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IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas (TORPHYNX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04224389
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:
Compare patients' feelings in terms of swallowing ability assessed by the overall score of MD Anderson Dysphagia Inventory (MDADI) 2 years after starting treatment between patients who have been treated with IMRT and those who were treated by transoral surgery for a squamous cell carcinoma of the early stage oropharynx.

Condition or disease Intervention/treatment
Squamous Cell Carcinoma Procedure: transoral resection Radiation: IMRT

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Non-randomized Comparative Study Between IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas of Early Local Stage of Oropharynx
Actual Study Start Date : June 22, 2018
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2026

Group/Cohort Intervention/treatment
Radiotherapy
IMRT on the primitive site and the lymph nodes. +/- Concomitant chemotherapy at the discretion of the meeting multidisciplinary
Radiation: IMRT
Intensity modulation radiotherapy (RCMI or IMRT) will be performed using techniques static or rotational (arctherapy, tomotherapy). Restraint is recommended with thermoformed mask

Surgery
transoral resection of the primary tumor, with cervical lymph node dissection. Radiotherapy complementary according to the histological criteria of severity
Procedure: transoral resection
The technique of transoral surgery will be left to the choice of the surgeon according to the equipment and the experience of the team and will be gathered. The options are: transoral surgery robot-assisted, endoscopic laser transoral surgery, transoral laser surgery classical instruments. The exact description of the resected area will be collected. of the cross-sections will be made for extemporaneous analysis if necessary in lateral margins and deep until complete excision.




Primary Outcome Measures :
  1. MD Anderson Dysphagia Inventory (MDADI) global score [ Time Frame: 2 years after inclusion ]
    Score goes from 20 to 100. A higher score means a better ability to swallow



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients who have been treated with IMRT and those who were treated by transoral surgery for a carcinoma squamous cell of the early stage oropharynx
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. ECOG performance status 0-2
  3. Histologically confirmed squamous cell carcinoma
  4. Primitive localization of the oropharynx on the tonsil compartment or the tongue base
  5. p16 or HPV status available
  6. TNM classification AJCC7th T1 or T2
  7. TNM classification AJCC7th N0 or N1
  8. Patient and tumor that can be treated by radiotherapy or by transoral surgery
  9. Patient who has not objected to participate after being informed about the study. The patient must be able and willing to cooperate in follow-up and study visits

Exclusion Criteria:

  1. Severe medical comorbidity or other contraindication to radiotherapy or surgery
  2. Primary tumor or unresectable lymphadenopathy
  3. Metastatic disease
  4. History of squamous cell carcinoma of the head and neck within 5 years
  5. History of radiation therapy to the head and neck
  6. Inability to undergo or complete radiation therapy follow-up consultations
  7. History of cancer except free of any disease for at least 5 years, with the exception of non-melanoma skin cancers
  8. Inability to complete questionnaires
  9. Pregnant or lactating woman
  10. Patient under tutorship or curatorship, deprived of liberty or unable to do so to express consent

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): NCT04224389


Contacts
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Contact: Philippe Gorphe, MD 0142114211 ext +33 philippe.gorphe@gustaveroussy.fr
Contact: Thibaud Motreff 0142114211 ext +33 thibaud.motreff@gustaveroussy.fr

Locations
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France
Gustave Roussy Recruiting
Villejuif, Val De Marne, France, 94800
Contact: Philippe Gorphe, MD    0142114211 ext +33    philippe.gorphe@gustaveroussy.fr   
Contact: Thibaud Motreff    0142114211 ext +33    thibaud.motreff@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris

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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT04224389    
Other Study ID Numbers: 2017-A02253-50
2017/2617 ( Other Identifier: CSET number )
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell