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NCT00859495 · REGISTRY CONDITION SEARCH

Trimodal Lung-Sparing Treatment of Pleural Mesothelioma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2020-08-25

The primary objective of the study is to determine the feasibility (as determined by lack of serious adverse events) and tolerability (as determined by patient's ability to complete the study) of a multimodal lung sparing regimen of surgery, interpleural and intravenous chemotherapy, and local P-32 irradiation for malignant pleural mesothelioma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Subjects Who Were Able to Complete Trimodal Therapy (Combination of Surgery, Intrapleural and Systemic Chemotherapy and P-32 Radiotherapy).

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically confirmed malignant mesothelioma, \< 20% sarcomatoid type * No radiographic or other imaging evidence of Stage IV (cardiac, mediastinal, peritoneal, other distant) disease. * Ineligible for other high priority national or institutional study. * Age \>18 years \[to physiologic 75 years\]. * Life expectancy \> 3 months. * Performance status, PS 0-2 \[Karnofsky Performance Status, KPS=70-100 %\]. * Prior therapy allowed (one prior systemic regimen) meeting the following parameters. * No prior chest radiation therapy within 6 weeks of treatment * No prior chemotherapy regimens within four weeks of treatment * Non pregnant, non-lactating. (serum HCG test will be performed in patients in whom there is a possibility of pregnancy.) * Required initial laboratory data/clinical parameters (see also Sec. 8.0) White cell count: \>3000/ul. Platelet count: \>100,000/ul. Creatinine clearance: ≥ 45 ml/min Bilirubin: \< 2 x ULN SGOT or SGPT: \< 2 x ULN * Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts. * No other coexistent malignancy. However, curatively treated or fully controlled solid tumors (other than mesothelioma) may be eligible if in the judgement of the PI, the benefit of treatment outweighs the risk. * No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection, congestive heart failure, angina pectoris, cardiac arrhythmia(s), or uncontrolled hypertension). HIV status or other severe illnesses will be assessed using medical records. Exclusion Criteria: * If any of the inclusion criteria was not met.
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Intrapleural chemotherapy plus systemic chemotherapy: Thoracoscopy to implant two intrapleural catheters followed by intrapleural chemotherapy with doxorubicin and cisplatin (weeks 1, 2, 4, 5, 7, and 8). Systemic chemotherapy treatments with cisplatin and pemetrexed during weeks 3, 6, and 9. Intrapleural radiotherapy with P-32 will be given 3 weeks after last dose of chemotherapy and 11 to 12 weeks after initial thoracoscopy.
    intervention Names
    1. Drug: Doxorubicin
    2. Drug: Cisplatin
    3. Drug: Pemetrexed
    4. Radiation: Radiotherapy
    label
    Multimodal lung sparing regimen
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Multimodal lung sparing regimen
    description
    A medication used in cancer chemotherapy, derived by chemical semisynthesis from a bacterial species.
    name
    Doxorubicin
    other Names
    1. Doxil
    type
    DRUG
  2. arm Group Labels
    1. Multimodal lung sparing regimen
    description
    Platinum-based antineoplastic
    name
    Cisplatin
    other Names
    1. Cisplatinum
    2. Platinol
    type
    DRUG
  3. arm Group Labels
    1. Multimodal lung sparing regimen
    description
    Folate Analog Metabolic Inhibitor
    name
    Pemetrexed
    other Names
    1. Alimta
    type
    DRUG
  4. arm Group Labels
    1. Multimodal lung sparing regimen
    description
    Standard procedure given 3 weeks after last dose of chemotherapy
    name
    Radiotherapy
    other Names
    1. Intrapleural radiotherapy with P-32
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
9
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    To determine the feasibility of multimodal lung sparing regimen. Intrapleural chemotherapy (12 weeks) will be administered within two weeks after surgery. Approximately 30 days post last dose of chemotherapy (+/- 14 days), the patient should be reassessed for resolution of any treatment-related toxicity which may have occurred during the course of study participation.
    measure
    Number of Subjects Who Were Able to Complete Trimodal Therapy (Combination of Surgery, Intrapleural and Systemic Chemotherapy and P-32 Radiotherapy).
    time Frame
    20 weeks
Full study description
brief Summary
The primary objective of the study is to determine the feasibility (as determined by lack of serious adverse events) and tolerability (as determined by patient's ability to complete the study) of a multimodal lung sparing regimen of surgery, interpleural and intravenous chemotherapy, and local P-32 irradiation for malignant pleural mesothelioma.
detailed Description
Current surgical and/or chemotherapeutic approaches for malignant pleural mesothelioma are unsatisfactory and have not been shown to significantly prolong survival, and often lead to worsened pulmonary function and quality of life. We will investigate whether a prospective trial of trimodal (surgery, pleural chemotherapy, and pleural radiation) therapy can improve the overall 1 year survival in patients with malignant pleural mesothelioma. The proposed treatment will include exploratory thoracoscopy, placement of Mediport catheters into the pleural space, intraoperative chemotherapy, repeated intraperitoneal chemotherapy, and intrapleural instillation of radioactive P32 to radiate the pleural surfaces. In addition, because this study is randomized, half the patients will receive an additional three intravenous systemic chemotherapy treatments of cisplatin and pemetrexed (Alimta) in tandem with their intrapleural chemotherapy (weeks 3, 6, and 9 only). The potential significance of this research is that such treatment may render it less necessary to surgically remove the affected lungs in whole or in part, in order to achieve significant disease cytoreduction. We hope to alter the currently accepted paradigm that major lung surgery is an inescapable component of such treatment, and advance the concept that a combination of judicious preparative surgery, systemic chemotherapy, and locoregional drug treatment of the pleural surfaces may offer the best hope for prolongation of survival with intact lung function.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
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      requested nct id
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      primary nct id
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      source kind
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      source record id
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      payload sha256
      33f36d26c0785980769912698a2e63d7d335fbe7847f79415c92f6aeafa573de
      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-5362bdbf0d5e99c1c250
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
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      occurrences
      1. context exact
        NCT00859495
        end
        11
        exact text
        NCT00859495
        start
        0
      offset unit
      unicode_code_points
      query cond
      Malignant Mesothelioma
      query disease state id
      ds-malignant-mesothelioma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-malignant-mesothelioma-000.json
      source file sha256
      0a018dbf1aa46f57978b6d16aa19b94d76d6d65cf1e297e889c8e599fef1fab1
      source json pointer
      /studies/34/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      b28053df5c713f243edff16bdccc4737e0e87601f6b60cdddcbe2655028ee19a

    Preserved source evidence · Not medical advice