Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer
A Study of Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer
Patients with metastatic cancer are generally treated with chemotherapy, which has improved median survival compared to best supportive care. Despite this, patients continue to have persistent disease at sites that were initially involved with cancer. Radiation therapy is an effective modality for treating localized cancer but generally has been only used for palliation of symptoms once a patient develops metastatic disease. Since patients often have persistent disease after chemotherapy, the goal of this trial is to use increasing doses of radiation therapy to all sites of involved disease in order to determine the safety and efficacy of hypofractionated radiation therapy.
The purpose of this study is to establish a maximum tolerated dose, dose-limiting toxicities, and recommended phase 2 dose of hypofractionated radiation therapy.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Illinois
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Chicago, Illinois, Verenigde Staten, 60637
- University of Chicago
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of cancer (including epithelial carcinoma, sarcoma, and melanoma)
- Age 18 years and older
- Life expectancy of > 3 months
- Patients with AJCC (6th edition, 2002) stage IV cancer with distant metastases and without pleural or pericardial effusion at diagnosis and before start of study
- Patients with 1-5 sites of maximum tumor dimension (for each individual site) of ≤ 10 cm or < 500 cc volume and amenable to radiation therapy as seen on standard imaging
- Unidimensionally measurable disease (based on RECIST) is desirable but not strictly required
- Brain metastases must have been treated prior to enrollment on study, preferably with stereotactic radiosurgery
- ECOG performance status ≤ 2 or Karnofsky Performance Status ≥ 60%
- No prior radiation therapy to currently involved tumor sites
- Room air saturation > 90%
- Hemoglobin > 9.0 g/dl
- ANC >=1,500/microliter
- Platelets >=100,000/microliter
- Total bilirubin within institutional limits
- Albumin > 2.9 g/dl
- Alkaline phosphatase < 2.5x upper limit of normal
- AST and ALT < 2.5 x upper limit of normal
- Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
- Uncontrolled intercurrent illness
- Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. Exclusion of patients with active coronary heart disease will be at the discretion of the attending physician
- Patients with significant atelectasis such that CT definition of gross tumor volume is difficult to determine
- Pregnancy or breast feeding
- Patients must have no uncontrolled active infection other than that not curable with treatment of their cancer.
- Patients may not be receiving any other investigational drugs during RT
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Bestralingstherapie
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RT to site of metastatic disease for three fractions separated by 3 to 8 days. Doses of radiation will increase as follows in order to determine the MTD in Gy: For all sites the dose levels are as follows:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Dose-limiting toxicities
Tijdsspanne: 30-90 days
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The dose limiting toxicities occurring within the initial observation period will be defined.
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30-90 days
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maximum tolerated dose of hypofractionated RT
Tijdsspanne: 30-90 days
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30-90 days
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 13619B
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