A Phase 2 interventional study of Raltitrexed and Oxaliplatin in Inoperable Esophageal Cancer Stage I-III, sponsored by The First People's Hospital of Lianyungang. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-11-22.
Sponsored by The First People's Hospital of Lianyungang · Phase 2, Interventional, and Treatment
The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.
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.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's planned enrollment of 108 is above the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →The First People's Hospital of Lianyungang is the lead sponsor of 20 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
Radiation: 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
Drug: Raltitrexed · Drug: Oxaliplatin · Radiation: Radiotherapy
Also known as: TOMUDEX, Sai Wei Jian
Also known as: Eloxatin
Progression-Free-Survival
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.
Time frame: up to 2 years
Response Rate
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.
Time frame: up to 2 years
Overall survival
People in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease, such as cancer. The overall survival is often stated as a five-year survival, which means people in a study or treatment group who are alive five years after their diagnosis or the start of treatment.
Time frame: up to 2 years
This study is status unknown, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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The First People's Hospital of Lianyungang