Sequential Paclitaxel Plus Cisplatin Chemotherapy and Radiotherapy as 1st Line Treatment for Esophageal Squamous Cell Cancer

Phase 2

• Conditions: Esophageal Squamous Cell Cancer
• Interventions: Other: Sequential chemotherapy (paclitaxel 175mg/m2 d1; cisplatin 37.5mg/m2 d1,d2) and radiotherapy

• Registration Number: NCT02016274
• Lead Sponsor: Shen Lin

Brief Summary

Metastatic esophageal squamous cell carcinomas have poor prognosis and majority of patients resistant to chemotherapy in China. In the investigators phase II clinical trial proceeded before, the combination of paclitaxel with cisplatin showed good tolerance and efficacy to esophageal squamous cell carcinomas. Radiotherapy has been indicated as a definitive treatment for unresectable or medically inoperable tumors in ESCC patients. However, not only the combination with chemotherapy, but also the boundaries of the clinical target volume (CTV) are not internationally defined. The investigators then initiated a prospective phase II clinical trial with sequential paclitaxel/cisplatin and radiotherapy as the 1st line treatment in metastatic esophageal carcinoma to observe the efficacy and safety of the combination.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-12
• Study Start: 2013-12
• Study First Submitted: 2013-12-07
• Study First Submitted QC: 2013-12-13
• Last Update Submitted: 2013-12-13
• Study First Posted: 2013-12-19
• Last Update Posted: 2013-12-19
• Primary Completion: 2015-12
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Having signed informed consent
• Age ≥18 years old
• Histologically confirmed esophageal squamous carcinoma,metastatic disease with primary tumor,no prior palliative chemotherapy; No prior radiotherapy except radiotherapy at non-target lesion of the study more than 3 months
• Sex is not limited
• Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
• Karnofsky performance status ≥80
• Life expectancy of ≥ 3 month
• WBC > 3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet > 100,000/mm3, Hb > 9g/dl(within 14 days before enrollment),ALT and AST < 2.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level < 1.0 times ULN,Serum AKP < 2.5 times ULN,Serum creatinine < 1.5 times ULN
• No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever > 38℃；
• Normal ECG and heart function
• Fertile patients must use effective contraception
• Good compliance

Exclusion Criteria

• Previous treatment of palliative chemotherapy
• Known hypersensitivity to Paclitaxel,Cisplatin
• Only with Brain or bone metastasis
• No measurable lesions, eg. pleural fluid and ascites
• Suffer from severe heart disease or disease with other important organs
• Chronic diarrhea or renal dysfunction
• Pregnancy or lactation period
• Other previous malignancy within 5 year, except non-melanoma skin cancer Chronic diarrhea
• Mentally abnormal or disable cognition,including CNS metastasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sequential treatment	Sequential chemotherapy (paclitaxel 175mg/m2 d1; cisplatin 37.5mg/m2 d1,d2) and radiotherapy	paclitaxel/cisplatin treatment and radiotherapy

Primary Outcome Measures

Name	Time	Method
progression free survival	1 year	the follow-up visit of PFS will be performed every 2 cycles

Secondary Outcome Measures

Name	Time	Method
overall survival	2 years	OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China