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

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ClinicalTrials.gov Identifier: NCT02984410
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : August 3, 2020
Sponsor:
Collaborator:
Swiss Group for Clinical Cancer Research
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

Oropharyngeal Squamous Cell Carcinoma (OPSCC) arises in the soft palate, tonsils, base of tongue, pharyngeal wall, and the vallecula. Most of the patients with early stage OPSCC are usually cured. Treatment of early stage OPSCC can be successfully achieved with primary surgery including neck dissection, as indicated, or with definitive radiotherapy. The current standard treatment for OPSCC is therefore based on either surgery and/or radiotherapy, both associated with comparable, high tumor control rates but with different side effects profiles and technical constraints.

In order to decrease the potential morbidity of surgery, transoral approaches have been developed within the last decades, including transoral robotic surgery (TORS), transoral laser microsurgery (TLM) or conventional transoral techniques. On the other hand, patients with head and neck cancer treated with IMRT experienced significant improvements in cause specific survival (CSS) compared with patients treated with non-IMRT techniques thus suggesting that IMRT may be beneficial in terms of patient's outcomes and toxicity profile. It is as yet unclear however, which one of the new techniques is superior to the other in terms of function preservation. Given that the functional outcome of most importance is swallowing function, the preservation of swallowing is thus of major importance.

The main objective of the study is to assess and compare the patient-reported swallowing function over the first year after randomization to either IMRT or TOS among patients with early stage OPSCC, SGSCC, and HPSCC.


Condition or disease Intervention/treatment Phase
Oropharyngeal Cancer Supraglottic Squamous Cell Carcinoma Hypopharyngeal Squamous Cell Carcinoma Radiation: Intensity-Modulated Radiation Therapy (IMRT) Procedure: Trans Oral Surgery (TOS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study Assessing the "Best of" Radiotherapy Compared to the "Best of" Surgery (Trans-oral Surgery (TOS)) in Patients With T1-T2, N0-N1 Oropharyngeal, Supraglottic Carcinoma and With T1, N0 Hypopharyngeal Carcinoma
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Radiation: Intensity-Modulated Radiation Therapy (IMRT)
IMRT (Simultaneous Integrated Boost (SIB) and accelerated regimen) with selective neck node dissection

Trans Oral Surgery (TOS)

The following surgical techniques are allowed:

Transoral Robotic Surgery (TORS) Transoral Microsurgery (TLM) Conventional trans-oral Surgery (CTOS)

Procedure: Trans Oral Surgery (TOS)
TOS (Trans Oral Laser Microsurgery (TLM), Trans Oral Robotic Surgery (TORS), conventional) with selective neck node dissection




Primary Outcome Measures :
  1. Change in the MD Anderson Dysphagia Inventory (MDADI) score [ Time Frame: at 4.5, 6, 9 and 12 months after randomization ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984410


Contacts
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Contact: EORTC HQ +32 2 774 16 11 eortc@eortc.org

Locations
Show Show 22 study locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Swiss Group for Clinical Cancer Research
Investigators
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Study Chair: Christian Simon Centre Hospitalier Universitaire Vaudois
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT02984410    
Other Study ID Numbers: EORTC-1420-HNCG-ROG
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
T1-T2, N0-N1 oropharyngeal carcinoma, supraglottic carcinoma, T1, N0 hypopharyngeal carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases