New treatment approach for T4 esophageal cancer
A Pilot Study to Establish Best Treatment Strategy for T4 Esophageal Cancer
PHASE1; PHASE2 · National Cheng-Kung University Hospital · NCT06531434
This study is testing a new treatment plan for people with T4 esophageal cancer to see if combining chemotherapy with radiation can help them feel better and live longer.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | National Cheng-Kung University Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tainan, Taiwan) |
| Trial ID | NCT06531434 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a novel treatment strategy for T4-stage esophageal cancer, focusing on the safety and efficacy of induction chemotherapy followed by chemoradiotherapy. Participants will receive 4 to 8 cycles of induction chemotherapy, and if their condition improves, they will proceed to concurrent chemoradiotherapy. The study aims to reduce the high rate of esophageal perforation and improve treatment response rates and overall survival. Regular clinic visits and symptom diaries will be part of the participant experience to monitor progress and side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with histologically confirmed T4-stage esophageal squamous cell carcinoma.
Not a fit: Patients with previous chemotherapy history or those with other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and reduce complications for patients with T4 esophageal cancer.
How similar studies have performed: Other studies have explored similar treatment approaches, but this specific strategy is novel and aims to address significant challenges in treating T4 esophageal cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed esophageal squamous cell carcinoma 2. Tumor or lymph nodes invade adjacent organs (T4 stage) 3. Aged between 18-70 years old 4. Patient health status score Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<2 5. 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. Exclusion Criteria: 1. Previous chemotherapy history 2. Myocardial infarction within the last three months 3. History of unstable angina, interstitial pneumonia, fibrotic lung disease, or severe emphysema 4. Has other malignancies currently 5. Uncontrolled infection 6. Pregnancy or lactation 7. Perforated esophagus at the time of diagnosis
Where this trial is running
Tainan, Taiwan
- National Cheng Kung University Hospital — Tainan, Taiwan, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Wei-Lun Chang, PhD
- Email: weilun1@mail.ncku.edu.tw
- Phone: +886-6-2353535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Esophageal Cancer TNM Staging Primary Tumor T4, T4 esophageal cancer, Induction chemotherapy