A Pilot Study to Establish Best Treatment Strategy for T4 Esophageal Cancer

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The goal of this clinical trial is to investigate the safety and efficacy of a new treatment approach for T4-stage esophageal cancer, which involves chemoradiotherapy after induction chemotherapy. The main questions it aims to answer are: * Does the new induction chemotherapy followed by chemoradiation reduce esophageal perforation rate? * Does the new induction chemotherapy followed by chemoradiation increase treatment response rate and patient survival? Researchers will analyze the above data to see if the new treatment approach works to treat T4 esophageal cancer. Participants will: * Receive induction chemotherapy for 4 to 8 cycles, followed by chemoradiation therapy if downstage to T3 * Visit the clinic once every week for checkups and tests * Keep a diary of their symptoms

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Histologically confirmed esophageal squamous cell carcinoma

• Tumor or lymph nodes invade adjacent organs (T4 stage)

• Aged between 18-70 years old

• Patient health status score Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<2

• Hemoglobin ≥ 10 g/L, absolute neutrophil count ≥ 2×10\^3/L, platelet count ≥ 100×10\^9/L, total bilirubin ≤ 1.5 mg/L, serum transaminases ≤ 105 U/L, creatinine clearance ≥ 40 mL/min.

Locations
Other Locations
Taiwan
National Cheng Kung University Hospital
RECRUITING
Tainan City
Contact Information
Primary
Wei-Lun Chang, PhD
weilun1@mail.ncku.edu.tw
+886-6-2353535
Backup
Ching-Lin Wu, Master
n027174@mail.hosp.ncku.edu.tw
+886-6-2353535
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 22
Treatments
Experimental: Induction chemotherapy followed by chemoradiotherapy
This is a single-arm study. All patients will be assigned to receive Induction chemotherapy followed by concurrent chemoradiotherapy.
Sponsors
Leads: National Cheng-Kung University Hospital

This content was sourced from clinicaltrials.gov