Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus

Phase 2

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Other: Paclitaxel plus Cisplatin with radiotherapy; Other: S1 plus Cisplatin with radiotherapy

• Registration Number: NCT02586753
• Lead Sponsor: Mianyang Central Hospital

Brief Summary

The purpose of this study is to determine which regimen is better for esophageal squamous carcinoma in concurrent chemoradiation(CCRT),paclitaxel or S1 plus cisplatin.

Detailed Description

Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.

Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PT regimen (cisplatin of 20 mg/m2/d, d1-3; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles or PS regimen (cisplatin of 20 mg/m2/d, d1-3; S1(Tegafur Gimeracil Oteracil Potassium Capsule)of 50mg/m2/d, d1-14) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.

Study Timeline

• Status Verified: 2015-10
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-23
• Last Update Submitted: 2015-10-23
• Study First Posted: 2015-10-26
• Last Update Posted: 2015-10-26
• Study Start: 2015-12
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1. Pathologically proven squamous cell carcinoma of esophagus .
2. Locally advanced esophageal cancer , with no operation indication
3. M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer
4. Subjects haven't been given neither radiotherapy nor chemotherapy before
5. Age of 18-70
6. PS ≦2
7. Hemogram : WBC≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl
8. With no difficulty in eating
9. Expected lifetime ≧3 months

Exclusion Criteria

1. Invasion to surrounding organ ( T4 disease ) .

2. Distant metastasis , except M1a disease .

3. Complete obstruction of the esophagus, or patients who have the potential to develop perforation

4. Women in status of pregnancy

5. Patients who have complications exist as following:

   • Uncontrolled angina and heart failure, have a history of hospitalization in 3 months
   • A history of myocardial infarction in the past 6 months
   • There is a need for antibiotic treatment of acute bacterial or fungal infection
   • Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization
   • Drug addiction, alcoholism and AIDS disease or long-term virus carriers
   • Uncontrollable seizures, or loss of insight because of mental illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paclitaxel plus Cisplatin with radiotherapy	Paclitaxel plus Cisplatin with radiotherapy	patients will receive concurrent chemoradiotherapy with drug Paclitaxel plus Cisplatin
S1 plus Cisplatin with radiotherapy	S1 plus Cisplatin with radiotherapy	patients will receive concurrent chemoradiotherapy with drug S1 plus Cisplatin

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	five years after enrollment

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	five years after enrollment