Concurrent Chemoradiotherapy After Endoscopic Resection for Stage I Esophageal Carcinoma

STATUS

Recruiting
participants needed

56
sponsor

Chinese Academy of Medical Sciences

Send

Updated on 19 February 2024

See if I qualify

cancer

metastasis

squamous cell carcinoma

mucous membrane

chemoradiotherapy

bone metastases

carcinoma

esophageal carcinoma

squamous cell carcinoma of esophagus

endoscopic ultrasound

gastroscopy

bone scan

endoscopic resection

primary lesion

lymph node metastases

esophageal squamous cell carcinoma

blood pregnancy test

Summary

This is a prospective single-arm study of endoscopic resection (ER) following concurrent chemoradiotherapy for stage I esophageal squamous cell carcinoma, to find if the treatment combination is useful by assessing its safety and efficacy.

Description

The objectives are to evaluate the efficacy and safety of concurrent chemoradiotherapy after endoscopic resection in early stage esophageal squamous cell carcinoma by evaluating the effectiveness, including 3-year OS, DFS, LRFS, DMFS, LCR, DMR and QOF, and analyzing the toxicity and side effects in 3 years follow-up time.

The study preliminarily explored the recurrence patterns of solely ER for early esophageal squamous cell carcinoma with high risk factors, analyzed the rationality of target areas and dose choices in the treatment regimen of concurrent chemoradiotherapy after ER, and proposed modification schemes of the target area and dose of radiotherapy. Prospectively acquired hematological samples and tissue samples during the treatment will be tested for genetic testing, single-cell genome sequencing, transcriptome and epigenomic analysis, to screen the population with high risk of recurrence or the population who will benefit from this treatment combination.

In terms of sample size, The estimates of survival rate at 3 years for operation group is 85.1% (95% CI: 82.0%, 87.7%) based on SEER study. Assuming that the survival rate at 3 years for ER+CRT is about 90.7%. The difference between operation and ER+CRT is marginal and clinically meaningless. In our study, we will target to establish that the ER+CRT is non-inferiority to operation in term of survival rate at 3 years, and further investigate the benefit of ER+CRT in safety profile and quality of life. A non-inferiority margin 10% is applied with respect to 85.1%. A number of 50 subjects is adequate to achieve 80% statistical power under a type one error rate 0.025 one-sided. The power analysis is based on simulation, 10000 iterations are carried out, Greenwood's method is applied.

Details

Condition	Esophageal Cancer, Esophageal Cancer, Squamous cell carcinoma, Squamous cell carcinoma
Age	18years - 75years
Treatment	Chemotherapy, Intensity modulated radiotherapy (IMRT)
Clinical Study Identifier	NCT04275986
Sponsor	Chinese Academy of Medical Sciences
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Male or female patients aged 18 to 75 years (18 years and 75 years are inclusive)
	The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 to 1 point
	Weight loss (intentional or unintentional) of less than or equal to 10% of body weight in the 6 months prior to surgery
	Complete radiological staging is required before ER, including gastroscopy, endoscopic ultrasonography, chest CT, brain MRI and bone scan (if positive, bone metastasis must be confirmed by MRI or CT examination of corresponding parts, otherwise bone metastasis cannot be determined). No lymph nodes with shorter diameter >10mm in mediastinum presented by endoscopic ultrasonography or chest CT. No abdominal nor neck lymph node metastases presented by B-ultrasound
	Primary lesion located in thoracic esophagus, length 5cm. Lesion 3/4 circumferential area
	Clinical stage: cT1sm1/sm2N0M0 (The 8th edition of American Joint Committee on Cancer [AJCC]) before ER
	ER is a complete removal of tumor
	Pathologically confirmed squamous cell carcinoma
	Histologically confirmed diagnosis of T1a with LVI, T1bsm1/sm2with/without LVI, or microscopically positive vertical resection margin (R1 resection)
	Less than three endoscopically resected synchronous lesions with high risk factors (lymphovascular or mucous membrane invasion, submucous infiltration, poor differentiation or microscopically positive vertical resection margin), which can be safely encompassed in a tolerable radiation plan
	Non-pregnancy and non-pregnancy plan in the next 12 months (urine pregnancy test or blood pregnancy test is required for women of childbearing age to exclude pregnancy)
	No serious medical disease nor organ dysfunction. Adequate BM, liver, kidney and heart function
	Meet the treatment and follow-up criteria, able to receive treatment, follow-up and pathological examination. The subject has voluntarily signed the written informed consent form (ICF)
Exclusion Criteria
	Any positive N or M stage
	Macroscopic residual tumor (R2 resection)
	Lesions with poor prognistic factors (lymphovascular or mucous membrane invasion, submucous infiltration, poor differentiation or microscopically positive vertical resection margin) solely resected endoscopically more than three months before evaluation
	Patients with other malignant tumors within 5 years before enrollment
	Unavailable gastroscope due to esophageal stenosis
	Previously received electrocoagulation, other treatments (including photodynamic therapy, multipolar electrocoagulation, argon plasma coagulation, laser therapy, et al.) or radiotherapy
	Previously received any esophageal surgery, excluding fundoplication with no complications (no slippage, dysphagia, et al.)
	Uncontrolled coagulation disorders: INR >2 or PLT<75,000/L
	Patients who are taking or have taken (within 7 days before/after treatment) aspirin, clopidogrel or other non-steroidal anti-inflammatory drugs
	Patients with history of uncontrolled drug or alcohol dependence that limits the ability to understand or comply with medical orders, including inability to understand and execute ICF, post-treatment orders, or follow-up guidelines
	Patients implanted pacemakers, including AICD, nerve stimulator or cardiac pacemaker, without the permission from specialist in charge
	Patients with mental disease, serious medical disease or major organ dysfunction
	Pregnant, lactating women or women without offspring
	Patients unable to understand/express informed or consent
	Patients with known allergy to platinum compounds or paclitaxel
	Other circumstances which are considered by the investigator that the subject is unsuitable to be enrolled

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

cancer

metastasis

squamous cell carcinoma

squamous cell carcinoma of esophagus

endoscopic ultrasound

lymph node metastases

esophageal squamous cell carcinoma

blood pregnancy test

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

Concurrent Chemoradiotherapy After Endoscopic Resection for Stage I Esophageal Carcinoma