Clinical trial NCT02653521: The Clinical Physics Research of Image Guided Adaptive Radiation Therapy for Esophagus Cancer
Official title: The Clinical Physics Research of Image Guided Adaptive Radiation Therapy for Esophagus Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Keywords: Esophageal Cancer
Adaptive Radiation Therapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Toxicity of treatment
timeFrame: One year
Secondary outcomes:
measure: Progress Free Survival(PFS）
timeFrame: 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.
measure: Overall Survival（OS）
timeFrame: 2 years
Other outcomes:
measure: Dosimetric Parameters
timeFrame: Six weeks
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Deng Xiaowu, PHD.
role: STUDY_DIRECTOR
affiliation: Sun Yat-sen University
name: Liu Hui, PHD.
role: STUDY_DIRECTOR
affiliation: Sun Yat-sen University
name: Peng Yinglin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-sen University
name: Qiu Bo, PHD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.