EC-CRT-005
Predicting Clinical Outcomes Based on Dynamic Breathomics Testing in Esophageal Squamous Cell Carcinoma Receiving Chemoradiotherapy: A Prospective Observational Study (EC-CRT-005)
Sponsor study identifier
observational
210
1 country
1
Study Start
September 27, 2022
Actual (reported)Primary Completion
October 31, 2023
Actual (reported)Study Completion
November 15, 2023
Actual (reported)Neoadjuvant chemoradiotherapy (CRT) followed by surgery or definitive CRT is the standard treatment for locally advanced esophageal squamous cell carcinoma (ESCC), but the clinical outcomes are not satisfactory. Breathomics testing is a promising, non-invasive, simple method for detection and screening for ESCC. This observational study aimed to role of exhaled volatile organic compounds (VOCs) in predicting the efficacy and risk of recurrence in patients with locally advanced ESCC who received CRT.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 15, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 24, 2022
Actual (reported)September 27, 2022
Actual (reported)September 28, 2022
Actual (reported)October 31, 2023
Actual (reported)November 15, 2023
Actual (reported)overall survival.
A predictive model based on exhaled volatile organic compounds to predict overall survival.
From date of randomization until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 24 months.
clinical complete response.
3 months after the treatment (plus or minus 7 days)
recurrence.
From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
All patients will receive standard fractionation radiation therapy (RT) scheme: 40-50.4 Gy in 20-28 fractions over 4-6 weeks using intensity-modulated radiotherapy, concurrently with platinum- or taxane-based chemotherapy, with or without PD-1 inhibitors. All patients will undergo esophagectomy 6-8 weeks after the completion of neoadjuvant CRT. Dynamic breathing testing was performed before, during, and after radiotherapy.
All patients will receive standard fractionation radiation therapy (RT) scheme: 50-50.4 Gy in 25-28 fractions over 5-6 weeks using intensity-modulated radiotherapy, concurrently with platinum- or taxane-based chemotherapy, with or without PD-1 inhibitors. Dynamic breathing testing was performed before, during, and after radiotherapy.
Dynamic breathing testing will be performed before, during, and after radiotherapy. Volatile organic compounds (VOCs) will be collected.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
A total of 230 patients with ESCC who undergo neoadjuvant chemoradiotherapy or definitive radiotherapy will be included.
Mian Xi
Guangzhou, Guangdong, 510060, China
Wang P, Huang Q, Meng S, Mu T, Liu Z, He M, Li Q, Zhao S, Wang S, Qiu M. Identification of lung cancer breath biomarkers based on perioperative breathomics testing: A prospective observational study. EClinicalMedicine. 2022 Apr 16;47:101384. doi: 10.1016/j.eclinm.2022.101384. eCollection 2022 May.
Meng S, Li Q, Zhou Z, Li H, Liu X, Pan S, Li M, Wang L, Guo Y, Qiu M, Wang J. Assessment of an Exhaled Breath Test Using High-Pressure Photon Ionization Time-of-Flight Mass Spectrometry to Detect Lung Cancer. JAMA Netw Open. 2021 Mar 1;4(3):e213486. doi: 10.1001/jamanetworkopen.2021.3486.
Ruihua Xu, MD
Sun Yat-sen University
210 participants (actual enrollment reported by the registry).
First Submitted
September 24, 2022
First Posted
September 28, 2022
Study Start
September 27, 2022
Actual (reported)Contact the study team to confirm eligibility.
Markar SR, Wiggins T, Antonowicz S, Chin ST, Romano A, Nikolic K, Evans B, Cunningham D, Mughal M, Lagergren J, Hanna GB. Assessment of a Noninvasive Exhaled Breath Test for the Diagnosis of Oesophagogastric Cancer. JAMA Oncol. 2018 Jul 1;4(7):970-976. doi: 10.1001/jamaoncol.2018.0991.
Primary Completion
October 31, 2023
Actual (reported)Study Completion
November 15, 2023
Actual (reported)Last Updated
November 18, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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