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Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE

Best Of Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma

Rekrutierend

NCT-Nummer:
NCT02984410

Studienbeginn:
November 2017

Letztes Update:
17.11.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Oropharyngeal Neoplasms, Carcinoma, Squamous Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC

Collaborator:
Swiss Group for Clinical Cancer Research

Studienleiter

Christian Simon
Study Chair
Centre Hospitalier Universitaire Vaudois

Kontakt

Studienlocations (3 von 26)

Universitaetsklinikum Jena
Jena
(Thüringen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Koeln
Koeln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Staedtisches Klinikum Leipzig - Klinikum St Georg
Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Leipzig
Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Tuebingen- Crona Kliniken
Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Cliniques Universitaires Saint-Luc
Brussels
BelgiumRekrutierend» Google-Maps
Institut Jules Bordet-Hopital Universitaire ULB
Brussels
BelgiumRekrutierend» Google-Maps
Hopitaux Universitaires de Strasbourg - Hautepierre
Strasbourg
FranceRekrutierend» Google-Maps
Institut de Cancérologie de Lorraine
Vandoeuvre-Les-Nancy
FranceRekrutierend» Google-Maps
Universita Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia
Brescia
ItalyRekrutierend» Google-Maps
Centre Hospitalier Universitaire Vaudois - Lausanne
Lausanne
SwitzerlandRekrutierend» Google-Maps
UniversitaetsSpital Zurich - Klinik fur Ohren, Hals und Gesichtschirurgie
Zürich
SwitzerlandRekrutierend» Google-Maps
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
Bristol
United KingdomRekrutierend» Google-Maps
Cambridge University Hospital NHS - Addenbrookes Hospital
Cambridge
United KingdomRekrutierend» Google-Maps
Cardiff and Vale University Health Board - University Hospital of Wales
Cardiff
United KingdomRekrutierend» Google-Maps
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
Cottingham
United KingdomRekrutierend» Google-Maps
Aintree University Hospital NHS Trust
Liverpool
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Eligible patients will be randomized 1 to 1 to radiotherapy (Arm 1) or surgery (Arm 2).

ARM 1: Radiotherapy

Intensity modulated radiation therapy (IMRT) with Simultaneous integrated boost (SIB) will be

applied to all patients in this arm. PTV prescription to tumor and high risk areas will be

delivered daily for 5 days per week to a total dose of 66-70Gy in 2 Gy/fraction over 6 weeks,

elective/prophylactic mucosal and nodal areas will receive a total dose of 54.25- 54.45 Gy in

33-35 fractions of 1.55-1.65 Gy over 6 weeks.

ARM 2: Surgery

Trans-oral surgery (any trans-oral approach such as trans-oral laser microsurgery

conventional trans-oral surgery or trans-oral robotic surgery) will be applied to all

patients in this arm.

A surgical margin is defined to be clear (R0), if found to be >/=3mm in the final specimen

(except deep margin for tonsillar resection, that is either R1 or R0), is defined to be

close, if 1-<3mm, and considered to be involved (R1), if <1mm in the final specimen. Clearly

defined marginal biopsies are required for each TOS-technique. Trans-oral re-resections are

required in case of R1 or close-margin to convert the patient to an R0-status.Postoperative

RT or chemo-RT will be given within 5-6 weeks of surgery in case of positive.

Ein-/Ausschlusskriterien

Main Inclusion Criteria:

- OPSCC in one of the following sub-sites: base of tongue, lateral pharyngeal wall,

tonsil, glosso-tonsillar sulcus, vallecula or SGSCC in one or more of the following

sub-sites: epiglottis, aryepiglottic fold, false cord or HPSCC in one or more of the

following subsites: Lateral and medial wall of piriform sinus (sub-sites are defined

as lateral (lateral pharyngeal wall, tonsil, glosso-tonsillar sulcus, lateral piriform

sinus) vs. central lesions (base of tongue, vallecula, all supraglottic sites, medial

wall of piriform sinus))

- TNM stage I-III (7th AJCC classification): T1 or T2, N0 or T1 or T2, N1 with one

single neck node ≤ 3cm without radiographic signs of extracapsular extension (ECE),

M0;

- TNM stage I for HPSCC: T1, N0, M0. ;Within 2 weeks before randomization, assessment by

a Multi-Disciplinary Team (MDT) composed of at least a head and neck/ENT surgeon,

oncologist, radiologist, radiotherapist, and pathologist of the treatment naïve

patient and suitable for either TOS or IMRT based on:

- CT with contrast and/or MRI done within 4 weeks prior to randomization

- Pan-endoscopy with assessment of trans-oral exposure for resection.

- Age 18 and older; Age 18 to 70 for SGSCC

- ECOG Performance status ≤ 2;

- Availability of biological material for HPV/p16 testing for OPSCCs

- Study information and Informed consent discussed by the surgeon and radio-oncologist

and signed by the patient.

- Within 2 weeks prior randomization:

- Baseline MDADI score available;

- Adequate bone marrow function as demonstrated by neutrophils count > 1,5 109 /L ,

platelets count > 75 109 /L, WBC≥ 3.0 109 /L;

- Prothrombin time (PT) with an international normalized ratio (INR) ≤ 1.2

- Partial thromboplastin time (PTT) ≤ 1.2 times ULN

- Normal 12-lead ECG;

- Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy

test no more than 72 hours prior to randomization.

- Patients of childbearing / reproductive potential should agree to use adequate birth

control measures for 3 months, especially if they will undergo any radiotherapy

treatment at any time during the study. A highly effective method of birth control is

defined as those which result in low failure rate (i.e. less than 1% per year) when

used consistently and correctly.

Main Exclusion Criteria:

- Patient with bilateral tumors

- Any previous anti-cancer therapy for HNSCC (chemo or radiotherapy or molecular

targeted therapy);

- Any active malignancy (other than non-melanoma skin cancer or localized cervical

cancer or localized and presumed cured prostatic cancer) within the last 5 years with

ongoing systemic treatment

- Cancer in contact with the internal and/or external carotid artery

- Extension of OPSCC across the midline of the base-of-tongue

- Arytenoid involvement in case of SGSCC

- Involvement of >50% of the soft palate by cancer, requiring a reconstruction with a

free flap or any other involvement of the soft palate requiring a reconstruction with

a free flap judged by the surgeon

- Cancer originating from the soft palate or posterior pharyngeal wall

- Pre-existing dysphagia not related to the oropharyngeal cancer or diagnostic biopsies

- Any psychological, cognitive, familial, sociological or geographical condition

potentially hampering compliance with the study protocol, completion of patient

reported measures and follow-up schedule; those conditions should be discussed with

the patient before registration in the trial

Studien-Rationale

Primary outcome:

1. Change in the MD Anderson Dysphagia Inventory (MDADI) score (Time Frame - at 4.5, 6, 9 and 12 months after randomization)

Studien-Arme

  • Other: Intensity-Modulated Radiation Therapy (IMRT)
    PTV prescription to tumor and high risk areas will be delivered daily for 5 days per week to a total dose of 66-70Gy in 2 Gy/fraction over 6 weeks, elective/prophylactic mucosal and nodal areas will receive a total dose of 54.25- 54.45 Gy in 33-35 fractions of 1.55-1.65 Gy over 6 weeks.
  • Other: Trans Oral Surgery (TOS)
    The following surgical techniques are allowed: Transoral Robotic Surgery (TORS) Transoral Microsurgery (TLM) Conventional trans-oral Surgery (CTOS)

Geprüfte Regime

  • Intensity-Modulated Radiation Therapy (IMRT):
    IMRT (Simultaneous Integrated Boost (SIB) and accelerated regimen) with selective neck node dissection
  • Trans Oral Surgery (TOS):
    TOS (Trans Oral Laser Microsurgery (TLM), Trans Oral Robotic Surgery (TORS), conventional) with selective neck node dissection

Quelle: ClinicalTrials.gov


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