Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus (NCT00002883) | Clinical Trial Compass
CompletedPhase 3
Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
France250 participantsStarted 1996-10
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with surgery is more effective than surgery alone.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients with cancer of the esophagus.
Who can participate
Age range0 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Adenocarcinoma of the lower third of the esophagus or the cardia for which complete resection is feasible
* Extension to the cardia allowed
* Cancer of the cardia with extension to the esophagus or stomach allowed
* No in situ cancer of the cardia
* No distant metastases
PATIENT CHARACTERISTICS:
Age:
* Not over 75
Performance status:
* WHO 0 or 1
Hematopoietic:
* WBC at least 4,000
* Polymorphonuclear lymphocytes greater than 2,000
* Platelets at least 100,000
Hepatic:
* Not specified
Renal:
* Creatinine less than 1.3 mg/dL (120 micromoles/L)
Cardiovascular:
* No prior myocardial infarction
* No other cardiac contraindication to surgery
Pulmonary:
* No respiratory contraindication to surgery
Other:
* No second malignancy except:
* Basal cell carcinoma of the skin
* Adequately treated in situ carcinoma of the uterine cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for tumors of the cardia
Endocrine therapy
* No prior radiotherapy for tumors of the cardia
Radiotherapy
* Not specified
Surgery
* Not specified