Status:
COMPLETED
Perioperative Vs. Preoperative Chemotherapy With Surgery in the Squamous Carcinoma of Esophagus
Lead Sponsor:
Xi'an Jiaotong University
Conditions:
Squamous Carcinoma of Esophagus
Esophagus Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To assess whether or not a perioperative therapy with surgery can improve the outcomes among patients with potentially curable squamous carcinoma of esophagus as compared to a preoperative chemotherap...
Detailed Description
Perioperative chemotherapy has been shown to significantly improve the R0 resection rate, the disease free survival and the overall survival in patients with adenocarcinoma of the esophagus, the gastr...
Eligibility Criteria
Inclusion
- Signed informed consent
- histologically confirmed esophageal cancer (squamous carcinoma) measurable, non-metastatic disease
- no previous cancer therapy (chemotherapy, radiotherapy or resection)
- life expectancy \> 3 months
- age \> 18 years
- WHO Status ≤ 1
- Intended curative resection according to evaluation of an experienced surgeon
- Negative pregnancy blood test at screening but not earlier than 72 hours prior to start of chemotherapy for women with child bearing potential
- Adequate haematologic function and liver and renal function: neutrophils \> 1.5×109/L; thrombocytes \> 100×109/L; haemoglobin \> 10 g/dl, creatinine clearance \> 60 ml/min (calculated according to Cockroft and Gault), total bilirubin \< 1.0×UNL; AST and ALT \< 1.5×UNL, AP \< 2.5×UNL
- Complete staging within 3 weeks prior to start of treatment (CT-scan of thorax and abdomen, endosonography, gastroscopy)
- Ability to keep appointments and follow the study protocol
- By CT-scan, endoscopy or endosonography measurable or evaluable disease
Exclusion
- Former therapy of cancer (operation, chemo- or radiotherapy)
- Diagnosis of another cancer in the last 5 years prior to study entry which has not been cured by operation only (exception in-situ-carcinoma of the cervix or cured non-melanomatose skin cancer)
- Known contraindication to the planned chemotherapeutics
- Presence of distant metastases
- Anamnestic known serious disease or other concomitant diseases that affect participation in this study, such as:
- oInstable cardiac disease: symptomatic heart failure, symptomatic coronary artery disease, ventricular cardiac arrhythmia not well controlled with medication, myocardial infarction or resuscitation within 6 month before study oActive infection necessitating systemic therapy or uncontrolled infection oInterstitial lung diseases (for example: pneumonitis or fibrosis of the lung) and indication for interstitial lung disease in chest x-ray or CT-scan respectively oActive inflammatory bowel disease or other bowel diseases which provoke chronic diarrhea (defined as \> 4 bowel movements per day) oNeurological or psychiatric disease including dementia, epilepsy or untreated, symptomatic brain metastases oLimited hearing ability
- Presence of upper GI obstruction, leading to inability to swallow ground tablets
- Presence of acute or chronic systemic infection
- Presence of a bowel obstruction within the last 30 days
- Pregnant or lactating women or women with child bearing potential and men without adequate contraception (high effective contraception, defined as Pearl Index \< 1) like birth control pill, hormone spiral, hormone implant, transdermal patch, a combination of two barrier methods (condom and diaphragm), realized sterilization or sexual abstinence during the study and at least for 3 months after the last infusion
- Any other situation which may lead to an unacceptable high risk for the patient, when he participates in the study
- Parallel treatment in another clinical study or prior participation in this study
- Treatment with any other therapy against the tumor or any parallel radiation
- Symptomatic peripheral neuropathy NCI-CTCAE degree \> 2
- Intolerance to the study medication
- Detention in a psychiatric unit or imprisonment
Key Trial Info
Start Date :
January 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT01225523
Start Date
January 1 1997
End Date
January 1 2010
Last Update
October 21 2010
Active Locations (1)
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1
First Affiliated Hospital of College of Medicine of Xi'an Jiao Tong University
Xi'an, Shaanxi, China, 710061