Monitoring Efficacy of Radiotherapy in Lung Cancer and Esophageal Cancer

NCT04014465 | Unknown

• 1 other identifier: NCC1923
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Esophageal Cancer

Keywords

lung cancer; esophageal cancer; radiotherapy; ctDNA

Outcome Measures

Primary Outcomes (1)

• progression free survival

  the rate of progression free survival for 3 years

  3 years

Secondary Outcomes (2)

• overall survival

  3 years

• Adverse Events

  3 years

Study Arms (1)

patients with radiotherapy

The patients of lung cancer or esophagueal cancer, who received definitvie RT, should included in this Cohort.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with lung cancer or esophageal cancer intend to receive radiotherapy in Cancer hospital,Chinese academy of medical sciences.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (7)

• Chen W, Zheng R, Zhang S, Zeng H, Zuo T, Xia C, Yang Z, He J. Cancer incidence and mortality in China in 2013: an analysis based on urbanization level. Chin J Cancer Res. 2017 Feb;29(1):1-10. doi: 10.21147/j.issn.1000-9604.2017.01.01.

  PMID: 28373748 RESULT

• Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

  PMID: 25651787 RESULT

• Tepper J, Krasna MJ, Niedzwiecki D, Hollis D, Reed CE, Goldberg R, Kiel K, Willett C, Sugarbaker D, Mayer R. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781. J Clin Oncol. 2008 Mar 1;26(7):1086-92. doi: 10.1200/JCO.2007.12.9593.

  PMID: 18309943 RESULT

• Rolfo C, Castiglia M, Hong D, Alessandro R, Mertens I, Baggerman G, Zwaenepoel K, Gil-Bazo I, Passiglia F, Carreca AP, Taverna S, Vento R, Santini D, Peeters M, Russo A, Pauwels P. Liquid biopsies in lung cancer: the new ambrosia of researchers. Biochim Biophys Acta. 2014 Dec;1846(2):539-46. doi: 10.1016/j.bbcan.2014.10.001. Epub 2014 Oct 16.

  PMID: 25444714 RESULT

• Newman AM, Bratman SV, To J, Wynne JF, Eclov NC, Modlin LA, Liu CL, Neal JW, Wakelee HA, Merritt RE, Shrager JB, Loo BW Jr, Alizadeh AA, Diehn M. An ultrasensitive method for quantitating circulating tumor DNA with broad patient coverage. Nat Med. 2014 May;20(5):548-54. doi: 10.1038/nm.3519. Epub 2014 Apr 6.

  PMID: 24705333 RESULT

• Abbosh C, Birkbak NJ, Wilson GA, Jamal-Hanjani M, Constantin T, Salari R, Le Quesne J, Moore DA, Veeriah S, Rosenthal R, Marafioti T, Kirkizlar E, Watkins TBK, McGranahan N, Ward S, Martinson L, Riley J, Fraioli F, Al Bakir M, Gronroos E, Zambrana F, Endozo R, Bi WL, Fennessy FM, Sponer N, Johnson D, Laycock J, Shafi S, Czyzewska-Khan J, Rowan A, Chambers T, Matthews N, Turajlic S, Hiley C, Lee SM, Forster MD, Ahmad T, Falzon M, Borg E, Lawrence D, Hayward M, Kolvekar S, Panagiotopoulos N, Janes SM, Thakrar R, Ahmed A, Blackhall F, Summers Y, Hafez D, Naik A, Ganguly A, Kareht S, Shah R, Joseph L, Quinn AM, Crosbie PA, Naidu B, Middleton G, Langman G, Trotter S, Nicolson M, Remmen H, Kerr K, Chetty M, Gomersall L, Fennell DA, Nakas A, Rathinam S, Anand G, Khan S, Russell P, Ezhil V, Ismail B, Irvin-Sellers M, Prakash V, Lester JF, Kornaszewska M, Attanoos R, Adams H, Davies H, Oukrif D, Akarca AU, Hartley JA, Lowe HL, Lock S, Iles N, Bell H, Ngai Y, Elgar G, Szallasi Z, Schwarz RF, Herrero J, Stewart A, Quezada SA, Peggs KS, Van Loo P, Dive C, Lin CJ, Rabinowitz M, Aerts HJWL, Hackshaw A, Shaw JA, Zimmermann BG, Swanton C. Corrigendum: Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2018 Feb 8;554(7691):264. doi: 10.1038/nature25161. Epub 2017 Dec 20.

  PMID: 29258292 RESULT

• Wu Y, Li C, Yang Y, Zhang T, Wang J, Tang W, Li N, Bao H, Wang X, Bi N. Predicting Disease Progression in Inoperable Localized NSCLC Patients Using ctDNA Machine Learning Model. Cancer Med. 2024 Oct;13(20):e70316. doi: 10.1002/cam4.70316.

  PMID: 39445439 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Lung Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Nan Bi, Doctor

CONTACT

8613520445135; binan_email@163.com

Tao Zhang, Professor

CONTACT

8618911006677; zhangt10@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 10, 2019
• Study Start: February 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 1, 2022
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)