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Compares treatment options for Lung Cancer
Official title Study Comparing Two Different Schedules of Radiation for Early-stage Lung Cancer
ClinicalTrials.gov ID: NCT03706027
What this study is testing
- What it's testing
- This study's goal is to find out if the kind of side effects people experience from radiation is different depending on the schedule of their radiation treatment. Patients will be randomly assigned to either the 3 Fraction or 5 Fraction schedule of radiation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histological confirmation of non-small cell cancer will not be required as primary goal of this phase II trial is to look at toxicity. However, all...
- Eligible patients must have appropriate staging studies identifying them as specific subsets of AJCC stage I or II based on only one of the following...
- T1, N0, M0
- T2 (≤ 5 cm), N0, M0
- Patients with hilar or mediastinal lymph nodes ≤ 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with \> 1 cm...
You likely can't join if
- Patients with central tumors. Specifically; central location implies a tumor inside the zone of the proximal bronchial tree defined as a volume 2 cm...
- Evidence of regional or distant metastases after appropriate staging studies.
- Synchronous primary NSCLC.
- Those with prior malignancy in the past 2 years other than non-melanomatous skin cancer or in situ cancer or thyroid cancer.
- Previous lung or mediastinal radiotherapy.
- Plans for the patient to receive concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy...
See the full eligibility criteria
- Histological confirmation of non-small cell cancer will not be required as primary goal of this phase II trial is to look at toxicity. However, all primary non-small cell lung cancers otherwise of following types are...
- Eligible patients must have appropriate staging studies identifying them as specific subsets of AJCC stage I or II based on only one of the following combinations of TNM staging:
- T1, N0, M0
- T2 (≤ 5 cm), N0, M0
- Patients with hilar or mediastinal lymph nodes ≤ 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with \> 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including...
- Zubrod performance status 0-2 within 4 weeks of study entry.
- Women of childbearing potential and male participants must use an effective contraceptive method.
- Evaluations required at time of study entry:
- History \& Physical by a radiation oncologist within 4 weeks of study entry;
- Vitals within 4 weeks of study entry;
- Evaluation by a thoracic surgeon (either via clinical examination and/or input at multidisciplinary tumor board) prior to study entry;
- PFTs: Routine spirometry, lung volumes, diffusion capacity, and arterial blood gases within 8 weeks prior to study entry;
- CT Chest within 6 weeks of study entry (preferably with intravenous contrast, unless medically contraindicated) - to include the entirety of both lungs, the mediastinum, liver, and adrenal glands; primary tumor...
- Whole body positron emission tomography (PET) scan using FDG with adequate visualization of the primary tumor and draining lymph node basins in the hilar and mediastinal regions within 6 weeks prior to study entry.
- Informed consent signed by the subject and a member of the study team.
- Patients with central tumors. Specifically; central location implies a tumor inside the zone of the proximal bronchial tree defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right...
- Evidence of regional or distant metastases after appropriate staging studies.
- Synchronous primary NSCLC.
- Those with prior malignancy in the past 2 years other than non-melanomatous skin cancer or in situ cancer or thyroid cancer.
- Previous lung or mediastinal radiotherapy.
- Plans for the patient to receive concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol.
- Patients with active systemic, pulmonary or pericardial infection.
- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.