Perioperative Vs. Preoperative Chemotherapy With Surgery in the Squamous Carcinoma of Esophagus

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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 chemotherapy followed by surgery

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Health Science Center of Xi'an Jiaotong University; Health Science Center of Xi’an Jiaotong University
• Treatments: Albumin-Bound Paclitaxel; Capecitabine; Cisplatin; Fluorouracil; Paclitaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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