      around sensitive normal tissues (the lung), enable higher doses of radiation to be used and
      this may improve its effectiveness. We will treat 17 patients with tomotherapy and assess the
      breathing, symptoms, and quality of life of the patients before and after treatment
    

Detailed Description

      Background

      Malignant mesothelioma of the pleura is one of the most challenging diseases to treat in
      oncology. It is often associated with previous exposure to asbestos many years in the past
      with the mean latency period between asbestos exposure and the development of mesothelioma
      being approximately 48 years. The disease most commonly presents in the fifth to seventh
      decade of life, and the natural history is one of relentless progression and eventual death
      in nearly all patients. It can metastasize to regional nodes and/or distant sites, but most
      of the morbidity and mortality comes from local disease in the chest, causing progressive
      constriction, and death from pulmonary insufficiency or infection. Common clinical
      manifestations can include pleural effusions, superior vena cava obstruction, dysphagia, and
      laryngeal nerve palsy. Median survival rates are generally less than one year from the time
      of diagnosis, although there may be a small subset of patients with more indolent disease
      that have longer survival durations. Patients generally suffer from significant symptoms over
      the course of their illness, particularly progressive dyspnea and chest pain.

      Treatment options with mesothelioma

      The treatment of mesothelioma has been characterized by disappointment. The only form of
      "curative" treatment that has been attempted is a combination of surgery (extrapleural
      pneumonectomy), chemotherapy, and radiation treatment to the hemithorax. This was described
      by Sugerbaker, who reported 5-year survival rates of 22% of 120 patients treated.
      Unfortunately, this approach is only possible for early stage disease (clinical stage I with
      no nodal involvement) in the absence of comorbid medical illness, and the vast majority of
      patients present with disease too advanced to consider this approach.

      Role of radiotherapy in malignant mesothelioma:

      Radiation therapy has been used with both radical and palliative intent. Radical treatment
      with tumoricidal doses is difficult to achieve with conventional treatment machines due to
      the dose limitations of normal tissues. The liver, heart, stomach, and normal lung tissue is
      routinely encompassed within the planning target volumes and all of these tissues have
      tolerances below the doses necessary to control disease. Curative (adjuvant) treatment has
      also been given after extrapleural pneumonectomy, which does not have the problem of
      underlying lung to deal with, but the other nearby normal structures are still difficult to
      avoid.

      A main component of the problem in both curative and adjuvant radiotherapy is the presence of
      chest wall and diaphragm motion during radiotherapy. Breathing motion affects the chest wall
      and diaphragm primarily, two of the principal targets in mesothelioma. Maneuvers such as
      breath holding and respiratory gating, which have shown limited success in lung cancer
      radiotherapy, are more difficult in mesothelioma due to the presence of significant dyspnea
      and pain in a majority of patients. Clearly any attempt to treat the thoracic pleura with
      high-dose radiotherapy must either limit or at least account for this organ motion.

      The published results from treating mesothelioma with primary radiotherapy have been
      suboptimal. High dose treatment to the hemithorax using conventional linear accelerators has
      typically resulted in complete loss of function of the underlying lung, with no survival
      benefit over palliative radiotherapy or no treatment. However, studies have suggested that
      specific symptoms can be effectively palliated with focused radiation treatment. Gordon et al
      reviewed 29 courses of palliative radiotherapy in 19 patients, with varying
      dose/fractionation schedules. Overall 11/29 treatment courses resulted in complete,
      "substantial", or partial relief of symptoms. Furthermore, palliation of symptoms strongly
      correlated with doses over 40 Gy, suggesting a dose-response relationship. Other
      investigators have shown effective palliation with lower doses. Davis et al treated patients
      with 20-30 Gy in 4-10 fractions, with response rates of 60-68%. De Graaf-Strukowska showed
      50% pain response rates in patients treated to a mean dose of 36 Gy at a minimum of 4 Gy per
      fraction.

      These studies suggest that although radiation is an effective treatment modality against
      mesothelioma, the technical difficulties in treating the pleural space effectively limit the
      risk-benefit ratio.

      Helical tomotherapy as a technique to treat mesothelioma

      Tomotherapy is a relatively new technology which delivers intensity modulated radiation in a
      helical fashion, much like a spiral CT scan. Because treatment is given from all angles
      around a patient, the resulting dose distributions are highly conformal and effectively
      reduce nearby normal tissues. Mesothelioma was identified early in tomotherapy's development
      as an ideal site for this technology, since the target volume is extremely difficult to treat
      using conventional techniques but well suited to the tangential beams of tomotherapy. A test
      plan using tomotherapy to "treat" a sample patient resulted in excellent dose coverage of the
      pleural disease with acceptable dose delivered to the ipsilateral and contralateral lungs
      [unpublished data]. Nevertheless, these test plans were designed on static systems in the
      absence of respiratory motion, so the feasibility of treatment on breathing patients remains
      unproven. Tomotherapy is currently in routine clinical and research use in several centres
      across North America, including the Cross Cancer Institute where it was commissioned in 2003.

      Study Objectives

      Primary Endpoint

      The primary endpoint is disease-specific symptom control rate post-treatment, based on
      Palliation Index [Gordon 1982].

      Secondary Endpoints

      Overall survival Radiographic response rate at 3 months post-treatment Quality of life scores
      (QLQ-L30) at 1-, 3- and 6-months post-treatment Acute and subacute toxicity of treatment
      Feasibility of using cine-MR, using 3T-MRI, to define target volumes in mesothelioma
      Performance status at 1-, 3- and 6-months post-treatment Pulmonary function test results at
      1-, 3- and 6-months post-treatment

      Study Design

      Description of the study

      This is a single institution single-arm phase II study, assessing the efficacy of
      tomotherapy-delivered radiation in patients with symptomatic mesothelioma. Patients are
      treated with radiation alone (no concurrent chemotherapy), and assessed for symptoms and
      performance status post-therapy.

      Duration of study

      Based on our statistical analysis (see below), we will require 14 analyzable patients. With a
      potential drop-out rate of 20%, we will accrue 17 patients in total. Assuming a possible
      accrual rate of one patient every 1-2 months, it may take 24-34 months to complete the
      accrual process.

      Selection of Patients

      Eligibility Criteria

      Histologic diagnosis of pleural mesothelioma Age>18 Life expectancy > 4 months Able to
      breathe comfortably in a supine position for periods of approximately 20 minutes (with or
      without supplemental O2) Has denied treatment with pemetrexed chemotherapy, or has evidence
      of progressive or refractory disease on treatment with pemetrexed.

      Not eligible or has declined aggressive multimodality (surgical) management for early-stage
      disease Signed informed consent CT scan of chest performed within 6 weeks of study entry

      Ineligibility Criteria

      Any contraindications to thoracic radiotherapy In the judgment of the treating physician,
      inadequate pulmonary reserve to tolerate the proposed radiotherapy.

      Unable to perform shallow breathing in a manner to make tomotherapy delivery possible
      Presence of symptomatic distant metastatic disease

      Pre-treatment imaging

      Pre-simulation imaging is required as part of this study in order to quantify the extent of
      chest wall and diaphragm movement during the breathing cycle. Two approaches to this analysis
      are acceptable: MR imaging (using the 3T MRI in the CBIAR facility) or CT/fluoroscopy (using
      equipment in the radiation oncology department). The decision on which technique to use will
      depend on the status of the MRI equipment for breathing assessment at the time of patient
      accrual.

      Patient follow-up and evaluations

      Baseline 1- month 3-months 6-months History/physical a a a a PFTs a a a a PS a a a a
      Palliation index a a a a QOL a a a a CT chest a a Planning MR imaging a

      Statistical considerations

      The number of patients required is based on the estimated efficacy of the proposed treatment
      regimen and the desired level of statistical significance. The table below indicates the
      relationship between these factors and the number of patients required:

      Response rate Required "n" P-value 0.05 59 0.048 0.10 29 0.047 0.15 19 0.046 0.20 14 0.044
      0.25 11 0.042 0.30 9 0.040

      Based on the estimated response rate of the proposed treatment (ability to achieve some
      relief of symptoms), if "n" patients are treated then at least one patient will demonstrate a
      measurable response more than 95% of the time. In this study, an efficacy of 20% was chosen
      as a worst-case scenario, below which the treatment would likely not be offered for
      palliation. Therefore, 14 evaluable patients will be required to refute the null hypotheses
      of the treatment being ineffective.

      If the true efficacy rate is higher, then the likelihood of a false negative result is lower,
      and an estimate of the true response rate can be learned.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Quality of Life

Secondary Outcome

 Breathing Function

Condition

Mesothelioma

Intervention

Tomotherapy


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

18

Start Date

October 2006

Completion Date

May 2015

Primary Completion Date

May 2015

Eligibility Criteria

        Inclusion Criteria:

          -  histologic mesothelioma

          -  refused/ineligible for surgery or chemotherapy

          -  life expectancy >3 months

        Exclusion Criteria:

          -  contraindications to thoracic radiotherapy

          -  unable to lie flat for duration of radiation therapy
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Rufus Scrimger, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00469196

Organization ID

LU-11-0077 / 22933


Responsible Party

Sponsor

Study Sponsor

AHS Cancer Control Alberta


Study Sponsor

Rufus Scrimger, MD, Principal Investigator, AHS Cancer Control Alberta


Verification Date

March 2016