Status:

RECRUITING

Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers

Lead Sponsor:

Centre Francois Baclesse

Conditions:

Oral Cavity Carcinoma

Flap

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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 * Contro...

Detailed Description

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 * Contro...

Eligibility Criteria

Inclusion Criteria:

  • Patient aged 18 years or older
  • Performance Status 0-2
  • Patient with oral cavity cancer (soft tissue or soft tissue-bone flap), treated by reconstructive surgery with a flap. Oropharynx cancer whose flap extends significantly into the oral cavity may be included in the study
  • Quality of resection with margins > 1 mm
  • Patient candidate to post-operative radiotherapy (Intensity-Modulated Radiation Therapy (IMRT) or proton therapy)
  • Concomitant chemotherapy is allowed (stratification parameter)
  • Patient must have signed a written informed consent form prior to any trial specific procedures
  • Patient affiliated to the social security system

Exclusion Criteria:

  • Local flap (small size limiting IMRT modulation potential)
  • History of radiotherapy of head and neck area
  • Metastatic disease
  • History of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
  • Simultaneous participation in another clinical study may compromise the conduct of this study.
  • Pregnant or lactating women
  • Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
  • Patient deprived of freedom or under guardianship

Key Trial Info

Start Date :

March 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2034

Estimated Enrollment :

348 Patients enrolled

Trial Details

Trial ID

NCT06798922

Start Date

March 1 2025

End Date

March 1 2034

Last Update

March 3 2026

Active Locations (25)

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Page 1 of 7 (25 locations)

1

Chu Amiens

Amiens, France

2

Institut de Cancérologie de l'Ouest

Angers, France

3

Centre François Baclesse

Caen, France

4

CHU CAEN

Caen, France