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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02653521
• Other study ID #: M201505
• Status: Recruiting
• Phase: N/A
• First received: December 28, 2015
• Last updated: October 10, 2017
• Start date: December 30, 2015
• Est. completion date: December 30, 2019

Study information

• Verified date: October 2017
• Source: Sun Yat-sen University
• Contact: Liu Hui, PHD.
• Phone: +86 020-8734-3031
• Email: liuhui[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dosimetric Parameters	Accumulated dose distribution of the full treatment course.	Six weeks
Primary	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	Progress Free Survival(PFS)	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.
Secondary	Overall Survival(OS)	The survival time from the start of treatment to death or the time of the last follow-up of this study.	2 years