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- Klinische proef NCT00369512
A Trial of Erlotinib + Radiotherapy for Cutaneous Squamous Cell Carcinoma (RAD0503)
A Phase II Trial of Erlotinib and Radiotherapy in Patients With Stage III Cutaneous Squamous Cell Carcinomas
Studie Overzicht
Gedetailleerde beschrijving
This is a single-institution, open-label, non-randomized phase II trial of erlotinib administered concomitantly with radiation therapy following surgical resection of gross disease. A total of 45 patients with previously unirradiated, high-risk cutaneous SCC requiring post-operative radiotherapy will be enrolled to assess the primary endpoints of time to recurrence and disease free survival. Pretreatment biopsies will be required to confirm the histological diagnosis of SCC. Four to six weeks after surgical resection, patients will begin erlotinib (150 mg po qd) beginning the first day of radiotherapy. Patients will receive 5040 cGy beginning on day 1 of therapy in standard fractionations. Patients will be followed to evaluate for toxicity based on NCI common toxicity criteria (v3.0). Patients will be followed on protocol for a minimum of 2 years with regularly scheduled CT scans, clinical evaluations, and laboratory work. Patients with residual or recurrent cancer will be taken off protocol for salvage therapy.
As a secondary objective, molecular response of tumors to erlotinib monotherapy will be determined. When possible, participants will be enrolled and treated for 14 days with erlotinib prior to surgical resection. The pretreatment biopsy specimen (control) will then be compared to tissue acquired during the surgical resection after 14 days of erlotinib (experimental group).
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35233
- University of Alabama at Birmingham Medical Center
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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 proven primary or recurrent squamous cell carcinoma arising from the lip or skin of the face, ear, scalp or neck.
- Participants must meet one of the four criteria:
- 1. T4 cutaneous SCC as determined by physical exam, imaging studies, prior resections or biopsy. T4 disease is defined as tumor that invades deep extradermal structures such as cartilage, skeletal muscle (e.g., muscles of facial expression), parotid gland or bone.Patients with a T2 or greater squamous cell carcinoma of the lower lip who will require post operative radiation will be allowed.
- 2. Histologically proven regional lymph node involvement (N1 disease). Fine needle aspiration or biopsy can be used to demonstrate the presence of lymphatic spread.
- 3. Histologically proven parotid gland metastasis. Fine needle aspiration or biopsy can be used to demonstrate the presence of regional spread. Includes delayed regional metastasis; primary scalp or other skin lesion treated within 36 months that would drain into the involved parotid.
- 4. Patients who following surgical resection of the primary are found to have histologically positive lymph nodes (N1). Includes delayed regional metastasis; primary lip or cutaneous lesion treated within 36 months that would drain into the involved nodal basin.
- Age > 19 years
- Tumors must be considered surgically resectable.(Patients may be enrolled after surgery is completed as long as Erlotinib therapy and concurrent radiation is started within 8 weeks of surgical resection.)
- Required laboratory data obtained prior to beginning treatment: WBC > 1,500/ml; Platelets > 90,000; serum creatinine ≤ 2.0 mg/dl
- The patient may have had a prior non-cutaneous malignancy, but must be two years from treatment.
- Performance status of ≤ 2 (ECOG scale) and life expectancy ≥ 12 months.
- The patients must agree to use effective contraception if there is the potential for procreativity. Contraception must be conducted for at least 3 months following the study.
- Patients must sign informed consent
Exclusion Criteria:
- The patient has received prior radiation therapy to the head and neck.
- The patient is pregnant or lactating
- Patients with a prior history of head and neck mucosal cancers.
- Psychological condition that renders the patient unable to understand the informed consent.
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: Erlotinib
Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
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Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments.
Tijdsspanne: 2 years
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Number of gradeable toxicities (via CTCAE manual) experienced by patients on this protocol--number of events
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2 years
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Median Time to Cancer Recurrence
Tijdsspanne: 2 years
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Per protocol, patients were followed every 3 months for recurrent disease by physical exam and imaging (MRI/CT).
Recurrence, in most cases, is detected during routine history/physical exam.
If disease was detected during follow-up, every attempt was made to obtain pathological confirmation of recurrence.
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2 years
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Number of Patients With Recurrence at 2 Years
Tijdsspanne: 2 years
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Rate of recurrence at 2 years.
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2 years
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Eben Rosenthal, M.D., University of Alabama at Birmingham
Publicaties en nuttige links
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
- F060106002
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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