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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

Tracking Information
First Submitted Date January 8, 2020
First Posted Date January 13, 2020
Last Update Posted Date February 17, 2020
Actual Study Start Date June 22, 2018
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 14, 2020)
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
Original Primary Outcome Measures
 (submitted: January 8, 2020)
MD Anderson Dysphagia Inventory (MDADI) global score [ Time Frame: 2 years after inclusion ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Squamous Cell Carcinoma
Intervention
  • 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.
  • Radiation: IMRT
    Intensity modulation radiotherapy (RCMI or IMRT) will be performed using techniques static or rotational (arctherapy, tomotherapy). Restraint is recommended with thermoformed mask
Study Groups/Cohorts
  • Radiotherapy
    IMRT on the primitive site and the lymph nodes. +/- Concomitant chemotherapy at the discretion of the meeting multidisciplinary
    Intervention: Radiation: IMRT
  • Surgery
    transoral resection of the primary tumor, with cervical lymph node dissection. Radiotherapy complementary according to the histological criteria of severity
    Intervention: Procedure: transoral resection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 8, 2020)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2026
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Philippe Gorphe, MD 0142114211 ext +33 philippe.gorphe@gustaveroussy.fr
Contact: Thibaud Motreff 0142114211 ext +33 thibaud.motreff@gustaveroussy.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04224389
Other Study ID Numbers 2017-A02253-50
2017/2617 ( Other Identifier: CSET number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Gustave Roussy, Cancer Campus, Grand Paris
Study Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Collaborators Not Provided
Investigators Not Provided
PRS Account Gustave Roussy, Cancer Campus, Grand Paris
Verification Date February 2020