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NCT Number: NCT02988921

MRI and CT Simulation in the Evaluation of Tumor Response and Target Volume Definition for Esophageal or Esophagogastric Cancer Patients Undergoing Chemoradiotherapy

Magnetic resonance imaging (MRI) with functional features of diffusion weighted imaging (DWI) are advancing imaging technologies that have potential to overcome limitations of conventional staging methods, radiation treatment planning and the assessment of tumor response in esophageal or esophagogastric cancer. This study aimed to explore the value of MRI for the prediction of tumor response to chemoradiotherapy and accurate target volume delineation as compared to CT simulation for patients with unresectable or potentially resectable esophageal or esophagogastric cancer undergoing chemoradiotherapy. The average CT texture features are also extracted before and during treatment to establish a model to predict the prognosis or side effects (e.g. radiation pneumonitis or esophagitis) of patients.

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Key information

Conditions

Esophagus Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophagogastric Junction Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Beijing, 100021, China

Location status: Recruiting

Location contact

Xin Wang, MD

CONTACT

[email protected]

+861013311583220

About this study

  • Both DW-MRI and CT simulation will be performed before chemoradiotherapy and after 18-22 fractions. Also MRI will be performed after treatment. The investigators will contour based on the MRI image and compare this with the standard CT plan before and during treatment.
  • The predictive potential of initial tumor ADC, and change in ADC during and after treatment for tumor response will be assessed.
  • The average CT texture features not only in the present study but also of those who treated previously in our department (since 2014) will be extracted before and during chemoradiotherapy to establish a model to predict the prognosis of patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed squamous cell carcinoma, adenocarcinoma of the esophageal or esophagogastric junction
  • Unresectable or potentially resectable tumor (cT3-4N0-1M0-M1a, according to AJCC 6th) based on standard primary staging by EUS and CT
  • Age>18 years
  • No distant metastasis other than supraclavicular lymph nodes
  • No prior history of thoracic radiation or chemotherapy
  • Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
  • Informed consent

Exclusion criteria

  • Contraindication for MRI scanning
  • Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
  • Pregnant or lactating females
  • Contraindication for radiotherapy or chemotherapy

Treatment and study plan

MRI and CT

Device

Ratiotherapy

Radiation

Paclitaxel, platinum-based drug

Drug

Primary outcomes

  1. Tumor response based on MRI and CT simulation

    Time frame: up to 8 weeks

  2. Radiotherapy target volume assessment with pre- and post-chemoradiotherapy based on MRI and CT simulation

    Time frame: up to 8 weeks

  3. Evaluation of tumor heterogeneity with IBEX software

    Time frame: up to 8 weeks

    Using the average CT images for texture extraction. Histogram, gradient, cooccurrence, gray-tone difference, and filtration-based techniques are used for texture feature extraction. Models incorporating texture features are established to compare to models incorporating clinical prognostic factors alone.

Secondary outcomes

  1. Overall survival

    Time frame: 1 year

  2. Progress free survival

    Time frame: 1 year

  3. Reduction in acute and late side effects based on modified RT treatment volumes with pre- and post-chemoradiotherapy based on MRI and CT simulation

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Wang, MD

CONTACT

[email protected]

+861013311583220

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Dec 12, 2016
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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