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Conventional two-dimensional radiotherapy combined with conformal radiotherapy versus whole course conformal radiotherapy for advanced esophageal cancer: A pilot Randomized Controlled Trial

Conventional two-dimensional radiotherapy combined with conformal radiotherapy versus whole course conformal radiotherapy for advanced esophageal cancer: A pilot Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17013175
Enrollment
Unknown
Registered
2017-10-31
Start date
2017-12-01
Completion date
Unknown
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer

Interventions

C+CRT:conventional two-dimensional radiotherapy combined with three-dimensional conformal radiotherapy
Group 2:WCCRT treatment

Sponsors

Clinical oncology center of the 105th Hospital of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 88 Years

Inclusion criteria

Inclusion criteria: 1. Histological or cytologic diagnosis of esophageal squamous carcinoma; 2. KPS = 70; 3. Aged 18-85 years; 4. Joined the study voluntarily and signed informed consent form; 5. Not have received any prior anticancer therapy; advanced esophageal cancer (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, AJCC 6th); 6. No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin =9 g/dL, WBC=3x10^9/L, Neutrophils (ANC )=1.5x10^9/L, platelet count =100x 10^9/L, TBIL<1.5 x ULN, ALT and AST ? 2.5 x ULN, creatinine ? 1.5 x ULN; 7. Use of an effective contraceptive for adults to prevent pregnancy; 8. Life expectancy of more than 3 months. ;Inclusion criteria: 1. Histological or cytologic diagnosis of esophageal squamous carcinoma; 2. KPS = 70; 3. Aged 18-85 years; 4. Joined the study voluntarily and signed informed consent form; 5. Not have received any prior anticancer therapy; advanced esophageal cancer (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, AJCC 6th); 6. No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin =9 g/dL, WBC=3x10^9/L, Neutrophils (ANC )=1.5x10^9/L, platelet count =100x 10^9/L, TBIL<1.5 x ULN, ALT and AST ? 2.5 x ULN, creatinine ? 1.5 x ULN; 7. Use of an effective contraceptive for adults to prevent pregnancy; 8. Life expectancy of more than 3 months. ;Inclusion criteria: 1. Histological or cytologic diagnosis of esophageal squamous carcinoma; 2. KPS = 70; 3. Aged 18-85 years; 4. Joined the study voluntarily and signed informed consent form; 5. Not have received any prior anticancer therapy; advanced esophageal cancer (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, AJCC 6th); 6. No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin =9 g/dL, WBC=3x10^9/L, Neutrophils (ANC )=1.5x10^9/L, platelet count =100x 10^9/L, TBIL<1.5 x ULN, ALT and AST ? 2.5 x ULN, creatinine ? 1.5 x ULN; 7. Use of an effective contraceptive for adults to prevent pregnancy; 8. Life expectancy of more than 3 months. ;Inclusion criteria: 1. Histological or cytologic diagnosis of esophageal squamous carcinoma; 2. KPS = 70; 3. Aged 18-85 years; 4. Joined the study voluntarily and signed informed consent form; 5. Not have received any prior anticancer therapy; advanced esophageal cancer (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, AJCC 6th); 6. No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin =9 g/dL, WBC=3x10^9/L, Neutrophils (ANC )=1.5x10^9/L, platelet count =100x 10^9/L, TBIL<1.5 x ULN, ALT and AST ? 2.5 x ULN, creatinine ? 1.5 x ULN; 7. Use of an effective contraceptive for adults to prevent pregnancy; 8. Life expectancy of more than 3 months. ;Inclusion criteria: 1. Histological or cytologic diagnosis of esophageal squamous carcinoma; 2. KPS = 70; 3. Aged 18-85 years; 4. Joined the study voluntarily and signed informed consent form; 5. Not have received any prior anticancer therapy; advanced esophageal cancer (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, AJCC 6th); 6. No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin =9 g/dL, WBC=3x10^9/L, Neutrophils (ANC )=1.5x10^9/L, platelet count =100x 10^9/L, TBIL<1.5 x ULN, ALT and AST ? 2.5 x ULN, creatinine ? 1.5 x ULN; 7. Use of an effective contraceptive for adults to prevent pregnancy; 8. Life expectancy of more than 3 months.

Exclusion criteria

Exclusion criteria: 1. Pregnancy woman; 2. Complicated with acute infections, severe acute infection, suppurative and chronic infection, or the inpatient of the wound; 3. esophageal perforation (esophageal tracheal fistula or patients who may have esophageal tracheal fistulas) with clear symptoms and multiple distant metastases; 4. Received other anti-tumor treatment before enrollment; 5. coagulant function abnormal, have bleeding tendency (such as active peptic ulcer), or disease in accepting thrombolytic or anticoagulant therapy; 6. original serious heart disease, including: congestive heart failure, high-risk sexual beyond the control of the rhythm of the heart failure, unstable angina, half a year of myocardial infarction, severe valvular heart disease, and resistant hypertension; 7. patients with uncontrollable nerve, mental illness, or mental disorders, depending on the sex, cannot cooperation and adverse response for descriptive treatment; 8. severe liver cirrhosis, severe kidney dysfunction. ;Exclusion criteria: 1. Pregnancy woman; 2. Complicated with acute infections, severe acute infection, suppurative and chronic infection, or the inpatient of the wound; 3. esophageal perforation (esophageal tracheal fistula or patients who may have esophageal tracheal fistulas) with clear symptoms and multiple distant metastases; 4. Received other anti-tumor treatment before enrollment; 5. coagulant function abnormal, have bleeding tendency (such as active peptic ulcer), or disease in accepting thrombolytic or anticoagulant therapy; 6. original serious heart disease, including: congestive heart failure, high-risk sexual beyond the control of the rhythm of the heart failure, unstable angina, half a year of myocardial infarction, severe valvular heart disease, and resistant hypertension; 7. patients with uncontrollable nerve, mental illness, or mental disorders, depending on the sex, cannot cooperation and adverse response for descriptive treatment; 8. severe liver cirrhosis, severe kidney dysfunction. ;Exclusion criteria: 1. Pregnancy woman; 2. Complicated with acute infections, severe acute infection, suppurative and chronic infection, or the inpatient of the wound; 3. esophageal perforation (esophageal tracheal fistula or patients who may have esophageal tracheal fistulas) with clear symptoms and multiple distant metastases; 4. Received other anti-tumor treatment before enrollment; 5. coagulant function abnormal, have bleeding tendency (such as active peptic ulcer), or disease in accepting thrombolytic or anticoagulant therapy; 6. original serious heart disease, including: congestive heart failure, high-risk sexual beyond the control of the rhythm of the heart failure, unstable angina, half a year of myocardial infarction, severe valvular heart disease, and resistant hypertension; 7. patients with uncontrollable nerve, mental illness, or mental disorders, depending on the sex, cannot cooperation and adverse response for descriptive treatment; 8. severe liver cirrhosis, severe kidney dysfunction. ;Exclusion criteria: 1. Pregnancy woman; 2. Complicated with acute infections, severe acute infection, suppurative and chronic infection, or the inpatient of the wound; 3. esophageal perforation (esophageal tracheal fistula or patients who may have esophageal tracheal fistulas) with clear symptoms and multiple distant metastases; 4. Received other anti-tumor treatment before enrollment; 5. coagulant function abnormal, have bleeding tendency (such as active peptic ulcer), or disease in accepting thrombolytic or anticoagulant therapy; 6. original serious heart disease, including: congestive heart failure, high-risk sexual beyond the control of the rhythm of the heart failure, unstable angina, half a year of myocardial infarction, severe valvular heart disease, and resistant hypertension; 7. patients with uncontrollable nerve, mental illness, or mental disorders, depending on the sex, cannot cooperation and adverse response for descriptive treatment; 8. severe liver cirrhosis, severe kidney dysfunction. ;Exclusion criteria: 1. Pregnancy woman; 2. Complicated with acute infections, severe acute infection, suppurative and chronic infection, or the inpatient of the wound; 3. esophageal perforation (esophageal tracheal fistula or patients who may have esophageal tracheal fistulas) with clear symptoms and multiple distant metastases; 4. Received other anti-tumor treatment before enrollment; 5. coagulant function abnormal, have bleeding tendency (such as active peptic ulcer), or disease in accepting thrombolytic or anticoagulant therapy; 6. original serious heart disease, including: congestive heart failure, high-risk sexual beyond the control of the rhythm of the heart failure, unstable angina, half a year of myocardial infarction, severe valvular heart disease, and resistant hypertension; 7. patients with uncontrollable nerve, mental illness, or mental disorders, depending on the sex, cannot cooperation and adverse response for descriptive treatment; 8. severe liver cirrhosis, severe kidney dysfunction.

Design outcomes

Primary

MeasureTime frame
PFS;

Countries

China

Contacts

Public ContactDonglai Lv;Donglai Lv;Donglai Lv;Donglai Lv;Donglai Lv ;;;;

The 105th Hospital of People Liberation Army;The 105th Hospital of People Liberation Army;The 105th Hospital of People Liberation Army;The 105th Hospital of People Liberation Army;The 105th Hospital of People Liberation Army

lvxunhuan@163.com;lvxunhuan@163.com;lvxunhuan@163.com;lvxunhuan@163.com;lvxunhuan@163.com+86 13655600090;+86 13655600090;+86 13655600090;+86 13655600090;+86 13655600090

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026