Fluorouracil, Cisplatin, Leucovorin Calcium, and Cetuximab in Treating Patients With Adenocarcino… (NCT01360086) | Clinical Trial Compass
CompletedPhase 2
Fluorouracil, Cisplatin, Leucovorin Calcium, and Cetuximab in Treating Patients With Adenocarcinoma of the Stomach or Gastroesophageal Junction
France65 participantsStarted 2011-06
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving more than one drug (combination chemotherapy) together with cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects of giving fluorouracil, cisplatin, and leucovorin calcium together with cetuximab and to see how well they work in treating patients with adenocarcinoma of the stomach or gastroesophageal junction.
Who can participate
Age range
18 Years – 75 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 adenocarcinoma of the stomach or gastroesophageal junction
* Stage IB, II, or III disease according to TNM classification OR type I, II, or III disease according to Siewert classification
* TNM: T1N1-3, T2N0-3, T3N0-3, or T4N0-3 (no T1N0 or M1)
* Disease considered operable with curative intent
* No gastric scirrhous carcinoma (linitis plastica)
* Forms with independent cells are not considered linitis
* Measurable disease according to RECIST V1.1
* No planned esophagectomy without thoracotomy in patients with adenocarcinoma of the gastroesophageal junction type I
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Polynuclear neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine clearance \> 50 mL/min
* Bilirubin \< 1.5 times normal
* Serum albumin \> 30 g/L
* Prothrombin time ≥ 80%
* FEV1 \> 1 L in case of thoracotomy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known cirrhosis
* No other progressive condition that has not been stabilized including the following:
* Hepatic failure
* Renal failure
* Respiratory failure
* NYHA class III-IV congestive heart failure
* Unstable angina
* Myocardial infarction in the past 6 months
* Significant arrhythmias in the past 12 months
* No recent weight loss exceeding 15%
* No interstitial pneumonia
* No other malignant tumor within the past 5 years except for basal cell…
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.
What they're measuring
1
Objective response rate according to RECIST V1.1 criteria
Timeframe: 3 months
2
Non-toxicity rate
Timeframe: 3 months
Trial details
NCT IDNCT01360086
SponsorFederation Francophone de Cancerologie Digestive