Clinical trial NCT05557955: Identification of Breath Biomarkers in Esophageal Cancer
Official title: Predicting Clinical Outcomes Based on Dynamic Breathomics Testing in Esophageal Squamous Cell Carcinoma Receiving Chemoradiotherapy: A Prospective Observational Study (EC-CRT-005)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Esophageal Squamous Cell Carcinoma
Chemoradiotherapy
Dynamic breathomics testing
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 230 patients with ESCC who undergo neoadjuvant chemoradiotherapy or definitive radiotherapy will be included.

Brief summary: 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.

Detailed description: 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma of the esophagus;
2. Absence of hematogenous metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan (according to UICC TNM version 8);
3. Age at diagnosis \>18 years;
4. No prior cancer therapy;
5. Estimated life expectancy \>6 months;
6. Eastern Cooperative Oncology Group performance status ≤ 2
7. No history of concomitant or previous malignancy;
8. The function of important organs meets the following requirements: a. white blood cell count (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b. platelets ≥ 100×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinine clearance rate \>60 mL/min;
9. Ability to understand the study and sign informed consent.

Exclusion Criteria:

1. Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
2. Patients with hematogenous metastasis disease at diagnosis;
3. Female patients who are pregnant or lactating;
4. Inability to provide informed consent due to psychological, familial, social and other factors;
5. Patients who cannot tolerate chemoradiotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia.
6. The physical condition is not enough to provide 0.5L exhalation at one time.

Primary outcomes:
measure: overall survival.
timeFrame: 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.
Secondary outcomes:
measure: clinical complete response.
timeFrame: 3 months after the treatment (plus or minus 7 days)
measure: recurrence.
timeFrame: 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.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Mian Xi
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ruihua Xu, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.