NCT02988921

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Oct 2016Dec 2026

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

8.3 years

First QC Date

December 5, 2016

Last Update Submit

November 21, 2023

Conditions

Esophagus CancerEsophagogastric Junction Cancer

Outcome Measures

Primary Outcomes (3)

  • 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 (3)

  • 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

    1 year

Study Arms (1)

Esophageal or esophagogastric cancer

EXPERIMENTAL
Device: MRI and CTRadiation: RatiotherapyDrug: Paclitaxel, platinum-based drug

Interventions

MRI and CTDEVICE
Esophageal or esophagogastric cancer
RatiotherapyRADIATION
Esophageal or esophagogastric cancer
Paclitaxel, platinum-based drugDRUG
Esophageal or esophagogastric cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Central Study Contacts

Xin Wang, MD

CONTACT

+861013311583220beryl_wx2000@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 5, 2016

First Posted

December 12, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations

CN(1)