Radiotherapy With or Without Concurrent Chemotherapy for Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-03

Study Overview
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Brief Summary
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The investigators aimed to compare elective nodal irradiation versus involved field irradiation with or without concurrent chemotherapy and the addition of consolidation chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer.

Official Title
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A Randomized Phase III Study of Simultaneous Integrated Boost Intensity Modulated Radiation Therapy (SIB-IMRT) With or Without Concurrent Chemotherapy Followed by Consolidation Chemotherapy for Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P03

Conditions
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IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer

Intervention / Treatment
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* Radiation: SIB-IMRT
* Drug: Paclitaxel
* Drug: Platinum-Based Drug
* Drug: Paclitaxel
* Drug: Platinum-Based Drug
* Other: Involved Field Irradiation (IFI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age<70 Diagnosis of clinical stage T2-4N0-1M1（According to UICC 2002） A untreated squamous esophageal carcinoma Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3 Adequate organ function No known history of drug allergy Blood routine examination : WBC≥4.0 hepatic and renal function are normal Exclusion Criteria: Age≥ 70 or ≤ 16 Already received the treatment of chemotherapy or radiotherapy Pregnant or lactating females Known drug allergy Without agreement of informed consent form Insufficient hepatorenal function or Blood routine examination Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIB-IMRT combined chemotherapy with IFI<br> | Radiation: SIB-IMRT<br>* Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.<br>Drug: Paclitaxel<br>* 45-50mg/m2, once a week, concurrent with radiotherapy for 5-6weeks<br>Drug: Platinum-Based Drug<br>* Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks<br>Drug: Paclitaxel<br>* 135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy<br>Drug: Platinum-Based Drug<br>* Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy<br>Other: Involved Field Irradiation (IFI)<br>* CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin.<br>|
| Experimental: SIB-IMRT with IFI<br> | Radiation: SIB-IMRT<br>* Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.<br>Drug: Paclitaxel<br>* 135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy<br>Drug: Platinum-Based Drug<br>* Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy<br>Other: Involved Field Irradiation (IFI)<br>* CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) |  | 1 year | 
| Overall survival (OS) |  | 2 year | 
| Overall survival (OS) |  | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | 1 year | 
| Progression-free survival (PFS) |  | 2 year | 
| Progression-free survival (PFS) |  | 3 year | 
| Local recurrence-free rate（LRFS） |  | 1 year | 
| Local recurrence-free rate（LRFS） |  | 2 year | 
| Local recurrence-free rate（LRFS） |  | 3 year | 
| Completion Rate |  | up to 2 year | 
| Adverse events |  | up to 5 year |