NCT02469922

Brief Summary

Open multicentric study assessing predictive value of 18-FDG PET (SUV max) at 20 Gy during radio-chemotherapy, on the loco-regional control after 2 years

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2014

Completed
12 months until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2020

Enrollment Period

6.7 years

First QC Date

June 25, 2014

Last Update Submit

July 26, 2021

Conditions

Malignant Neoplasm of Head and NeckLocally Advanced Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Locoregional relapse

    2 years

Secondary Outcomes (1)

  • Comparison of TEP scan values (Standardized Update Value max, Metabolic Tumor Volume)

    pretreatment, 15 days, 29 days, 3 months post treatment

Study Arms (1)

Positron emission tomography

EXPERIMENTAL

Two additional PET Scan will be performed at 2 and 4 weeks for the first 30 patients. Then for the other patients only one additional PET-Scan will be performed

Device: Positron emission tomographyRadiation: radiochemotherapy

Interventions

Positron emission tomographyDEVICE
Positron emission tomography
radiochemotherapyRADIATION

Every patients will be treated with radiochemotherapy as a standard of care

Positron emission tomography

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years and ≤ 75 years
  • invasive epidermoid carcinoma of head and neck (excluding nasopharyngeal), confirmed by histology
  • locally advanced disease (non-metastatic stages AJCC III-IV). AJCC = American Joint Committee on Cancer
  • performance status ECOG ≤ 2. ECOG = Eastern Cooperative Oncology Group
  • no history of irradiation of the head and neck
  • start of radiotherapy within 8 weeks after the pretreatment PET Scan
  • no surgery other than biopsy
  • pregnancy test: negative for women of childbearing potential
  • reliable contraception for a childbearing couple, men and woman must have a reliable contraception during treatment
  • signed informed consent form
  • patient with national health insurance

You may not qualify if:

  • prior radiotherapy or chemotherapy
  • history of other cancer except: cutaneous non-melanoma tumor and cervix in situ carcinoma
  • unstable conditions (cardiovascular, renal, pulmonary) or systemic (lupus erythematosus, scleroderma)
  • pregnant patient or patient with breastfeeding
  • patient unable to give his consent
  • patient under administrative supervision
  • patient who participates to another clinical trial on experimental drug
  • regular follow-up impossible for various reasons (familial, economical, social, ...)
  • diabetes
  • accelerated radiotherapy protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Brest

Brest, France

Location

Centre jean Bernard - Rue Victor Hugo

Le Mans, 72015, France

Location

Hôpital du Scorff

Lorient, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre d'Oncologie St Vincent - Boulevard de la Boutière

Saint-Grégoire, 35460, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Positron-Emission TomographyChemoradiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, RadioisotopeCombined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Study Officials

  • Castelli Joël, Doctor

    Centre de Lutte Contre le Cancer Centre Eugène Marquis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2014

First Posted

June 12, 2015

Study Start

June 1, 2014

Primary Completion

January 29, 2021

Study Completion

January 29, 2021

Last Updated

July 27, 2021

Record last verified: 2020-07

Locations

FR(5)