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

NCT ID: NCT02653521

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-30

Study Completion Date

2019-12-30

Brief Summary

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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

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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.

Conditions

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Esophageal Cancer

Keywords

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Esophageal Cancer Adaptive Radiation Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dose adaptation

Intervention Type RADIATION

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

the control group

40 patients treated with original plan for full treatment course.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Deng Xiaowu

Director of radiotherapy department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deng Xiaowu, PHD.

Role: STUDY_DIRECTOR

Sun Yat-sen University

Liu Hui, PHD.

Role: STUDY_DIRECTOR

Sun Yat-sen University

Peng Yinglin, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Qiu Bo, PHD.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liu Hui, PHD.

Role: CONTACT

Phone: +86 020-8734-3031

Email: [email protected]

Qiu Bo, PHD.

Role: CONTACT

Phone: +86 020-8734-3031

Email: [email protected]

Facility Contacts

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Deng Xiaowu, PHD

Role: primary

Liu Hui, PHD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 19775828 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22079402 (View on PubMed)

Other Identifiers

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M201505

Identifier Type: -

Identifier Source: org_study_id