MRI and CT Simulation in the Evaluation of Tumor Response... | NCT02988921

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

NCT02988921

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Status

Recruiting

Last Update Posted

Nov 24, 2023Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Esophagus Cancer
Esophagogastric Junction Cancer

Interventions

MRI and CT
Ratiotherapy
Paclitaxel, platinum-based drug

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Jan 2025Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Dec 5, 2016

First Submission Date that Met QC Criteria

Dec 7, 2016

First Posted Date

Dec 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2023

Last Update Posted Date

Nov 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

XIN WANG, MD, Cancer Institute and Hospital, Chinese Academy of Medical SciencesPrincipal Investigator

Lead Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical SciencesOTHER

Collaborators

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Esophageal or esophagogastric cancer	Experimental		Device: MRI and CT Radiation: Ratiotherapy Drug: Paclitaxel, platinum-based drug

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI and CT	Device		Esophageal or esophagogastric cancer
Ratiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tumor response based on MRI and CT simulation		up to 8 weeks
Radiotherapy target volume assessment with pre- and post-chemoradiotherapy based on MRI and CT simulation		up to 8 weeks
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.	up to 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Overall survival		1 year
Progress free survival		1 year
Reduction in acute and late side effects based on modified RT treatment volumes with pre- and post-chemoradiotherapy based on MRI and CT simulation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xin Wang, MD	Contact	+861013311583220		beryl_wx2000@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)	Recruiting	Beijing		100021	China

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms
D004066	Digestive System Diseases
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes