Cisplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients Wit… (NCT00509561) | Clinical Trial Compass
UnknownPhase 2/3
Cisplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients With Esophageal Cancer
United Kingdom259 participantsStarted 2008-02
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and capecitabine, work in different ways to kill tumor cells or stop them from growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving cisplatin together with capecitabine and radiation therapy is more effective with or without cetuximab in treating esophageal cancer.
PURPOSE: This randomized phase II/III trial is studying the side effects and how well giving cisplatin together with capecitabine, radiation therapy, and cetuximab works compared with giving cisplatin, capecitabine, and radiation therapy without cetuximab in treating patients with esophageal cancer.
Who can participate
Age range
18 Years
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 carcinoma of the esophagus
* Adenocarcinoma
* Squamous cell
* Undifferentiated carcinoma
* Siewert type I tumor of the gastroesophageal junction
* Localized, nonmetastatic disease (T1-4, N0-1) confirmed by endoscopic ultrasound (EUS) and spiral CT scan
* Total disease length (primary and lymph nodes) \< 10 cm by EUS
* Not suitable for surgery (either for medical reasons or patient's choice)
* No metastatic disease (i.e., M1a or M1b according to UICC TNM version 6)
* No significant (\> 2 cm) extension of tumor into the stomach
PATIENT CHARACTERISTICS:
* WHO performance status 0-1
* Absolute neutrophil count ≥ 1,500/mm³
* White blood cell count ≥ 2,000/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 10 g/dL (should be corrected to \> 10 g/dL before treatment)
* Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT/AST ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 3 times ULN
* Glomerular filtration rate \> 40 mL/min OR \> 60 mL/min estimated by Cockcroft-Gault formula
* Adequate cardiac ejection fraction ≥ 40% by MUGA or ECHO
* FEV\_1 ≥ 1 L by spirometry
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No malignancy within the past 5 years
* No unstable angina, uncontrolled hypertension, cardiac failure, or other clinically significant cardiac disease
* No major trauma within the past 4 weeks
* No known dihydropyrimidine dehydrogenase deficiency
* No hearing impair…
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.