De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06030440

Studienbeginn:
Januar 2024

Letztes Update:
11.04.2024

Wirkstoff:
-

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Erlangen-Nürnberg Medical School

Collaborator:
-

Studienleiter

Sarina Müller, PD
Study Director
Universitätsklinikum Erlangen, HNO

Rainer Fietkau, Prof
Principal Investigator
Universitätsklinikum Erlangen, Radiation Oncology

Kontakt

Marlen Haderlein, PD
Kontakt:
Phone: +49913185
Phone (ext.): 33968
E-Mail: marlen.haderlein@uk-erlangen.de» Kontaktdaten anzeigen

Studiensekretariat
Kontakt:
Phone: +49913185
Phone (ext.): 33968
E-Mail: studiensekretariat.ST@uk-erlangen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Universitätsklinikum Erlangen, Strahlenklinik
91054 Erlangen
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Marlen Haderlein, PD
Phone: +49913185
Phone (ext.): 33968
E-Mail: marlen.haderlein@uk-erlangen.de

Rainer Fietkau, Prof
Phone: +49913185
Phone (ext.): 33968
E-Mail: rainer.fietkau@uk-erlangen.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

This study aims to determine whether it is possible to achieve an individual target volume

concept that eliminates elective irradiation of uninvolved lymph drainage areas while

maintaining clearly defined surgical standards and using modern imaging and radiation

techniques. The aim of this study is to achieve reduced late toxicity without compromising

locoregional control.

Patients will be randomized to: either RT to primary tumor region, regions with lymph node

metastases and elective nodal irradiation (control arm) or RT to primary tumor region and

regions with lymph node metastases without elective nodal irradiation (investigational arm)

A two-stage design was chosen for this purpose.

Phase II:

A randomized phase II study whose primary endpoint is the 1-year percutaneous endoscopic

gastrostomy (PEG) tube dependence rate will be performed first.

Phase III:

If the primary endpoint of the phase II study is met and the interim analysis shows no

increase in the locoregional recurrence rate in the study/investigational arm, the study will

be continued as a phase III study whose primary endpoint is the locoregional control rate.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Histologically proven squamous cell carcinoma of the oral cavity/larynx/oro-or

hypopharynx (except glottis cancer (pT1/2pN0))

2. Surgery of primary tumor and neck dissection performed according to predefined

surgical standard

3. Indication for postoperative radio(chemo)therapy

4. No lymph node metastases > 6cm

5. Lymph node metastases in not more than 3 lymph node level

6. No distant metastases (cM0)

7. Age ≥ 18 years, no upper age limit

8. Eastern Cooperative Oncology Group (ECOG) ≤ 2

9. Patients who understood protocol contents and are able to behave according to protocol

10. Signed study-specific consent form prior to therapy

11. Start of radiotherapy at least 6 weeks after last tumor-specific surgery (e.g.

resection primary tumor, neck dissection, excluded are surgeries according to wound

healing complications)

Exclusion Criteria:

1. macroscopic incomplete resection R2

2. Distant metastases (cM1)

3. Radiologically or histologically proven early recurrence after surgery (time frame

from surgery to start of radio(chemo)therapy)

4. Lymph node metastases in > 3 lymph node level

5. pregnant or lactating/nursing women

6. fertile patients that are not willing to use highly effective methods of contraception

(per institutional standards) during treatment

7. Any condition potentially hampering compliance with the study protocol and follow-up

schedule

8. On-treatment participation on other clinical therapeutic trials

9. Prior tumor-specific therapy any other than surgery (like prior radiotherapy in the

head and neck region, prior chemo- or immunotherapy (neoadjuvant/induction))

10. Patients who have contraindication for MRI and CT with contrast agent (both)

11. Prior (> 2 months before beginning of radio(chemo)therapy) neck dissection or surgery

in the head and neck area affecting lymph drainage

12. History of another primary malignancy except for malignancy treated with curative

intent and with no known active disease ≥5 years before diagnosis of head and neck

cancer, adequately treated non-melanoma skin cancer or lentigo maligna without

evidence of disease, adequately treated carcinoma in situ without evidence of disease

Studien-Rationale

Primary outcome:

1. Phase II: 1-year PEG feeding tube dependence rate (Time Frame - PEG-dependent 1 year after radiotherapy):
observe change of PEG-dependence due to different target volumes

2. Phase III: Time to local relapse (Time Frame - From the date of randomization until the date of observation of local relapse or the date of last observation if no LR occurred, whichever came first (assessed up to 26 months)):
difference between the date of randomization and the date of observation of local relapse (LR), or the date of last observation if no LR occurred (censored observation)

Secondary outcome:

1. Disease-free survival (Time Frame - up to 26 months):
Disease-free survival

2. Distant-metastasis-free survival (Time Frame - through study completion, an average of 26 months):
Distant-metastasis-free survival

3. Overall survival (OS) (Time Frame - up to 26 months):
Overall survival (OS)

4. Cause of death (tumor-related, not tumor-related) (Time Frame - through study completion, an average of 26 months):
Cause of death (tumor-related, not tumor-related)

5. Acute toxicity according to Common Terminology Criteria (CTC) version 5.0 (Time Frame - up to 2 months):
Acute toxicity according to CTC version 5.0

6. Late toxicity according to CTC version 5.0 (Time Frame - up to 24 months):
Late toxicity according to CTC version 5.0

Studien-Arme

Active Comparator: Control Arm
postoperative radiotherapy of the head and neck region according to current standard including elective nodal irradiation
Experimental: Investigational Arm
postoperative radiotherapy of the head and neck region without elective nodal irradiation

Geprüfte Regime

Eliminating RT to the elective neck:
Reduction of radiation volume by eliminating radiotherapy to the elective neck
RT standard of care:
postoperative radiotherapy of the head and neck region according to current standard including elective nodal irradiation

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!