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

NCT ID: NCT02988921

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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1. 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.
2. The predictive potential of initial tumor ADC, and change in ADC during and after treatment for tumor response will be assessed.
3. 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.

Conditions

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Esophagus Cancer Esophagogastric Junction Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Esophageal or esophagogastric cancer

Group Type EXPERIMENTAL

MRI and CT

Intervention Type DEVICE

Ratiotherapy

Intervention Type RADIATION

Paclitaxel, platinum-based drug

Intervention Type DRUG

Interventions

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MRI and CT

Intervention Type DEVICE

Ratiotherapy

Intervention Type RADIATION

Paclitaxel, platinum-based drug

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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XIN WANG

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xin Wang, MD

Role: CONTACT

[email protected]
+861013311583220

Facility Contacts

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Xin Wang, MD

Role: primary

[email protected]
+861013311583220

Other Identifiers

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16-161/1240

Identifier Type: -

Identifier Source: org_study_id