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Dosejustert kjemoradioterapi ved HPV-assosiert orofarynx-kreft hos eldre ((DACHOC-E))

28. september 2026 oppdatert av: Omar Mahmoud

Pilotforsøk med dosejustert kjemoradioterapi ved HPV-assosiert orofarynx-kreft hos eldre (DACHOC-E)

Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less.

For this reason this study is looking at a different regimen of reducing the intensity of the treatment.

The purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects.

Studieoversikt

Detaljert beskrivelse

There will be about 30 people taking part in this study. This study has one study group. All the people on the study will receive radiation therapy once a day, 5 days a week (for a total of 55 Gy over 5 weeks) and chemotherapy, cisplatin, (given through the vein for about 30-60 minutes) once a week for 5 weeks.

Medications and saline solutions to prevent side effects of chemotherapy may also be given by vein and may prolong your time in the chemotherapy clinic to as much as 4-6 hours.

Standard regimen not delivered on this study pertains to radiation therapy and chemotherapy, cisplatin in a schedule of 5 treatments a week for a total of 69.96 Gy over 6.5 weeks.

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år til 99 år (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)
  • Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
  • P16-positive based on local site immunohistochemical tissue staining
  • Clinical stage T1-3, N1-2, M0 (AJCC, 8th ed.)
  • Age ≥ 65.
  • Normal organ and marrow function within 14 days prior to registration defined as follows:
  • Absolute neutrophil count ≥ 1,500/mcL
  • Platelets ≥ 100,000/mcL
  • Hemoglobin ≥ 8.0 g/dL
  • Total bilirubin ≤ 1.5× institutional upper limit of normal (ULN)
  • AST(SGOT) or ALT(SGPT) ≤ 3.0 × institutional ULN
  • Serum creatinine ≤ 1.5× ULN

Exclusion Criteria:

  • Metastatic disease
  • Recurrent disease after primary management Cancers with center of mass is outside the oropharyngeal boundaries
  • Synchronous double primaries
  • Prior radiotherapy for lymphoma or other malignancy
  • Prior systemic therapy including immunotherapy
  • Severe active comorbidity where life expectancy is <1 year.
  • Autoimmune disease
  • Uncontrolled HIV

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Experimental

Cisplatin: 30-40 mg/m2/week, every week during radiation. Dose should be based on actual body weight. The first cisplatin infusion should be started within 24 hours before or after the first scheduled radiation treatment.

Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT) are mandatory for this study.

55 Gy radiation in 5 weeks using 5 fractions per week + Cisplatin every week

Instead of standard bilateral or extensive neck fields, the current radiation fields will cover disease with only 3cm expansion. The clinical target volumes doses are biologically equivalent to the standard but given in a shorter hypofractionated approach.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Two-year progression free survival
Tidsramme: 2 years

Assuming the primary endpoint (non-inferior 2 year locoregional control) is met and both of these toxicity outcome goals are met, then concurrent short course radiotherapy would be considered an effective and less toxic alternative to concurrent standard arm, in locally advanced HPV-associated carcinoma of the oropharynx.

2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Benefit and Tolerance of Treatment
Tidsramme: 2 years

Frailty index G8 score 14 as major determinant of benefit and tolerance to treatment through:

Per prior study score <14 (1-17) is an indicator of frailty. The frailty as a factor in completing therapy (yes or no) and number of days break from therapy will be used as a variable.

G20 frailty index (G-20 is the actual name and not abbreviation) is as follows:

A Has food intake declined over the past 3 months due to loss of appetite, digestive problems, chewing or swallowing difficulties? B Weight loss during the last 3 months C Mobility D Neuropsychological problems E Body Mass Index (BMI (weight in kg) / (height in m²) F Takes more than 3 medications per day G In comparison with other people of the same age, how does the patient consider his/her health status? H Age

2 years
Acute Toxicity
Tidsramme: 2 years

Acute toxicity (Grade 3 or higher)

2 years
Late toxicity
Tidsramme: 2 years

Late toxicity (Grade 3 or higher)

2 years
Failure pattern
Tidsramme: 2 years

Pattern failure (local in field, local marginal miss, local regional failure, distant failure, combination of the above).

As some of the patient may have recurrence in the radiation fields, this will be termed local recurrence. Recurrence outside the radiation fields but in the head and neck area will be quantified as regional failure. Failure outside the head and neck area will be classified as distant failure. This outcome will be quantified as global number of failure out of the 20 patients and their distribution will be quantified in a diagram as explain above.

2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. desember 2025

Primær fullføring (Antatt)

30. september 2027

Studiet fullført (Antatt)

30. september 2027

Datoer for studieregistrering

Først innsendt

22. februar 2024

Først innsendt som oppfylte QC-kriteriene

6. mars 2024

Først lagt ut (Faktiske)

13. mars 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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