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Esophageal CancerNCT02653521

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

A study testing Dose adaptation in people with Esophageal Cancer, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Esophageal Cancer
What is being tested?
Dose adaptation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
30 Dec 2015to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Liu Hui, PHD. contact

+86 020-8734-3031

liuhui@sysucc.org.cn

Qiu Bo, PHD. contact

+86 020-8734-3031

qiubo@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Deng Xiaowu, PHD, +86 020-8734-3036, dengxw@sysucc.org.cn

    Liu Hui, PHD, +86 020-8734-3031, luihui@sysucc.org.cn

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Being tested
Dose adaptation
Keywords
Esophageal Cancer, Adaptive Radiation Therapy
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02653521
Study groupRoleWhat they receive
adaptive radiation therapy (ART)Experimental40 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.
Receives: Radiation: Dose adaptation
the control groupNo intervention40 patients treated with original plan for full treatment course.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: One year

Secondary outcomes (2)

  1. Progress Free Survival(PFS）

    the length of time during and after the treatment of a disease

    Measured: 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.

  2. Overall Survival（OS）

    The survival time from the start of treatment to death or the time of the last follow-up of this study.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2016 (estimated)
  2. Study start30 Dec 2015
  3. Primary completion30 Dec 2018 (estimated)
  4. Study completion30 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02653521
Sponsor's protocol ID
M201505
Status last verified
Oct 2017
First submitted
28 Dec 2015
Last updated
11 Oct 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19775828

  • 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.

    PubMed 22079402

Questions about this trial

What is this clinical trial studying?

A study testing Dose adaptation in people with Esophageal Cancer, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Liu Hui, PHD. (+86 020-8734-3031, liuhui@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity of treatment (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02653521, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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