A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
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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
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Radiotherapy
Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
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Radiation: Radiotherapy |
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
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Drug: Raltitrexed
Other Names:
Drug: Oxaliplatin Other Name: Eloxatin Radiation: 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.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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, Doctor | 86-0518-85469074 | jxdysy1970@163.com |
China, Jiangsu | |
The First People's Hospital of Lianyungang | Recruiting |
Lianyungang, Jiangsu, China, 222002 | |
Contact: Xiaodong Jiang, Doctor jxdysy1970@163.com |
Study Chair: | Xiaodong Jiang, Doctor | The First People's Hospital of Lianyungang |
Responsible Party: | The First People's Hospital of Lianyungang |
ClinicalTrials.gov Identifier: | NCT01732380 |
Other Study ID Numbers: |
1stPeopleLianyungang |
First Posted: | November 22, 2012 Key Record Dates |
Last Update Posted: | November 22, 2012 |
Last Verified: | November 2012 |
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |
Oxaliplatin Raltitrexed Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Enzyme Inhibitors |