Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
Multicenter Prospective Randomized Phase III Trial Comparing Elective to Prophylactic Regional Lymph Node Irradiation for Thoracic Esophageal Cancer
Verified date | July 2017 |
Source | The Second People's Hospital of Sichuan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study examines contrast advantages and disadvantages of elective or prophylactic nodal irradiation in the treatment of esophageal cancer with three-dimensional conformed radiotherapy.
Status | Completed |
Enrollment | 220 |
Est. completion date | July 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Age = 18 and = 80 2. ECOG performance status 0-2 3. Weight is not less than 90% of it before treatment 4. Histologically proven primary thoracic esophageal squamous cell carcinoma previously untreated stage I-III 5. Chest and abdominal contrast enhanced CT within 2 weeks prior to registration(PET/CT scan is selective) 6. WBC = 4.0X109/L ,Absolute neutrophil count (ANC) = 2.0X109/L 7. Platelets = 100X109/L 8. Hemoglobin = 90g/L(without blood transfusion) 9. AST (SGOT)/ALT (SGPT) = 2.5 x upper limit of normal, Bilirubin = 1.5 x upper limit of normal 10. Creatinine = 1.5 x upper limit of normal 11. Sign study-specific informed consent prior to study entry - Exclusion Criteria: 1. Multiple primary esophageal tumors 2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible). 3. Severe, active comorbidity, defined as follows: - Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months - Transmural myocardial infarction within the last 6 months - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration - Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. 4. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception. 5. Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy |
Country | Name | City | State |
---|---|---|---|
China | The Second People's Hospital of Sichuan | Chengdu | Sichuan |
China | GuiZhou Cancer Hospital | Guiyang | Guizhou |
China | Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University | Kunming | Yunnan |
China | Guangxi Tumor Hospital | Nanning | Guangxi |
Lead Sponsor | Collaborator |
---|---|
Chengya Chou |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | radiation pneumonitis and radiation esophagitis | radiation pneumonitis and radiation esophagitis, | Acute and late toxicities of lung and esophagus were evaluated according to RTOG criteria with CT scans every 3 months for 1 years | |
Secondary | 3-year Overall survival(OS) | 3-year Overall survival(OS) | CT scans performed every 6 months for 3 years | |
Secondary | 3-year Disease-free survival | 3-year Disease-free survival | CT scans every 6 months for 3 years | |
Secondary | Quality of life(QoL) | Quality of life(QoL) | Evaluation of quality of life every week for 3 months | |
Secondary | Local control rate/ Inside irrational field recurrence rate | Evaluation after treatment 3 months and two years in the tumor local control and key observation radiation fields inside and outside the tumor recurrence and lymph node metastatic rate. To guide the rational clinical target volume of lymph node of esophageal cancer underwnet concurrent chemoradiotherapy and to Prolong the survival time, improve the quality of life of the patients. | 2 year |
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