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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| the control group | No Intervention | 40 patients treated with original plan for full treatment course. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose adaptation | Radiation | Replanning the treatment to adapt the change of PTV and movement of OARs to achieve an optimal dose distribution using online CBCT images. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Overall Survival（OS） |
| Measure | Description | Time Frame |
|---|---|---|
| Dosimetric Parameters | Accumulated dose distribution of the full treatment course. | Six weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Hui, PHD. | Contact | +86 020-8734-3031 | liuhui@sysucc.org.cn | |
| Qiu Bo, PHD. | Contact | +86 020-8734-3031 | qiubo@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Deng Xiaowu, PHD. | Sun Yat-Sen University Cancer Center | Study Director |
| Liu Hui, PHD. | Sun Yat-Sen University Cancer Center | Study Director |
| Peng Yinglin, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19775828 | Background | 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. | |
| 22079402 | Background | 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. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The survival time from the start of treatment to death or the time of the last follow-up of this study. |
| 2 years |
| Sun Yat-Sen University Cancer Center |
| Principal Investigator |
| Qiu Bo, PHD. | Sun Yat-Sen University Cancer Center | Principal Investigator |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |