A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer

Phase 2

• Conditions: Inoperable Esophageal Cancer Stage I-III
• Interventions: Radiation: Radiotherapy; Drug: Raltitrexed; Drug: Oxaliplatin

• Registration Number: NCT01732380
• Lead Sponsor: The First People's Hospital of Lianyungang

Brief Summary

The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.

Detailed Description

108 patients were randomized to receive Raltitrexed/Oxaliplatin Plus Radiotherapy (Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks.)or Radiotherapy ( Radiotherapy 2.0Gy/day, 5 times/week,6 weeks) in subjects with Inoperable esophageal cancer. All patients will receive therapy of six weeks unless disease progression or unacceptable toxicity. Patients were evaluated every 3 months .Progression-Free-Survival was the primary endpoint. Response Rate, Overall survival, toxicity of the therapy are other second endpoint.

Study Timeline

• Study Start: 2012-07
• Status Verified: 2012-11
• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-19
• Last Update Submitted: 2012-11-19
• Study First Posted: 2012-11-22
• Last Update Posted: 2012-11-22
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Confirmed diagnosis of inoperable esophageal cancer(squamous cell carcinoma)
• Measurable disease according to RECIST criteria
• Age > 18 years
• WHO performance score < 2
• Estimated life expectancy of > 12 weeks
• Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
• Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
• Renal function: Cr ≤ 1.25×UNL
• Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
• Documented informed consent to participate in the trial

Exclusion Criteria

• Subjects with distant metastases
• Pregnancy or breast feeding. Women of childbearing age must use effective contraception
• Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
• Evidence of bleeding diathesis or serious infection
• pregnant or lactating woman
• Patient participation in other studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy	Radiotherapy	Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
Raltitrexed/Oxaliplatin Plus Radiotherapy	Raltitrexed	Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
Raltitrexed/Oxaliplatin Plus Radiotherapy	Oxaliplatin	Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
Raltitrexed/Oxaliplatin Plus Radiotherapy	Radiotherapy	Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer

Primary Outcome Measures

Name	Time	Method
Progression-Free-Survival	up to 2 years	Progression-free survival (PFS) is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse.

Secondary Outcome Measures

Name	Time	Method
Response Rate	up to 2 years	Response rate (RR) is a figure representing the percentage of patients whose cancer shrinks (termed a partial response, PR) or disappears after treatment (termed a complete response, CR) . In simpler terms RR=PR+CR.

Trial Locations

Locations (1)

The First People's Hospital of Lianyungang; 🇨🇳 Lianyungang, Jiangsu, China