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Completed

NCT Number: NCT03401840

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

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.

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Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Sainte Catherine, Avignon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

postoperative hypofractionated stereotactic radiotherapy

Radiation

total dose of 36Gy in 6 fractions over 11-13 days

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Collaborators

  • GORTEC

Registry information

Official study 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.

Acronym: STEREOPOSTOP

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2018
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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