Response Evaluation in Malignant Pleural Mesothelioma

NCT00969098 | Unknown

• 1 other identifier: ONC/OSS-02/2009
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, a few small trials have shown promising results on value of fluoro-2-deoxy-D-glucose and positron emission tomography imaging in response assessment in Malignant Pleural Mesothelioma. These studies considered different parameters in Positron Emission Tomography (PET) analysis, mainly the standardized uptake value and volume-based parameters such as total glycolytic volume.

Conditions

Malignant Pleural Mesothelioma

Keywords

Histologically proven of Malignant pleural mesothelioma;; Patients not candidate to radical surgery;; Candidate to first-line pemetrexed-based chemotherapy;

Outcome Measures

Primary Outcomes (1)

• To validate a semi-automated iterative threshold-based region growing algorithm in a previously published series of patients.

  4 months

Secondary Outcomes (2)

• To extend the analysis to another series of consecutive patients with MALIGNANT PLEURAL MESOTHELIOMA treated with first-line pemetrexed-based chemotherapy, and to perform a combined analysis of the two groups.

  4 months

• To validate the new liver-based threshold semi-automated algorithm on the GE ADW4.6 workstation with the algorithm validated in step 1 in the same subset of patients.

  4 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Histologically proven MALIGNANT PLEURAL MESOTHELIOMA and Patients not candidate to radical surgery

You may qualify if:

• Histologically proven MALIGNANT PLEURAL MESOTHELIOMA
• Patients not candidate to radical surgery
• Unidimensionally and/or bidimensionally CT-measurable disease and Candidate to first-line pemetrexed-based chemotherapy

You may not qualify if:

• Histologically not proven MALIGNANT PLEURAL MESOTHELIOMA

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Related Publications (10)

• Robinson BW, Musk AW, Lake RA. Malignant mesothelioma. Lancet. 2005 Jul 30-Aug 5;366(9483):397-408. doi: 10.1016/S0140-6736(05)67025-0.

  PMID: 16054941 BACKGROUND

• Sugarbaker DJ, Flores RM, Jaklitsch MT, Richards WG, Strauss GM, Corson JM, DeCamp MM Jr, Swanson SJ, Bueno R, Lukanich JM, Baldini EH, Mentzer SJ. Resection margins, extrapleural nodal status, and cell type determine postoperative long-term survival in trimodality therapy of malignant pleural mesothelioma: results in 183 patients. J Thorac Cardiovasc Surg. 1999 Jan;117(1):54-63; discussion 63-5. doi: 10.1016/s0022-5223(99)70469-1.

  PMID: 9869758 BACKGROUND

• Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. doi: 10.1200/JCO.2003.11.136.

  PMID: 12860938 BACKGROUND

• Ceresoli GL, Zucali PA, Favaretto AG, Grossi F, Bidoli P, Del Conte G, Ceribelli A, Bearz A, Morenghi E, Cavina R, Marangolo M, Parra HJ, Santoro A. Phase II study of pemetrexed plus carboplatin in malignant pleural mesothelioma. J Clin Oncol. 2006 Mar 20;24(9):1443-8. doi: 10.1200/JCO.2005.04.3190.

  PMID: 16549838 BACKGROUND

• Ceresoli GL, Chiti A, Zucali PA, Cappuzzo F, De Vincenzo F, Cavina R, Rodari M, Poretti D, Lutman FR, Santoro A. Assessment of tumor response in malignant pleural mesothelioma. Cancer Treat Rev. 2007 Oct;33(6):533-41. doi: 10.1016/j.ctrv.2007.07.012. Epub 2007 Aug 30.

  PMID: 17764849 BACKGROUND

• Byrne MJ, Nowak AK. Modified RECIST criteria for assessment of response in malignant pleural mesothelioma. Ann Oncol. 2004 Feb;15(2):257-60. doi: 10.1093/annonc/mdh059.

  PMID: 14760119 BACKGROUND

• Flores RM, Akhurst T, Gonen M, Zakowski M, Dycoco J, Larson SM, Rusch VW. Positron emission tomography predicts survival in malignant pleural mesothelioma. J Thorac Cardiovasc Surg. 2006 Oct;132(4):763-8. doi: 10.1016/j.jtcvs.2006.03.068.

  PMID: 17000285 BACKGROUND

• Flores RM, Akhurst T, Gonen M, Larson SM, Rusch VW. Positron emission tomography defines metastatic disease but not locoregional disease in patients with malignant pleural mesothelioma. J Thorac Cardiovasc Surg. 2003 Jul;126(1):11-6. doi: 10.1016/s0022-5223(03)00207-1.

  PMID: 12878934 BACKGROUND

• Weber WA. Use of PET for monitoring cancer therapy and for predicting outcome. J Nucl Med. 2005 Jun;46(6):983-95.

  PMID: 15937310 BACKGROUND

• Ceresoli GL, Chiti A, Zucali PA, Rodari M, Lutman RF, Salamina S, Incarbone M, Alloisio M, Santoro A. Early response evaluation in malignant pleural mesothelioma by positron emission tomography with [18F]fluorodeoxyglucose. J Clin Oncol. 2006 Oct 1;24(28):4587-93. doi: 10.1200/JCO.2006.06.8999.

  PMID: 17008700 BACKGROUND

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Mesothelioma; 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

Study Officials

• Armando Santoro, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: August 31, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 6, 2015

Record last verified: 2015-08

Locations

IT (1)