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Upper Digestive Tract CancerATIMNCT00925509

Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts

A study testing Therapeutic assessment -Radio-surgical guidance. in people with Upper Digestive Tract Cancer, run by Centre Leon Berard at 4 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Aero digestive Cancer patients treated by external head and neck radiotherapy and/or by curie-therapy and/or mandible reconstruction by microanastomosed fibula flaps. The purpose of the study is to Investigate the accuracy of implants insertion in the anteroposterior way, using radiosurgical guidance. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Upper Digestive Tract Cancer
What is being tested?
Therapeutic assessment -Radio-surgical guidance.
Type of treatment
Surgery or procedure
How many people
53 participants
Where
4 sitesFrance
Study dates
Sep 2007to Dec 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age over 18
  • Performance status over 70
  • Histological evidence of upper digestive tract cancer
  • History of cranial / facial radiotherapy or brachytherapy and/or microvascular fibula transfer.
  • Bone volume sufficient to support an implant.
  • Mandatory affiliation with a social security system
  • Written, voluntary, informed consent

Who cannot join

  • Patient with evolutive malignant disease
  • Contraindication to general anesthesia
  • Concurrent disease contra-indicating implant surgery (risk of infectious endocarditis, uncontrolled diabetes, HIV, evolutive neoplasia…)
  • Patient enrolled in another clinical trial including chemotherapy
  • Pregnant or lactating woman
  • Anticipation of an impossible follow-up
  • Patient deprived of freedom

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • CHU Hôtel-Dieu Service d'Odontologie

    Clermont-Ferrand, 63 000

  • Centre Léon Bérard Service de Chirurgie-Stomatologie

    Lyon, Cedex 08, 69373

  • Hospices Civils de Lyon Service de Consultations et Traitements Dentaires

    Lyon, 69007

  • Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale

    Pierre-Bénite, 69495

Other trials in France

About this study

Aero digestive Cancer patients treated by external head and neck radiotherapy and/or by curie-therapy and/or mandible reconstruction by microanastomosed fibula flaps. The purpose of the study is to Investigate the accuracy of implants insertion in the anteroposterior way, using radiosurgical guidance.

Read the detailed description
  • Investigate the accuracy of inserting implants in the vertical way and in angulation, on irradiated native mandible or on microanastomosed fibula flaps
  • Investigate the accuracy of inserting implants in the anteroposterior way, in the vertical way and in angulation for all the involved patients (meaning on irradiated native mandible or on microanastomosed fibula flaps)
  • Investigate the delay of mucous healing
  • Estimate the prosthetic function
  • Evaluate the osteonecrosis rate after radiation with traumatic etiology due to implantation
  • Estimate the implant rate due to minimally invasive flaps
  • Estimate the implant rate due to pure trans mucosa way
  • Estimate the post surgical therapeutic success after 1 year
Being tested
Therapeutic assessment -Radio-surgical guidance.
Keywords
upper digestive tract cancer, implants, implants insertion, radio-surgical guidance, accuracy of implants insertion, cranial/facial radiotherapy or brachytherapy and/or microvascular fibula transfer., Bone volume sufficient to support an implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic assessment -Radio-surgical guidance.Procedure or surgery

    The first steps of the procedure include the production of a radiosurgical guide and the preparation of a mask in order to allow precise, non invasive repositioning of the guide.

    Secondarily, the patient undergoes a CT-scan with the mask on and the radiosurgical guide in place. This provisional scan is used for preimplantation evaluation and drilling of the guide hole.

    Under general anaesthesia, the mask is placed on the patient and the guide is fixed to the mask. A hole is drilled with a burr in the mandible through the hole in the guide. Implants are placed and the guide and mask are removed.

    A second, post-implantation CT-scan is planned 3 months after implantation. Comparison of pre- and post-implantation CT-scans allows to evaluate the precision of the placement.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of implants insertion, radio-surgical guidance.

    Measured: 8 months after inclusion

Secondary outcomes (6)

  1. Accuracy of inserting implants

    Measured: 16 months after inclusion

  2. Delay of mucous healing

    Measured: 16 months after inclusion

  3. Estimation of the prosthetic function

    Measured: 16 months after inclusion

  4. Osteonecrosis rate after radiation with traumatic etiology due to implantation

    Measured: 16 months after inclusion

  5. Implant rate

    Measured: 16 months after inclusion

  6. Post surgical therapeutic success after 1 year

    Measured: after 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2009 (estimated)
  2. Study startSep 2007
  3. Primary completionDec 2011 (estimated)
  4. Study completionDec 2011 (estimated)

Why it stopped: Insufficient recruitment, too much selective inclusion criteria, feasibility problems

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00925509
Sponsor's protocol ID
ET2006-032
Other IDs
CPP 07/033 [UBET83]
Acronym
ATIM
Status last verified
Jun 2011
First submitted
2 Jun 2009
Last updated
22 Jun 2011
Results posted
No
Data monitoring committee
No

Publications

  • Beumer J 3rd, Roumanas E, Nishimura R. Advances in osseointegrated implants for dental and facial rehabilitation following major head and neck surgery. Semin Surg Oncol. 1995 May-Jun;11(3):200-7. doi: 10.1002/ssu.2980110305.

    PubMed 7638507

  • Birkfellner W, Solar P, Gahleitner A, Huber K, Kainberger F, Kettenbach J, Homolka P, Diemling M, Watzek G, Bergmann H. In-vitro assessment of a registration protocol for image guided implant dentistry. Clin Oral Implants Res. 2001 Feb;12(1):69-78. doi: 10.1034/j.1600-0501.2001.012001069.x.

    PubMed 11168273

  • Brosky ME, Korioth TW, Hodges J. The anterior cantilever in the implant-supported screw-retained mandibular prosthesis. J Prosthet Dent. 2003 Mar;89(3):244-9. doi: 10.1067/mpr.2003.43.

    PubMed 12644798

  • Casap N, Wexler A, Persky N, Schneider A, Lustmann J. Navigation surgery for dental implants: assessment of accuracy of the image guided implantology system. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):116-9. doi: 10.1016/j.joms.2004.06.028.

    PubMed 15332188

  • Casap N, Wexler A, Tarazi E. Application of a surgical navigation system for implant surgery in a deficient alveolar ridge postexcision of an odontogenic myxoma. J Oral Maxillofac Surg. 2005 Jul;63(7):982-8. doi: 10.1016/j.joms.2005.03.015.

    PubMed 16003627

  • Delannes M, Daly NJ, Bonnet J, Sabatier J, Tremoulet M. Fractionated radiotherapy of small inoperable lesions of the brain using a non-invasive stereotactic frame. Int J Radiat Oncol Biol Phys. 1991 Aug;21(3):749-55. doi: 10.1016/0360-3016(91)90695-z.

    PubMed 1869468

  • Esser E, Wagner W. Dental implants following radical oral cancer surgery and adjuvant radiotherapy. Int J Oral Maxillofac Implants. 1997 Jul-Aug;12(4):552-7.

    PubMed 9274085

  • Esser E, Neukirchen S, Wagner W. [Comparative studies of Branemark implants in the irradiated and not irradiated mandible]. Mund Kiefer Gesichtschir. 1999 May;3 Suppl 1:S125-9. doi: 10.1007/PL00014498. German.

    PubMed 10414098

  • Fortin T, Coudert JL, Champleboux G, Sautot P, Lavallee S. Computer-assisted dental implant surgery using computed tomography. J Image Guid Surg. 1995;1(1):53-8. doi: 10.1002/(SICI)1522-712X(1995)1:13.0.CO;2-L.

    PubMed 9079427

  • Fortin T, Champleboux G, Lormee J, Coudert JL. Precise dental implant placement in bone using surgical guides in conjunction with medical imaging techniques. J Oral Implantol. 2000;26(4):300-3. doi: 10.1563/1548-1336(2000)0262.3.CO;2.

    PubMed 11831236

  • Fortin T, Champleboux G, Bianchi S, Buatois H, Coudert JL. Precision of transfer of preoperative planning for oral implants based on cone-beam CT-scan images through a robotic drilling machine. Clin Oral Implants Res. 2002 Dec;13(6):651-6. doi: 10.1034/j.1600-0501.2002.130612.x.

    PubMed 12519341

  • Fortin T, Bosson JL, Coudert JL, Isidori M. Reliability of preoperative planning of an image-guided system for oral implant placement based on 3-dimensional images: an in vivo study. Int J Oral Maxillofac Implants. 2003 Nov-Dec;18(6):886-93.

    PubMed 14696665

  • Fortin T, Isidori M, Blanchet E, Perriat M, Bouchet H, Coudert JL. An image-guided system-drilled surgical template and trephine guide pin to make treatment of completely edentulous patients easier: a clinical report on immediate loading. Clin Implant Dent Relat Res. 2004;6(2):111-9. doi: 10.1111/j.1708-8208.2004.tb00033.x.

    PubMed 15669711

  • Ganslandt O, Mueller R, Mueller W, Borchert H, Grabenbauer GG. Simple invasive fixation device for fractionated stereotactic LINAC based radiotherapy. Acta Neurochir (Wien). 2003 Apr;145(4):289-94; discussion 294. doi: 10.1007/s00701-003-0002-9.

    PubMed 12748889

  • Gill SS, Thomas DG, Warrington AP, Brada M. Relocatable frame for stereotactic external beam radiotherapy. Int J Radiat Oncol Biol Phys. 1991 Mar;20(3):599-603. doi: 10.1016/0360-3016(91)90076-g.

    PubMed 1995547

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic assessment -Radio-surgical guidance. in people with Upper Digestive Tract Cancer, run by Centre Leon Berard at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Insufficient recruitment, too much selective inclusion criteria, feasibility problems). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of implants insertion, radio-surgical guidance. (time frame: 8 months after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00925509, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2011.

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