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STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03 (STEREOPOSTOP)

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: NCT03401840
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : May 27, 2020
Sponsor:
Collaborator:
GORTEC
Information provided by (Responsible Party):
Centre Jean Perrin

Brief Summary:
The main objective of this national, open-label, non-randomized phase II trial is to evaluate severe late toxicity of postoperative hypofractionated stereotactic radiotherapy (SBRT) in the treatment of early stage oropharyngeal and oral cavity cancer with high risk margins.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Radiation: postoperative hypofractionated stereotactic radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Prospective Phase II Study of Postoperative Hypofractionated Stereotactic Body Radiotherapy (SBRT) in the Treatment of Early Stage Oropharyngeal and Oral Cavity Cancers With High Risk Margins.
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: postoperative SBRT
SBRT consists of a total dose of 36 Gy in 6 fractions over 11-13 days
Radiation: postoperative hypofractionated stereotactic radiotherapy
total dose of 36Gy in 6 fractions over 11-13 days




Primary Outcome Measures :
  1. severe late toxicity [ Time Frame: from 3 months to 2 years following the end of radiotherapy ]
    2-year toxicity of grade ≥ 3 related to SBRT according to CTCAE V4.03 classification.


Secondary Outcome Measures :
  1. Local control [ Time Frame: 2 years following the end of radiotherapy ]
    2-year local control rate - Any local recurrence (T) will be considered as an event.

  2. Locoregional control [ Time Frame: 2 years following the end of radiotherapy ]
    2-year locoregional control rate - Any local (T) or lymph node (N) recurrence will be considered as an event

  3. Acute toxicity [ Time Frame: from the first fraction to 3 months after the end of radiotherapy ]
    ≤ 3-month toxicity of grade ≥ 3 related to SBRT according to CTCAE V4.03 classification.

  4. disease free survival (DFS) [ Time Frame: 2 years following the end of radiotherapy ]
    2-year DFS rate - DFS is time from randomization to the date of first occurrence of any locoregional recurrence, distant progression or death from any cause.

  5. Overall survival (OS) [ Time Frame: 2 years following the end of radiotherapy ]
    2-year OS rate - OS is defined as time from randomization to death from any cause

  6. Quality of life (global evaluation) [ Time Frame: at baseline, 1 month, 1 year and 2 years post radiotherapy ]
    evaluated by EORTC QLQC30

  7. Quality of life (specific evaluation for Head and Neck Cancer) [ Time Frame: at baseline, 1 month, 1 year and 2 years post radiotherapy ]
    evaluated by EORTC QLQ HN35 module

  8. Nutritional impact [ Time Frame: during 2 years following the end of radiotherapy ]
    evaluated by weight loss

  9. Nutritional support [ Time Frame: during 2 years following the end of radiotherapy ]
    evaluated by the use of feeding tubes

  10. Predictive factors of toxicity [ Time Frame: 2 years following the end of radiotherapy ]
    clinical and/or dosimetric factors associated to late severe toxicities (grade ≥ 3 related to SBRT according to CTCAE V4.03 classification).



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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

Inclusion Criteria:

  • Operated squamous cell carcinoma of oral cavity (lips excepted) or oropharynx
  • pT1 or pT2 ((UICC 7th edition 2009)
  • Indication of postoperative tumor site irradiation (retained in multidisciplinary tumor board) with at least one of the following criteria :

    • positive R1 margin (re-resection not proposed)
    • close margin < 5 mm (re-resection not proposed)
    • Margin estimated at risk, with uncertain pathological margin (re-resection not proposed)
  • N0 after surgical management of the neck (neck dissection or sentinel lymph node biopsy) or pN1 without extracapsular extension (carcinological neck dissection)
  • Age ≥ 18 years
  • ECOG status ≤ 2
  • Written signed informed consent before any specific procedure of the protocol
  • Affiliation to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

  • Other histology than squamous cell carcinoma
  • pT3 or pT4
  • pT2>3cm and R1 with concurrent chemoradiotherapy decided in multidisciplinary tumor board
  • Lymphovascular invasion justifying neck irradiation
  • Neck irradiation decided in multidisciplinary tumor board
  • Lack of at least one of the following elements :

    • pre-operative medical imaging (CT scan or MRI)
    • endoscopy report
    • surgery report
    • pathological report
  • Prior radiotherapy to the head and neck area
  • Distant metastasis
  • Pregnant or nursing (lactating) woman
  • women or men of childbearing age not taking adequate contraceptive measure
  • participation in another investigational study within 4 weeks prior to inclusion
  • History of other malignancy within 5 years prior enrollment except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
  • Persons deprived of their liberty, under guardianship or curatorship, or unable to follow the trial for geographical, social or psychological reasons

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): NCT03401840


Contacts
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Contact: Julian BIAU, Dr 33473278089 julian.biau@clermont.unicancer.fr

Locations
Show Show 24 study locations
Sponsors and Collaborators
Centre Jean Perrin
GORTEC
Investigators
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Principal Investigator: Julian BIAU Centre Jean Perrin
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT03401840    
Other Study ID Numbers: 2017-A02058-45
PHRC-K16-164 ( Other Grant/Funding Number: Directorate of Health Care Supply (DGOS), National Cancer Institute (INCa), France )
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Centre Jean Perrin:
Head and neck cancers
Radiation oncology
Stereotactic radiotherapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms