A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01732380|
Recruitment Status : Unknown
Verified November 2012 by The First People's Hospital of Lianyungang.
Recruitment status was: Recruiting
First Posted : November 22, 2012
Last Update Posted : November 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Inoperable Esophageal Cancer Stage I-III||Drug: Raltitrexed Drug: Oxaliplatin Radiation: Radiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||July 2013|
Active Comparator: Radiotherapy
Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
Experimental: Raltitrexed/Oxaliplatin Plus 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
Other Name: Eloxatin
- Progression-Free-Survival [ Time Frame: 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.
- Response Rate [ Time Frame: 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.
- Overall survival [ Time Frame: up to 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732380
|Contact: Xiaodong Jiang, Doctoremail@example.com|
|The First People's Hospital of Lianyungang||Recruiting|
|Lianyungang, Jiangsu, China, 222002|
|Contact: Xiaodong Jiang, Doctor firstname.lastname@example.org|
|Study Chair:||Xiaodong Jiang, Doctor||The First People's Hospital of Lianyungang|