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Trial record 29 of 2062 for:    Pancreatic Cancer AND Digestive System Neoplasms

PERCIST Criteria for Response Evaluation With Solid Tumors

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ClinicalTrials.gov Identifier: NCT02765620
Recruitment Status : Unknown
Verified March 2016 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Recruiting
First Posted : May 6, 2016
Last Update Posted : May 6, 2016
Sponsor:
Collaborators:
Shengjing Hospital
First Affiliated Hospital of Jinan University
Harbin Medical University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Brief Summary:

Chemo-radiotherapy and targeted therapy are widely used as non-surgical treatments for solid tumors. Early assessment of treatment response is considered efficient and helpful to clinical management and personalized therapy.RECIST 1.1 criteria was accepted widely. Complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) are defined in the RECIST criteria. This type of classification divides intrinsically continuous data (tumor size) into 4 bins, losing statistical power for ease of nomenclature and convenience. The 18F-FDG PET exam is based on metabolic information and considered to overcome limitations of anatomic imaging and more suitable for assessment of therapeutic response.PERCIST 1.0 proposes a series of detailed and unambiguous regulations about standardization procedures to ensure the reproducibility. Complete metabolic response (CMR), partial metabolic response (PMR), stable metabolic disease (SMD), and progressive metabolic disease (PMD) are defined in the PERCIST criteria.

So far, there have several studies using metabolic-based PERCIST criteria in patients with solid tumors, including lung cancer, digestive tumor and lymphoma, etc. But all of these studies had limitations of small study sample, thus were need to be further investigated. Compared to RECIST, the advantages of PERCIST were to evaluate chemotherapy, especially targeted therapy, to distinguish PMR and SMD patients from SD group in RECIST, and to better predict the response rate. Recently, several studies applied PERCIST criteria to evaluate neoadjuvant chemotherapy in pancreatic cancer and rectal cancer, and revealed the metabolic response results were well related to pathology. All these studies conclude PERCIST criteria could help making clinical therapeutic decisions. Moreover, several studies have shown that PERCIST has advantage in predicting early response of several malignant tumors.

The aim of this multicenter study is 1) to evaluate treatment response in newly diagnosed and pre-therapeutic patients with solid tumors who are going to receive a baseline , an early follow-up (after a certain period of treatment cycle) and a final (after treatment) 18F-FDG PET/CT; 2) to compared PERCIST criteria to RECIST 1.1 criteria in prediction treatment response, especially in early stage of treatment; 3) to reveal the value of PERCIST criteria in clinical therapeutic management and tailed therapy.


Condition or disease Intervention/treatment
Lung Neoplasms Breast Neoplasms Colonic Neoplasms Lymphoma Other: drug&radiation

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PERCIST Criteria for Response Evaluation of Non-surgical Therapy in Patients With Solid Tumors:Prospective Multicenter Study
Study Start Date : April 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
drug
Early treatment response assessment: using baseline data and early follow-up data Evaluate treatment response: using baseline data, early follow-up data and final data Compare PERCIST to RECIST criteria: correlation analysis Evaluate prognostic value: using baseline data, early follow-up data, final data as well as follow up PFS and OS time (Kaplan-Meier survival plot
Other: drug&radiation
  1. Early treatment response assessment: using baseline data and early follow-up data
  2. Evaluate treatment response: using baseline data, early follow-up data and final data
  3. Compare PERCIST to RECIST criteria: correlation analysis
  4. Evaluate prognostic value: using baseline data, early follow-up data, final data as well as follow up PFS and OS time (Kaplan-Meier survival plot)

radiation
Early treatment response assessment: using baseline data and early follow-up data Evaluate treatment response: using baseline data, early follow-up data and final data Compare PERCIST to RECIST criteria: correlation analysis Evaluate prognostic value: using baseline data, early follow-up data, final data as well as follow up PFS and OS time (Kaplan-Meier survival plot
Other: drug&radiation
  1. Early treatment response assessment: using baseline data and early follow-up data
  2. Evaluate treatment response: using baseline data, early follow-up data and final data
  3. Compare PERCIST to RECIST criteria: correlation analysis
  4. Evaluate prognostic value: using baseline data, early follow-up data, final data as well as follow up PFS and OS time (Kaplan-Meier survival plot)




Primary Outcome Measures :
  1. Evaluate treatment response by PERCIST to RECIST 1.1 criteria in early stage of treatment [ Time Frame: about 4 weeks ]
    Cycle 2 (each cycle is 10 days)

  2. Evaluate treatment response by PERCIST to RECIST 1.1 criteria after the whole treatment process [ Time Frame: about 6 months ]

Secondary Outcome Measures :
  1. PFS [ Time Frame: up to 3 years ]


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newly diagnosed and pre-therapeutic patients with solid tumors, including but not limited to: lung cancer, lymphoma, gastric cancer, breast cancer, colorectal cancer, ovarian cancer, cervical cancer etc.
Criteria

Inclusion Criteria:

  • Age 30-80 years old ( might differ based on certain cancer type)
  • Newly diagnosis of solid tumor proved by imaging
  • Pathology proved to be primary solid tumor
  • First PET/CT scan was performed before any kinds of anti-tumor treatment including surgery
  • No other anti-tumor treatments except for that required during the trial
  • Written and informed consent with signature before the study
  • Complete medical history and clinical record (including physical examination, electrocardiogram, hematology, biochemistry, tumor pathology etc)
  • Follow-up of PSF and OS over a year

Exclusion Criteria:

  • Pregnancy, lactation, and impaired renal or liver function
  • Receive additional anti-tumor treatments (including surgery) other than that required during the trial
  • Poorly controlled diabetes
  • Poor compliance
  • Failed to perform scans
  • Contrary to the standard operating procedures
  • Without a definite pathologic diagnosis or follow-up results
  • Not suitable for clinical trials (for example with mental illness)

Information from the National Library of Medicine

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): NCT02765620


Locations
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China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Yan Zhao, Doctor    022-23340123 ext 6012    yanzhaotj@126.com   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Shengjing Hospital
First Affiliated Hospital of Jinan University
Harbin Medical University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT02765620     History of Changes
Other Study ID Numbers: ED12345
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: May 6, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Positron-Emission Tomography
Response Criteria
solid tumor
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Colonic Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Neoplasms
Thoracic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Breast Diseases
Skin Diseases
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases