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

Primary Purpose

Esophageal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dose adaptation
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Cancer, Adaptive Radiation Therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-Sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

adaptive radiation therapy (ART)

the control group

Arm Description

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.

40 patients treated with original plan for full treatment course.

Outcomes

Primary Outcome Measures

Toxicity of treatment
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).

Secondary Outcome Measures

Progress Free Survival(PFS)
the length of time during and after the treatment of a disease
Overall Survival(OS)
The survival time from the start of treatment to death or the time of the last follow-up of this study.

Full Information

First Posted
December 28, 2015
Last Updated
October 10, 2017
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02653521
Brief Title
The Clinical Physics Research of Image Guided Adaptive Radiation Therapy for Esophagus Cancer
Official Title
The Clinical Physics Research of Image Guided Adaptive Radiation Therapy for Esophagus Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 30, 2015 (undefined)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophageal Cancer, Adaptive Radiation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
adaptive radiation therapy (ART)
Arm Type
Experimental
Arm Description
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.
Arm Title
the control group
Arm Type
No Intervention
Arm Description
40 patients treated with original plan for full treatment course.
Intervention Type
Radiation
Intervention Name(s)
Dose adaptation
Intervention Description
Replanning the treatment to adapt the change of PTV and movement of OARs to achieve an optimal dose distribution using online CBCT images.
Primary Outcome Measure Information:
Title
Toxicity of treatment
Description
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).
Time Frame
One year
Secondary Outcome Measure Information:
Title
Progress Free Survival(PFS)
Description
the length of time during and after the treatment of a disease
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.
Title
Overall Survival(OS)
Description
The survival time from the start of treatment to death or the time of the last follow-up of this study.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Dosimetric Parameters
Description
Accumulated dose distribution of the full treatment course.
Time Frame
Six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Hui, PHD.
Phone
+86 020-8734-3031
Email
liuhui@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Qiu Bo, PHD.
Phone
+86 020-8734-3031
Email
qiubo@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deng Xiaowu, PHD.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Liu Hui, PHD.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peng Yinglin, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qiu Bo, PHD.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deng Xiaowu, PHD
Phone
+86 020-8734-3036
Email
dengxw@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Liu Hui, PHD
Phone
+86 020-8734-3031
Email
luihui@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Peng Yinglin, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19775828
Citation
Hawkins MA, Brooks C, Hansen VN, Aitken A, Tait DM. Cone beam computed tomography-derived adaptive radiotherapy for radical treatment of esophageal cancer. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):378-83. doi: 10.1016/j.ijrobp.2009.05.045. Epub 2009 Sep 21.
Results Reference
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PubMed Identifier
22079402
Citation
Sriram P, Syamkumar SA, Kumar JS, Prabakar S, Dhanabalan R, Vivekanandan N. Adaptive volumetric modulated arc treatment planning for esophageal cancers using cone beam computed tomography. Phys Med. 2012 Oct;28(4):327-32. doi: 10.1016/j.ejmp.2011.10.006. Epub 2011 Nov 10.
Results Reference
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The Clinical Physics Research of Image Guided Adaptive Radiation Therapy for Esophagus Cancer

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