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

Mianyang Central Hospital

Status and phase: Unknown; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Other: S1 plus Cisplatin with radiotherapy; Other: Paclitaxel plus Cisplatin with radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02586753

MianyangCH001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Paclitaxel plus Cisplatin with radiotherapy

Experimental group

Description:

patients will receive concurrent chemoradiotherapy with drug Paclitaxel plus Cisplatin

Treatment:

Other: Paclitaxel plus Cisplatin with radiotherapy

S1 plus Cisplatin with radiotherapy

Experimental group

Description:

patients will receive concurrent chemoradiotherapy with drug S1 plus Cisplatin

Treatment:

Other: S1 plus Cisplatin with radiotherapy