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Monitoring Efficacy of Radiotherapy in Lung Cancer and Esophageal Cancer

Monitoring Efficacy of Radiotherapy Based on Next Generation Sequencing Liquid Biopsy Technique in Lung Cancer and Esophageal Cancer: a Prospective Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04014465
Enrollment
150
Registered
2019-07-10
Start date
2019-02-01
Completion date
2022-12-01
Last updated
2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Lung Cancer

Keywords

lung cancer, esophageal cancer, radiotherapy, ctDNA

Brief summary

Lung cancer, one of the malignant tumors which poses a threat to human's health, has increased morbidity and mortality recently. Radiotherapy, as one of the common treatments, has important value in clinical application. Esophageal cancer, one of the most common digestive system cancers, has poor prognosis and high mortality. Esophageal cancer has high aggressive and many patients can't get surgical treatment because of the tumor metastasis at the time of diagnosis.Currently, chemoradiotherapy has become one of the standard treatment regimens for patients with unresectable esophageal cancer in National Comprehensive Cancer Network(NCCN). So radiotherapy is one of the most important treatments in esophageal cancer. Currently, the efficacy evaluation method of radiotherapy is by imaging examination after several courses of treatment. However, new reports suggest that circulating tumor DNA(ctDNA) has the potential to be an indicator of therapeutic effectiveness and recurrence risk.

Detailed description

Circulating free DNA (cfDNA) can be found dissolved in plasma and serum, at variable amounts. In the case of cancer patients, ctDNA is a fraction of the cfDNA derived from tumor. Currently, the ctDNA is widely used in liquid biopsy for not only does it carry the same somatic alterations as the tumor itself but also its percentage is correlated with tumor burden. This study will investigate the clinical value of efficacy evaluation and prognosis of ctDNA detecting technique in patients with radiotherapy.

Interventions

None listed

Sponsors

Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with histopathological proved lung cancer or esophageal cancer. * Candidate for radiotherapy. * No history of prior anti-tumor treatment. * Eastern Cooperative Oncology Group (ECOG) score 0,1. * Being able to receive computed tomography (CT) and magnetic resonance imaging (MRI). * Blood sample is available for dynamic monitoring. * Written informed consent provided. * Good compliance in the follow-up.

Exclusion criteria

* Had received radiotherapy, chemotherapy, biotherapy or other treatment that is related to lung cancer or esophageal cancer. * The patients have the sign of any serious or uncontrolled systematic diseases that may have significant impact on the balance between risk and benefit, such as hypertension, infection of hepatitis B, hepatitis C or human immunodeficiency virus(HIV). * With history of alcohol or drug abuse.

Design outcomes

Primary

MeasureTime frameDescription
progression free survival3 yearsthe rate of progression free survival for 3 years

Secondary

MeasureTime frameDescription
overall survival3 yearsthe rate of overall survival for 3 years
Adverse Events3 yearsNumber of Participants with Adverse Events

Countries

China

Contacts

Primary ContactNan Bi, Doctor
binan_email@163.com8613520445135
Backup ContactTao Zhang, Professor
zhangt10@126.com8618911006677

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026