Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06798922

Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers

Led by Centre Francois Baclesse · Updated on 2026-03-03

348

Participants Needed

25

Research Sites

469 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Patients with oral cavity cancer treated by reconstructive surgery with a flap. Patients will be treated in the study for : * Experimental arm: Post-operative radiotherapy with flap sparing * Control arm: Standard post-operative radiotherapy without flap sparing (current practice) Radiotherapy by IMRT using photons or proton therapy (IMPT)

CONDITIONS

Official Title

Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 18 years or older
  • Performance Status 0-2
  • Diagnosis of oral cavity cancer (soft tissue or soft tissue-bone flap) treated by reconstructive surgery with a flap; or oropharynx cancer with flap extending into the oral cavity
  • Quality of surgical resection with margins greater than 1 mm
  • Candidate for post-operative radiotherapy using IMRT or proton therapy
  • Concomitant chemotherapy allowed
  • Signed written informed consent before trial procedures
  • Affiliated to the social security system
Not Eligible

You will not qualify if you...

  • Local flap of small size limiting IMRT modulation potential
  • History of radiotherapy to the head and neck area
  • Presence of metastatic disease
  • History of other malignancy within the last 3 years (except treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
  • Participation in another clinical study that may interfere with this study
  • Pregnant or lactating women
  • Assessed by investigator as unable or unwilling to comply with protocol requirements
  • Patient deprived of freedom or under guardianship

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 25 locations

1

Chu Amiens

Amiens, France

Not Yet Recruiting

2

Institut de Cancérologie de l'Ouest

Angers, France

Not Yet Recruiting

3

Centre François Baclesse

Caen, France

Actively Recruiting

4

CHU CAEN

Caen, France

Not Yet Recruiting

5

Centre Jean Perrin

Clermont-Ferrand, France

Not Yet Recruiting

6

CHIC

Créteil, France

Not Yet Recruiting

7

Centre Georges-François Leclerc

Dijon, France

Not Yet Recruiting

8

Centre Guillaume le Conquérant

Le Havre, France

Not Yet Recruiting

9

Centre Hospitalier

Libourne, France

Not Yet Recruiting

10

Centre Oscar Lambret

Lille, France

Not Yet Recruiting

11

Centre Léon Bérard

Lyon, France

Not Yet Recruiting

12

APHM Marseille

Marseille, France

Not Yet Recruiting

13

Institut Régional du Cancer Val D'aurelle

Montpellier, France

Not Yet Recruiting

14

Institut de Cancérologie de Lorraine

Nancy, France

Not Yet Recruiting

15

Centre Antoine Lacassagne

Nice, France

Not Yet Recruiting

16

APHP La Pitié

Paris, France

Not Yet Recruiting

17

Chu Poitiers

Poitiers, France

Not Yet Recruiting

18

Institut Jean Godinot

Reims, France

Not Yet Recruiting

19

Centre Eugène Marquis

Rennes, France

Not Yet Recruiting

20

Centre Henri Becquerel

Rouen, France

Not Yet Recruiting

21

Chu Rouen

Rouen, France

Not Yet Recruiting

22

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

Not Yet Recruiting

23

IUCT

Toulouse, France

Not Yet Recruiting

24

Chu Tours

Tours, France

Not Yet Recruiting

25

Institut Gustave Roussy

Villejuif, France

Not Yet Recruiting

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Research Team

J

Juliette THARIAT, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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