EC-CRT-005: Identification of Breath Biomarkers in Esophageal Cancer

Sponsor

Mian XI (Other)

Overall Status

Recruiting

CT.gov ID

NCT05557955

Collaborator

(none)

230

Enrollment

Location

51.1

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma	Other: Breathing test

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 Design

Study Type:

Observational

Anticipated Enrollment :

230 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Predicting Clinical Outcomes Based on Dynamic Breathomics Testing in Esophageal Squamous Cell Carcinoma Receiving Chemoradiotherapy: A Prospective Observational Study (EC-CRT-005)

Actual Study Start Date :

Sep 27, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Neoadjuvant chemoradiotherapy group 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.	Other: Breathing test Dynamic breathing testing will be performed before, during, and after radiotherapy. Volatile organic compounds (VOCs) will be collected.
Definitive chemoradiotherapy group 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.	Other: Breathing test Dynamic breathing testing will be performed before, during, and after radiotherapy. Volatile organic compounds (VOCs) will be collected.

Arm

Intervention/Treatment

Neoadjuvant chemoradiotherapy group

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.

Other: Breathing test

Dynamic breathing testing will be performed before, during, and after radiotherapy. Volatile organic compounds (VOCs) will be collected.

Definitive chemoradiotherapy group

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.

Other: Breathing test

Dynamic breathing testing will be performed before, during, and after radiotherapy. Volatile organic compounds (VOCs) will be collected.

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed squamous cell carcinoma of the esophagus;
Absence of hematogenous metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan (according to UICC TNM version 8);
Age at diagnosis >18 years;
No prior cancer therapy;
Estimated life expectancy >6 months;
Eastern Cooperative Oncology Group performance status ≤ 2
No history of concomitant or previous malignancy;
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;
Ability to understand the study and sign informed consent.

Exclusion Criteria:

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