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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • MRI and CT

    Device
  • Ratiotherapy

    Radiation
  • Paclitaxel, platinum-based drug

    Drug

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Esophageal or esophagogastric cancerExperimental treatment 3 interventions

Trial outcomes

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

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.

Time frame
up to 8 weeks

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

Other outcomes

Sponsors and contacts

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