Concurrent Chemoradiotherapy After Endoscopic Resection for Stage I Esophageal Carcinoma

NCT04275986 | Unknown Phase 2

• 1 other identifier: 19/313-2097
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal Squamous Cell Carcinoma; Endoscopic resection; Concurrent chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS)

  OS was defined as the time from endoscopic resection to the last follow-up time or death due to any cause.

  3-year

• Adverse events (AE)

  An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.

  3-year

Secondary Outcomes (6)

• Disease Free Survival (DFS)

  3-year

• Local Recurrence Free Survival (LRFS)

  3-year

• Disease Metastasis Free Survival (DMFS)

  3-year

• Local Control Rate (LCR)

  3-year

• Distant Metastasis Rate (DMR)

  3-year

Study Arms (1)

Experimental arm

EXPERIMENTAL

Endoscopic resection+ concurrent chemoradiotherapy

Procedure: Intensity modulated radiotherapy (IMRT); Drug: Chemotherapy

Interventions

Intensity modulated radiotherapy (IMRT) PROCEDURE

Intensity-modulated radiation therapy (IMRT) with a total dose of 45Gy in 25 fractions

Experimental arm

Chemotherapy DRUG

Nedaplatin 25 mg/m2 and Paclitaxel liposome 45mg/m2, day 1, every week, 5 weeks

Experimental arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Clinical stage: cT1（sm1/sm2）N0M0 (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, T1b（sm1/sm2）with/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).

You may not qualify if:

• 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 six 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/μL.
• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Radiotherapy, Intensity-Modulated; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Central Study Contacts

Zhouguang Hui, M.D.

CONTACT

8610-87787230; drhuizg@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Director of VIP Department

Model Details: Enrolled Patients will receive concurrent chemoradiotherapy per protocol. The radiotherapy clinical target volume will include 2 cm above and below the tumor bed and high-risk lymph nodal area. Intensity modulated radiotherapy techniques will be used with a total dose of 45Gy in 25 fractions. Chemotherapy will be conducted weekly up to 5 weeks. The specific chemotherapy regimen are Paclitaxel Liposome 45mg/m2, d1 and Nedaplatin 25mg/m2, d1.

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: January 20, 2020
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)