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

The First People's Hospital of Lianyungang

Status and phase: Unknown; Phase 2

Conditions: Inoperable Esophageal Cancer Stage I-III

Treatments: Drug: Raltitrexed; Radiation: Radiotherapy; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01732380

1stPeopleLianyungang

Details and patient eligibility

About

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

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Radiotherapy

Active Comparator group

Description:

Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer

Treatment:

Radiation: Radiotherapy

Raltitrexed/Oxaliplatin Plus Radiotherapy

Experimental group

Description:

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

Treatment:

Radiation: Radiotherapy

Drug: Oxaliplatin

Drug: Raltitrexed