Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)

Study Overview
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Brief Summary
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So far, there is no specific clinical guideline for elderly patients (>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.

Detailed Description
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Up to now, definitive radiotherapy was major treatment plan for elderly ESCC patients. However, whether elective elderly patients can obtain survival benefits through chemoradiotherapy is not clear. Thus we design the clinical trail to answer the question. Three hundred and twenty elderly patients with ESCC would be recruited. There are two stratification factors including 80 years old and lymph node metastasis. The patients in the chemoradiotherapy group were treated with paclitaxel (45mg/m2) and carboplatin (AUC=2) one cycle per week for five cycles.The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival. The life quality questionnaire included QlQ-C30 and OES-18.

Official Title
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Phase III Study of Concurrent Radiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma (ESO-Shanghai 15)

Conditions
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Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Survival

Intervention / Treatment
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* Drug: Paclitaxel plus carboplatin
* Radiation: radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indicates no limit on eligibility based on the sex of participants The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study. Esophageal squamous cell carcinoma confirmed by pathology No radiotherapy, chemotherapy or other treatments prior to enrollment Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th) Use of an effective contraceptive for adults to prevent pregnancy No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function No immunodeficiency ECOG 0-1. Life expectancy of more than 3 months. Exclusion Criteria: Total radiotherapy dose cannot reach 61.2Gy/34Fx 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 Drug addiction, alcoholism or AIDS Uncontrolled seizures or psychiatric disorders

Ages Eligible for Study
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Minimum Age: 76 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 |
| --- | --- |
| Experimental: chemoradiotherapy<br>50.4Gy/28Fx; Paclitaxel plus carboplatin | Drug: Paclitaxel plus carboplatin<br>* Paclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw<br>Radiation: radiotherapy<br>* Different radiotherapy dose in different groups.<br>|
| Active Comparator: radiotherapy<br>61.2Gy/34Fx | Radiation: radiotherapy<br>* Different radiotherapy dose in different groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival difference of definitive radiotherapy and chemoradiotherapy groups | The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study. | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference of quality of life between different groups | Assess the quality of life through life quality questionnaire. | the period of treatment within 7 weeks and follow up time with an average of 3months | 
| radiation side effects | Record the radiation side effects including acute and late side effects. | acute side effects within 3 months, late side effects for 3 months later | 
| cancer specific survival | The time between the start of the study treatment (Day 1) and death from tumor or last follow-up for patients alive at the end of the study. | 3-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemoradiotherapy, esophageal squamous cell carcinoma, elderly patients, definitive radiotherapy, survival