- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00934518
Image Guided Intensity Modulated Reirradiation (IG-IMRT) With Cetuximab for Locoregionally Confined Recurrent Head and Neck Squamous Cell Carcinoma
Image Guided Intensity Modulated Reirradiation With Concurrent Cetuximab in the Treatment of Locoregionally Confined Relapsed Squamous Cell Carcinoma of the Head and Neck
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Hershey, Pennsylvania, Förenta staterna, 17033
- Penn State Hershey Cancer Institute
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients must have a pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer in the upper aerodigestive tract or a second squamous cell primary. Patients may have experienced more than one recurrence as long as the first recurrence occurred ≥6 months following the end of the prior RT.
- The recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence).
- The majority (≥75%) of the tumor volume must have been in areas previously irradiated to ≥45 Gy. The previous irradiation must not exceed a maximum of 75 Gy.
- Patients must be at least 6 months from prior radiation therapy.
- If a resection is performed after the diagnosis of recurrence and before enrollment, either microscopic or macroscopic disease must be present (i.e. positive margins or gross residual).
- Karnofsky Performance Status 60-100.
- Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, bilirubin ≤ 1.5 mg/dl, creatinine ≤ 1.5 mg/dl, within 6 weeks prior to registration.
- Must be able to submit previous radiation records (simulation and portal film if available) in order to assure that cord tolerance is not exceeded.
- Patients must sign a study-specific informed consent form prior to study entry.
- The patient must be between the ages of 18 and 75.
Exclusion Criteria:
- Distant metastases.
- Completely resected recurrence with negative margins.
- Other concurrent invasive malignancies.
- Prior invasive malignancy unless disease free for at least two years (prior in situ malignancies are permissible).
- Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
- Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
- Previous treatment with cetuximab.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Radiation and Cetuximab
Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week Cetuximab 400 mg/m2 of body surface area over a period of 120 minutes day 1 250 mg/m2 of body surface area over a period of 60 minutes weekly during radiation |
Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week
Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week Cetuximab 400 mg/m2 of body surface area over a period of 120 minutes day 1 250 mg/m2 of body surface area over a period of 60 minutes weekly during radiation |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
To estimate the incidence rate of acute and late toxicities associated with combined cetuximab and image guided intensity modulated reirradiation in patients with recurrent squamous cell cancer of the head and neck.
Tidsram: 5 years
|
5 years
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
To estimate the median and one-year, disease-free, and overall survival rates of the treated patients.
Tidsram: 5 years
|
5 years
|
To determine the pattern of disease progression in treated patients.
Tidsram: 5 years
|
5 years
|
To identify the impact of cetuximab and image guided intensity modulated reirradiation on patients' quality of life.
Tidsram: 5 years
|
5 years
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Heath B Mackley, MD, Penn State Hershey Cancer Institute
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PSHCI 08-066
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