A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
|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 Names:Drug: Oxaliplatin
Other Name: EloxatinRadiation: Radiotherapy
- 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.
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|