Esophageal Cancer
Conditions
Keywords
Esophageal cancer, Simultaneous modulated accelerated boost, Standard dose radiotherapy, Chemotherapy, Survival
Brief summary
This randomized phase III trial is to compare simultaneous modulated accelerated boost with standard dose radiotherapy given together with chemotherapy in treating patients with esophageal squamous cell carcinoma.
Interventions
RADIATIONRadiotherapy with simultaneous modulated accelerated boost
Radiotherapy: 66Gy/30F to the gross tumor and 50Gy/25 to subclinical diseases
RADIATIONStandard dose radiotherapy
Radiotherapy: 50Gy/25F to both gross tumor and subclinical disease
DRUGPF
Chemotherapy: Cisplatin and 5fluorouracil
Sponsors
Chuangzhen Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologic proof of primary squamous cell carcinoma of the esophagus. * Primary disease at cervical, upper or middle thoracic esophagus * T1-4, N any, M0 (except supraclavicular lymph node). * Age≥18 & ≤75. * ECOG score 0-2. * Platelets ≥ 150,000, Hgb ≥ 10 gm%, ANC ≥ 1500, serum creatinine ≤ 1.5 mg/dl. * Adequate liver function. * Patients with prior malignancy are eligible if disease-free ≥ 5 years. * No prior chest radiotherapy, systemic chemotherapy or major esophageal surgery. * Signed study-specific informed consent form prior to study entry.
Exclusion criteria
* Patients with tracheo-esophageal fistula. * Patients with invasion into mucosa of trachea or major bronchi. * Patients with uncontrolled serious medical or mental illnesses. * Prior RT that would result in overlap of planned RT fields. * Pregnancy or women of childbearing potential and men who are sexually active * Women who are breastfeeding a baby.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant metastasis-free survival | 2 years | — |
| Disease-free survival | 2 years after randomization | — |
| Acute and late toxicities using CTCAE v4.0 | 2 years | The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs. |
| Local-regional control | 2 years | — |
| Quality of life as measured with EQ-5D | 2 years | The score of EQ-5D questionnaire |
| Biomarkers | 2 years | — |
| Quality of life as assessed with FACT-E | 2 years | FACT-E score |
Countries
China
Outcome results
None listed