A Pilot Study to Establish Best Treatment Strategy for T4 Esophageal Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Duration of response (DOR)
Study Overview
Brief 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
Detailed Description
The treatment of T4-stage esophageal cancer is challenging because of a high esophageal perforation rate (19%) after concurrent chemoradiotherapy. This research aims to investigate whether a novel sequential chemoradiotherapy approach can improve the treatment response rate and reduce the incidence of esophageal perforation in participants with T4-stage esophageal cancer. The proposed novel treatment strategy involves induction chemotherapy for 4 to 8 cycles. It is followed by concurrent chemoradiotherapy if down-stage had been achieved by induction chemotherapy. The study will be conducted in two phases, starting with a phase I study to determine safety, followed by a phase II study to evaluate overall efficacy. Expected outcomes include improved treatment response rates and reduced esophageal perforation rates in T4-stage esophageal cancer, offering a better treatment option for these patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Previous chemotherapy history
- •Myocardial infarction within the last three months
- •History of unstable angina, interstitial pneumonia, fibrotic lung disease, or severe emphysema
- •Has other malignancies currently
- •Uncontrolled infection
- •Pregnancy or lactation
- •Perforated esophagus at the time of diagnosis
Arms & Interventions
Induction chemotherapy followed by chemoradiotherapy
This is a single-arm study. All patients will be assigned to receive Induction chemotherapy followed by concurrent chemoradiotherapy.
Intervention: "Docetaxel", "Cisplatin", "fluorouracil", "Radiation" (Combination Product)
Outcomes
Primary Outcomes
Duration of response (DOR)
Time Frame: At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Defined as the time from CR or PR to the time of disease progression or death.
Overall response rate of the treatment
Time Frame: At week 8, week 16, and 4 weeks after completion of concurrent chemoradiotherapy (CCRT).
Overall response rate = complete response (CR) rate + partial response (PR) rate.
Secondary Outcomes
- Adverse events of treatment(During treatment (up to 24 weeks))
- Progression-free survival(At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.)
- Overall survival time(At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.)
- Esophageal perforation rate(At week 8, week 16, and 4 weeks after completion of CCRT. And at anytime when participants suffer from symptoms in suspicious of esophageal perforation, eg. chest pain, hemoptysis, and fever.)