PERCIST Criteria for Response Evaluation With Solid Tumors

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.

Conditions

• Lung Neoplasms
• Breast Neoplasms
• Colonic Neoplasms
• Lymphoma

Interventions

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)

Sponsors & Collaborators

• Shengjing Hospital

  collaborator OTHER

• First Affiliated Hospital of Jinan University

  collaborator OTHER

• Harbin Medical University

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  lead OTHER

Eligibility

Min Age

30 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2018-01-31

Completion

2018-04-30

Countries

• China

Study Locations