Combination Chemotherapy in Treating Patients With Esophageal Cancer (NCT00041262) | Clinical Trial Compass
UnknownPhase 3
Combination Chemotherapy in Treating Patients With Esophageal Cancer
United Kingdom1,300 participantsStarted 2004-11
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating esophageal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who are undergoing surgery for esophageal cancer.
Who can participate
Sex
ALL
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:
* Histologically confirmed adenocarcinoma of the esophagus or type 1 or 2 tumors of the gastroesophageal junction
* Stage IIB or greater by spiral or multi-slice CT scan and endoscopic ultrasound
* Amenable to primary surgery with curative intent
* No para-aortic/celiac lymphadenopathy greater than 1 cm on CT scan and/or greater than 6 mm on endoscopic ultrasound
* No disease invading the airways, aorta, pericardium, or lung
* No liver, lung, or other distant metastases
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* WHO 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 3,000/mm3
* Platelet count greater than 100,000/mm3
Hepatic:
* Liver function tests no greater than 1.5 times normal
Renal:
* Glomerular filtration rate greater than 60 mL/min
Cardiovascular:
* Ejection fraction greater than 50% OR
* Normal echocardiograph
Pulmonary:
* FEV1 greater than 1.5 L
Other:
* Not pregnant or nursing
* No prior primary malignancy
* No significant medical condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* See Disease Characteristics
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.