Inoperable Esophageal Cancer Stage I-III
Conditions
Brief summary
The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.
Detailed 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.
Interventions
DRUGRaltitrexed
DRUGOxaliplatin
RADIATIONRadiotherapy
Sponsors
The East Hospital of Lianyungang
Donghai People's Hospital
People's Hospital of Ganyu
The First People's Hospital of Lianyungang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free-Survival | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 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. |
Countries
China
Contacts
Primary ContactXiaodong Jiang, Doctor
Outcome results
None listed