Identification of Breath Biomarkers in Esophageal Cancer

Completed

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Other: Breathing test

• Registration Number: NCT05557955
• Lead Sponsor: Mian XI

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.

Study Timeline

• Study First Submitted: 2022-09-24
• Study Start: 2022-09-27
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-28
• Primary Completion: 2023-10-31
• Status Verified: 2023-11
• Study Completion: 2023-11-15
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neoadjuvant chemoradiotherapy group	Breathing test	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.
Definitive chemoradiotherapy group	Breathing test	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.

Primary Outcome Measures

Name	Time	Method
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.	A predictive model based on exhaled volatile organic compounds to predict overall survival.

Secondary Outcome Measures

Name	Time	Method
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.	A predictive model based on exhaled volatile organic compounds to predict recurrence.
clinical complete response.	3 months after the treatment (plus or minus 7 days)	A predictive model based on exhaled volatile organic compounds to predict clinical complete response. Tumor response was evaluated 3 months after the completion of treatment based on CT or PET-CT scans, endoscopy with biopsies. RECIST (Response Evaluation Criteria in Solid Tumors) criteria was used to determine the tumor response.

Trial Locations

Locations (1)

Mian Xi; 🇨🇳 Guangzhou, Guangdong, China