Radiotherapy With or Without Concurrent Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-02

Study Overview
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Brief Summary
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This phase III trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for esophageal carcinoma with limited lymph node metastasis.

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 Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P02

Conditions
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Esophageal Neoplasms

Intervention / Treatment
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* Radiation: SIB-IMRT
* Drug: Paclitaxel
* Drug: Platinum-Based Drug
* Drug: Paclitaxel
* Drug: Platinum-Based Drug


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 < 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SIB-IMRT combined chemotherapy followed by chemotherapy<br>SIB-IMRT: 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. Concurrent chemotherapy: Paclitaxel and platinum based drug are administered once a week for at least 5 weeks during radiotherapy treatment days. | Radiation: SIB-IMRT<br>* PTV:50.4Gy/28f, PGTV:59.92Gy/28f<br>Drug: Paclitaxel<br>* 45-50 mg/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>* 150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months after completion of radiotherapy<br>Drug: Platinum-Based Drug<br>* Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy<br>|
| Placebo Comparator: SIB-IMRT Alone followed by chemotherapy<br>SIB-IMRT: 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. | Radiation: SIB-IMRT<br>* PTV:50.4Gy/28f, PGTV:59.92Gy/28f<br>Drug: Paclitaxel<br>* 150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months after completion of radiotherapy<br>Drug: Platinum-Based Drug<br>* Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy<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 |
| --- | --- | --- |
| Progress free survival（PFS） |  | 1 year | 
| Progress free survival（PFS） |  | 2 year | 
| Progress 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 | the completion rate of each arm | up to 2 year | 
| Adverse events |  | up to 5 year |