Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or S… (NCT00062270) | Clinical Trial Compass
CompletedPhase 1/2
Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
United StatesStarted 2003-05
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Combining chemotherapy and radiation therapy with gefitinib before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase I/II trial to compare the effectiveness of neoadjuvant chemoradiotherapy with or without gefitinib in treating patients who are undergoing surgery for stage III non-small cell lung cancer.
Who can participate
Age range
19 Years – 120 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 or cytologically confirmed non-small cell lung cancer
* Stage IIIA (T1-3, N2)
* Positive (pathological) ipsilateral mediastinal node
* Selective stage IIIB meeting all of the following criteria:
* No pleural/pericardial effusion or superior vena cava syndrome
* T4 due to invasion of carina, trachea, or mediastinal structures
* Mediastinal N3 nodes (without supraclavicular or cervical adenopathy)
* Proof of N2 or N3 status requires surgical staging of the mediastinum (mediastinoscopy, mediastinotomy, or exploration)
* Expression of epidermal growth factor receptor (at least 1+) by immunohistochemistry
* Measurable disease by contrast CT scan allowed
* No bronchoalveolar cell carcinoma
* No prior diagnosis of lung cancer
PATIENT CHARACTERISTICS:
Age
* 19 and over
Performance status
* ECOG 0-1 (0-2 if albumin is at least 0.85 times lower limit of normal and weight loss within 3 months before diagnosis is no greater than 10%)
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 150,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic
* Bilirubin normal
* AST and ALT no greater than 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2 times ULN
* Alkaline phosphatase between 1.5-2 times ULN requires a negative bone scan for metastatic bone disease
Renal
* Creatinine no greater than 1.4 mg/dL OR
* Creatinine clear…
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
Determine the tolerability and toxicity of gefitinib in combination with chest radiotherapy in patients with stage IIIA or stage IIIB non-small cell lung cancer.