Status:
UNKNOWN
Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma
Lead Sponsor:
Fudan University
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determined the best definitive radiotherapy dosage for patients with locally advanced esophageal squamous cell carcinoma.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2025
Estimated Enrollment :
646 Patients enrolled
Trial Details
Trial ID
NCT03790553
Start Date
October 15 2018
End Date
October 15 2025
Last Update
August 3 2023
Active Locations (3)
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1
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
2
Huadong Hospital
Shanghai, Shanghai Municipality, China, 200000
3
Fudan Universtiy Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032