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- Klinische proef NCT01820312
A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT)
A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT) and Chemotherapy in Recurrent and Inoperable Squamous Cell Carcinoma (SCC) of the Head and Neck After Radiotherapy Failure
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
This study will evaluate a combination therapy of paclitaxel and LDFRT. The paclitaxel will be commercially available drug product dispensed by a licensed pharmacist at UAMS. Radiotherapy will be delivered using either the TomoTherapy Treatment System (TomoTherapy, Inc.) or the Varian High Energy Linear Accelerator (Varian Medical Systems).
Subjects will undergo CT imaging (to include neck, chest, abdomen and pelvis) as part of the standard of care approximately 7 to 21 days prior to initiation of this therapy. Additional CT imaging will be done at UAMS approximately 3 months after completion of protocol therapy and every 3 months subsequently until progression or completion of the study whichever comes first. These CT imaging's will be obtained for recurrent tumor evaluation and determination of the presence or absence of distant metastasis, as part of the standard of care.
Studietype
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Arkansas
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Little Rick, Arkansas, Verenigde Staten, 72205
- University of Arkansas for Medical Sciences
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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:
- Subject 18 years of age and older, male or female, of all races and ethnicities.
- Subject with prior histologically confirmed advanced squamous-cell carcinoma of the head and neck that failed prior traditional chemoradiotherapy with at least a 3-month disease-free interval from the completion of the initial curative treatment.
- Recurrence must have been confirmed via biopsy.
- Subject must have an ECOG performance status of 0, 1 or 2.
- Has undergone CT imaging within 21 days prior to treatment as part of routine care.
- Measurable disease by CT.
- Subject deemed likely to survive for at least 6 months.
- Subject is able and willing to provide written informed consent to participate in the study.
- If the subject is a female of childbearing age, the subject should have a negative urine pregnancy test and be practicing strict birth control (estrogen-containing oral contraceptives or an intrauterine device) throughout the study and for 3 months after completion of protocol treatment. Women who have had a hysterectomy are exempt from these requirements. This is routine for any patient undergoing treatment.
- History of laboratory criteria as specified below (within 21 days prior to enrollment) Hemoglobin ≥ 9 g/dl Platelet count >100,000 per microliter CO2 (carbon dioxide): 22-32 meq/L Creatinine: < 1.5 mg/dL or eGFR>40 ml/min Serum bilirubin <1.6 mg/dl. White blood count > 3,000 per microliter or ANC > 1500 per microliter Serum calcium <10.5 mg/dl.
Exclusion Criteria:
- The tumor is not clearly shown on diagnostic imaging studies
- Subject is pregnant.
- Subject with known allergies/hypersensitivity to paclitaxel.
- Subjects with poor renal function as demonstrated by serum creatinine (>1.5 mg/dl) and EGFR <40 mL/min, which would preclude the using of image contrast agents.
- Subject with a planned surgical procedure within the next 30 days.
- Subject has distant metastasis (with the exception of single stable distant metastasis that does not decrease life expectancy to less than 6 months).
- Subject is of childbearing potential and will not use adequate contraceptive protection.
- Subject who is breastfeeding.
- Subject of childbearing potential who has a positive (+) urine pregnancy test.
- Subject has received treatment with an experimental drug or entered another clinical trial within the prior 30 days.
- Subject has received radiotherapy to the head and neck region within the prior 3 months.
- Subject is not willing or able to complete the visit requirements of this protocol.
- Peripheral neuropathy of any etiology.
- Any other condition that the PI feels will be an endangerment to the subject.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Objective Response (OR)
Tijdsspanne: OR will be determined in each subject 3 months following therapy using CT imaging performed for clinical-care purposes
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Objective Response (OR).
OR will be defined according to RECIST v1.1 criteria as either a complete or partial response.
OR will be determined in each subject 3 months following therapy using CT imaging performed for clinical-care purposes.
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OR will be determined in each subject 3 months following therapy using CT imaging performed for clinical-care purposes
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jose Penagaricano, MD, University of Arkansas
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 (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata per site
- Neoplasmata, glandulair en epitheel
- Hoofd- en nekneoplasmata
- Neoplasmata, plaveiselcel
- Carcinoom
- Carcinoom, plaveiselcel
- Plaveiselcelcarcinoom van hoofd en hals
- Moleculaire mechanismen van farmacologische werking
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, fytogeen
- Paclitaxel
Andere studie-ID-nummers
- 136191
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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Klinische onderzoeken op Low-Dose Fractionated Radiation Therapy/Paclitaxel
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