The Clinical Physics Research of Image Guided Adaptive Radiation Therapy for Esophagus Cancer

October 10, 2017 updated by: Deng Xiaowu, Sun Yat-sen University
The purpose of this study is to evaluate the benefit of adaptive radiation therapy (adaptive radiation therapy, ART) for esophageal cancer, using dose tracking technique with online images and deformable registration.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of study is to evaluate the benefit of adaptive radiation therapy(ART) for esophageal cancer. 80 patients with locally advanced esophageal cancer will be treated with 3D-CRT(three dimensional conformal radiotherapy, 3D-CRT)/IMRT(intensity modulated radiotherapy, IMRT), dividing to experimental group and control group (40 patients each). All patients are kVCT(kilo-voltage computed tomography, kVCT) scanned weekly(the fifth fraction in a week) and CBCT (cone beam computed tomography, CBCT) scanned per fraction before treatment. Irradiated dose distribution of each patient is calculated using the CBCT images corrected with validated modelling and accumulate the volumetric dose for all PTV(planning target volume,PTV) and OARs(organs at risk, OAR) using deformable registration algorithm. For the experimental group, replan the treatment when the target volume is not covered by the prescribed dose or OARs is overdose beyond the action level to achieve an optimal dose distribution. Conversely, no action is taken in the control group and the original plan will be used for the full treatment course. Dosimetric parameters (such as the ratio of target coverage, the mean dose of OARs, etc) ,treatment toxicities (such as radiation pneumonitis and esophagitis), PFS（Progress Free Survival,PFS）and OS（Overall Survival, OS）of the two groups will be analyzed and compared in the study.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peng Yinglin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with locally advanced esophageal cancer
  • ECOG(Eastern Cooperative Oncology Group, ECOG) physical status score：0-2
  • Charlson complications index score≤4
  • First second forced expiratory volume ≥1 liter
  • Patients and their families agreed and signed the informed consent

Exclusion Criteria:

  • Previous treatment with other malignant tumor
  • Had anti-tumor treatment, including (chemotherapy, radiotherapy, surgery)
  • Any taboo disease or condition of radiotherapy and chemotherapy
  • With malignant pleural effusion and pericardial effusion
  • Participated to other clinical test within 30 days before this experiment
  • With uncontrolled seizures or loss of mental self-control
  • Drug takers, chronic alcoholism, and HIV/AIDS patients
  • Has a history of severe allergic or specific physique
  • Researchers think that is unfavorable to the test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: adaptive radiation therapy (ART)
40 patients treated with ART, using dose adaptation method to match the change of PTV and movement of OARs and achieve an optimal dose distribution using online CBCT images.
Radiation: Dose adaptation
Replanning the treatment to adapt the change of PTV and movement of OARs to achieve an optimal dose distribution using online CBCT images.
No Intervention: the control group
40 patients treated with original plan for full treatment course.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity of treatment
Time Frame: One year
Evaluating the treatment toxicity weekly during treatment course and at the time of one year after treatment according to the NCI CTCAE 4.0 (The National Cancer Institute Common Terminology Criteria for Adverse Events,NCI-CTCAE, Version 4.0).
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress Free Survival(PFS）
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
the length of time during and after the treatment of a disease
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Overall Survival（OS）
Time Frame: 2 years
The survival time from the start of treatment to death or the time of the last follow-up of this study.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosimetric Parameters
Time Frame: Six weeks
Accumulated dose distribution of the full treatment course.
Six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Director: Deng Xiaowu, PHD., Sun Yat-sen University
  • Study Director: Liu Hui, PHD., Sun Yat-sen University
  • Principal Investigator: Peng Yinglin, MD, Sun Yat-sen University
  • Principal Investigator: Qiu Bo, PHD., Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 30, 2015

Primary Completion (Anticipated)

December 30, 2018

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

December 28, 2015

First Submitted That Met QC Criteria

January 9, 2016

First Posted (Estimate)

January 12, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M201505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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