Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma
- Conditions
- Esophageal Squamous Cell Carcinoma
- Interventions
- Radiation: Radiotherapy
- Registration Number
- NCT03790553
- Lead Sponsor
- Fudan University
- Brief Summary
The purpose of this study is to determined the best definitive radiotherapy dosage for patients with locally advanced esophageal squamous cell carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 646
- Joined the study voluntarily and signed informed consent form;
- Age 18-75 years; both genders
- Esophageal squamous cell carcinoma confirmed by pathology.
- No radiotherapy, chemotherapy or other treatments prior to enrollment
- Locally advanced esophageal squamous cell carcinoma (T1N1-3M0, T2-4NxM0, TxNxM1 (supraclavicular lymph node metastasis only) (AJCC 8th)
- Use of an effective contraceptive for adults to prevent pregnancy.
- No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function. No immunodeficiency.
- WBC ≥ 3.5*109/L, Hemoglobin ≥ 9 g/dL, Neutrophils ≥ 1·5*109/L, Platelet count ≥ 100*109/L, ALAT and ASAT < 2·5 * ULN, TBIL < 1·5 * ULN, and Creatinine < 1·5 *ULN.
- ECOG 0-2.
- Life expectancy of more than 3 months.
- Agreement of PET/CT accessment at 25-28 radiotherapy fraction.
- Total radiotherapy dose cannot reach 61.2Gy/34Fx in the condition of the nomal tissue dose complying to the standard criteria.
- Esophageal perforation, or hematemesis.
- History of radiotherapy or chemotherapy for esophageal cancer.
- History of surgery within 28 days before Day 1.
- History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years).
- Participation in other interventional clinical trials within 30 days.
- Pregnant or breast-feeding women or fertile patients who refused to use contraceptives.
- Drug addiction, alcoholism or AIDS.
- Uncontrolled seizures or psychiatric disorders.
- Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 50.4Gy Radiotherapy Total radiotherapy dose of 50.4Gy. 61.2Gy Radiotherapy Total radiotherapy dose of 61.2Gy.
- Primary Outcome Measures
Name Time Method Overall survival in PET/CT non-responders 2 years The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.
Overall survival in ITT population 2 years The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.
- Secondary Outcome Measures
Name Time Method Progression-free survival 2 years (defined as the time between Day 1 and the first event of local failure, metastatic recurrence, progression or death)
Questionnaire EORTC-QLQ-OES18 2 years A quality of life score is obtained according to the answers to the questionnaires.
Questionnaire EORTC-QLQ-C30 2 years A quality of life score is obtained according to the answers to the questionnaires.
Local control rate 2 years The time between the start of the study treatment (Day 1) and local reccurence (included the primary tumor and regional lymph node failure)
Overall survival in PET/CT responders 2 years Overall survival in patients who have SUV ≤ 4 in PET/CT analysis in 25-28 radiotherapy fractions.
Trial Locations
- Locations (3)
Huadong Hospital
🇨🇳Shanghai, Shanghai, China
Fudan Universtiy Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China