Status:
COMPLETED
Pre-operative Chemo (CPT11, Cisplatin), Radiotherapy, Plus Surgery for Resectable Esophageal Cancer
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Pfizer
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Cancer of the esophagus is a very serious cancer. Studies have shown that using chemotherapy and radiation before surgery is the most promising treatment approach, with one quarter to one half of tumo...
Detailed Description
Historical surgical series have reported that the chance of cure with surgery alone is approximately one in four. Many phase II studies and some phase III studies have examined the role of induction (...
Eligibility Criteria
Inclusion
- Histologically proven squamous or adenocarcinoma or the esophagus \>20 cm from the incisors, including GE junction tumors (unless of gastric origin). GE junction tumors are defined as tumors that have their center within 5 cm proximal and distal of the anatomical cardia
- Clinical T1 N1 M0, T2-3 N0-1 M0, T1-3 N0-1 M1a
- Performance status ECOG 0-2
- Medically fit for chemotherapy, radiation and esophagectomy
- Adequate bone marrow, hepatic and renal function as evidenced by the following:
- Hematology:
- Neutrophils \> 1.5 x 109/L Platelets \> 100 x 109/L
- Hepatic function:
- Total bilirubin \< 1.25x ULN AST (SGOT) and ALT (SGPT) \< 2.5 x ULN Alkaline phosphatase \<2.5 x ULN
- Renal function:
- Serum creatinine \< 160 umol/L or creatinine clearance \> 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows):
- weight (kg) x (140 - age) K x serum creatinine\*
- for serum creatinine in \*mol/L, K=0.814 in man, K=0.96 in woman
- No prior history of malignancy unless \> 5 years disease free, or adequately treated nonmelanotic skin cancer or in situ carcinoma of the cervix
- Tumor technically resectable (as defined in Section 5.4.3)
Exclusion
- In situ or clinical T1N0M0
- Cervical esophageal tumors (within 20 cm of the incisors)
- Positive cytology of the pleura, peritoneum or pericardium
- Supraclavicular lymph node involvement
- Invasion of tracheobronchial tree proven by bronchoscopy including but not limited to tracheo-esophageal fistula
- Prior treatment for this malignancy except esophageal stenting
- Gilbert's disease
- Age \< 18
- Participation in another concurrent clinical study involving study drug(s) or treatment with study drug within thirty days prior to the treatment on this study. Concurrent treatment with other experimental drugs or anticancer therapy
- Known hypersensitivity to either of study drugs or to any of their excipients.
- Pregnant or lactating women. Men and women of reproductive potential (and women \< 12 months after menopause) may not participate unless they have agreed to use an effective contraceptive method while on study
- Known or suspected alcohol or drug abuse
- Other serious or concurrent illnesses that may interfere with subject compliance, adequate informed consent, determination of causality of adverse events and which in the judgement of the Investigator, would make the patient inappropriate for entry into the study
- Life expectancy \< 3 months
- Peripheral neuropathy \> Grade 2 (using CTC Version 2)
- Patients receiving phenytoin or phenobarbital
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00160875
Start Date
April 1 2009
End Date
March 1 2011
Last Update
May 4 2017
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2M9