NCT02653521

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 28, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

December 30, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

3 years

First QC Date

December 28, 2015

Last Update Submit

October 10, 2017

Conditions

Esophageal Cancer

Keywords

Esophageal CancerAdaptive Radiation Therapy

Outcome Measures

Primary Outcomes (1)

  • 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).

    One year

Secondary Outcomes (2)

  • Progress Free Survival(PFS）

    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）

    2 years

Other Outcomes (1)

  • Dosimetric Parameters

    Six weeks

Study Arms (2)

adaptive radiation therapy (ART)

EXPERIMENTAL

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

the control group

NO INTERVENTION

40 patients treated with original plan for full treatment course.

Interventions

Dose adaptationRADIATION

Replanning the treatment to adapt the change of PTV and movement of OARs to achieve an optimal dose distribution using online CBCT images.

adaptive radiation therapy (ART)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 19775828BACKGROUND

  • 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.

    PMID: 22079402BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Deng Xiaowu, PHD.

    Sun Yat-sen University

    STUDY DIRECTOR

  • Liu Hui, PHD.

    Sun Yat-sen University

    STUDY DIRECTOR

  • Peng Yinglin, MD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Qiu Bo, PHD.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Hui, PHD.

CONTACT

+86 020-8734-3031liuhui@sysucc.org.cn

Qiu Bo, PHD.

CONTACT

+86 020-8734-3031qiubo@sysucc.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of radiotherapy department

Study Record Dates

First Submitted

December 28, 2015

First Posted

January 12, 2016

Study Start

December 30, 2015

Primary Completion

December 30, 2018

Study Completion

December 30, 2019

Last Updated

October 11, 2017

Record last verified: 2017-10

Locations

CN(1)