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JOURNAL ONKOLOGIE – STUDIE
DELPHI

De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas

Rekrutierend

NCT-Nummer:
NCT03396718

Studienbeginn:
September 2018

Letztes Update:
11.09.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Technische Universität Dresden

Collaborator:
German Cancer Research Center, National Center for Tumor Diseases (NCT) Dresden, National Center for Tumor Diseases, Heidelberg, Radiation Oncology Working Group of the German Cancer Society,

Studienleiter

Mechthild Krause, Prof.
Study Chair
University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)

Kontakt

Mechthild Krause, Prof.
Kontakt:
Phone: +49 351 458 2238
E-Mail: mechthild.krause@uniklinikum-dresden.de» Kontaktdaten anzeigen

Studienlocations
(3 von 9)

Prof. Anca-Ligia Grosu
79106 Freiburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Anca-Ligia Grosu, Prof.
Phone: +49 761 270 94610
E-Mail: anca.grosu@uniklinik-freiburg.de» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

For all patients taking part in the study the HPV status of the resected tumor will be

determined centrally by p16 immunohistochemistry and confirmation will be done by HPV DNA

assessment using Polymerase Chain Reaction (PCR)-based array. Patients positive for HPV will

be treated with a reduced RT dose to the tumor and to elective neck. HPV negative patients

will be treated with standard radio- or radiochemotherapy. Patients deemed at high risk for

locoregional recurrences (presence of extracapsular spread, residual tumor or multiple

affected nodes) will be treated separately from patients deemed at intermediate risk (T>=3,

and / or 1-3 nodes positive). The high risk group will be treated with a higher dose and

concurrent chemotherapy. After inclusion of 30 patients per treatment group, follow up for

the patients will be awaited for two years and safety of the intervention will be assessed.

The second de-escalation level will only be opened for accrual if not more than three

locoregional recurrences will occur per treatment group.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Condition after surgical removal of a squamous cell carcinoma of the oropharynx and

adequate lymph node dissection

- Indication for adjuvant radiotherapy or radiochemotherapy in the interdisciplinary

tumor board

- Good general state (ECOG performance status 0 or 1)

- Adequate compliance to ensure closely follow-up

- Patient's consent and written consent

- Neck dissection of at least the tumor bearing side

Additional Inclusion Criteria Arm intermediate risk (at least one of the criteria must be

fulfilled):

- pT3 and R0 and / or

- histologically confirmed involvement of lymph nodes (n = 1-3) and no extracapsular

extension of the lymph node metastasis

Additional Inclusion Criteria Arm high risk (at least one of the criteria must be

fulfilled):

- residual tumor (R1 status) and / or

- pathologic stage T4 (pT4) status and / or

- more than 3 infected lymph nodes and / or

- extracapsular extension of at least one lymph node metastasis

Exclusion Criteria:

- Patients with a cumulative nicotine abuse > 30 packyears. These patients are not

included in the intervention arms, but are always included in the observation arms

(regardless of HPV status).

- radiologically presumed or histologically confirmed distant metastasis

- R2 resection or macroscopically visible residual tumor after surgery

- no neck dissection

- interval between last operation and planned irradiation start > 7 weeks

- contraindication against a guideline-appropriate adjuvant radiation or

radiochemotherapy according to the clinical risk constellation

- tumor disease in the last five years before the beginning of the study (except

basaliomas of the skin, in-situ carcinoma of the cervix uteri or breast, or tumors

with similar prognosis which are considered to be very likely to be cured)

- malignant tumor disease in the head and neck region, regardless of interval and

prognosis

- Pre-irradiation with risk of dose overlap

- participation in another clinical trial if further experimental therapy is necessary

or the treatments/ protocols are mutually exclusive (e.g. altered chemotherapy,

additional consolidation chemotherapy). Allowed is the additional participation in

observation studies or supportive therapy studies.

- diseases or conditions which do not allow the person concerned to assess the nature

and scope and possible consequences of the clinical trial

- pregnant or lactating women

- evidence that the participant is not expected to comply with the study protocol (e.g.

lack of cooperation)

- missing written consent

Studien-Rationale

Primary outcome:

1. rate of locoregional recurrences (Time Frame - 24 months after end of treatment):
measured from the last day of treatment



Secondary outcome:

1. overall survival (Time Frame - 60 months and 5 years after end of treatment):
measured from the last day of treatment

2. acute toxicity (Time Frame - 3 months after end of treatment):
The occurrence of acute side effects (up to 90 days after start of treatment) will be recorded and documented based on CTCAE 4.0.

3. late toxicity (Time Frame - 24 months after end of treatment):
The occurrence of late side effects will be recorded and documented based on CTCAE 4.0 after every follow-up visit.

4. quality of life of cancer patients (Time Frame - 24 months after end of treatment):
The assessment of quality of life (QoL) is carried out using the EORTC quality of life questionnaire (QLQ) C30. Quality of life will be documented immediately before the start of therapy, after completion of postoperative radiotherapy and at every follow-up visit. QOL will be measured as change from baseline over time.

5. quality of life - disease specific (Time Frame - 24 months after end of treatment):
The assessment of quality of life (QOL) is carried out using the EORTC quality of life questionnaire (QLQ) disease-specific module for head and neck cancer H&N35. Quality of life will be documented immediately before the start of therapy, after completion of postoperative radiotherapy and at every follow-up visit. QOL will be measured as change from baseline over time.

6. rate of locoregional recurrences (Time Frame - 5 years after end of treatment):
measured from the last day of treatment

Studien-Arme

  • Experimental: Interventional Arm A - HPV(+)
    De-escalation Radio(chemo)therapy - Level 1
  • Experimental: Interventional Arm B - HPV(+)
    De-escalation Radio(chemo)therapy - Level 2
  • Active Comparator: Observational Arm A - HPV(-)
    Standard Radio(chemo)therapy
  • Active Comparator: Observational Arm B - HPV(+)
    Standard Radio(chemo)therapy

Geprüfte Regime

  • De-escalation radio(chemo)therapy - Level 1:
    54/ 59,4 Gy
  • De-escalation radio(chemo)therapy - Level 2:
    48,8/ 55 Gy
  • Standard radio(chemotherapy):
    60/ 66 Gy

Quelle: ClinicalTrials.gov


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