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NCT Number: NCT01811121

MEDICO-ECONOMIC EVALUATION OF SURGERY GUIDED BY FLUORESCENCE FOR THE OPTIMIZATION OF RESECTION OF GLIOBLASTOMAS

Glioblastoma is the most frequent primary malignant brain tumor in adults (3,000 new cases per year) and is characterized by a poor prognosis (median survival 12 months). Treatment is based mainly on surgical excision as complete as possible followed by an additional radiochemotherapy. The prognosis depends mainly on the quality of resection when it is macroscopically complete. Different techniques to support the surgical resection have been developed over the past 20 years. The reference technique is currently the intraoperative neuronavigation for guiding excision by matching the intraoperative tumor boundaries with those of the preoperative MRI. Its main drawback is the loss of precision during the resection related to changes in anatomical limits of the tumor.

The per-operative fluorescence-guided surgery (FGS) is an innovative alternative technique to support the surgical resection. The 5-aminolevulinic acid (5-ALA), a molecule absorbed by the patient before surgery is captured specifically by the tumor cells and transformed into a fluorochrome revealed intraoperatively by a light source length adapted wave with a set of lenses included in the microscope. Resection is thus guided by this fluorescence whose disappearance translates complete tumor resection.

Its interest is twofold:

* Increase the percentage of complete tumor resection. * Improve disease-free survival and overall survival. The objective of the study is to compare the FGS to the intraoperative neuronavigation for the resection of glioblastoma, on a medical and economical level through a randomized, prospective, multicenter trial.

The annual number of patients likely to benefit of this technique in France is estimated at 2200 new cases.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Guyotat

Lyon, France

About this study

Main Outcome Measure: Percentage of patients with surgical resection of the tumor is complete, objectified by the absence of residual tumor on MRI early postoperative (within 48 hours) by a central committee of independent reading with qualitative analysis taking a contrast replay console for diagnostic use

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age greater than 18 years with no upper age limit
  • Competent adult patient.
  • Patient affiliated to the National Health Insurance.
  • Patient with an intra-cerebral supra-tentorial hemispheric, newly diagnosed and previously untreated, which MRI characteristics are suggestive of a glioblastoma.
  • Indication for surgical treatment by excision.
  • Brain tumor location distant from critical functional areas allowing a wide resection of contrast enhancement on imaging, the a priori character completely resectable has been validated by an evaluation committee composed of three surgeons
  • No-cons contain medical surgery, ASA score below 4.
  • Patient eligible for further treatment by radiotherapy and concurrent chemotherapy followed by adjuvant chemotherapy according to the so called Stupp scheme (standard protocol of adjuvant chemoradiotherapy)
  • Negative pregnancy test for women of childbearing age.

Exclusion criteria

  • Contraindications to performing an MRI (pacemaker).
  • Glioblastoma known and previously treated with surgery, radiotherapy and / or chemotherapy.
  • History of cancer.
  • Anatomical Location of the tumor-cons indicating a wide excision, neurosurgeon at the discretion of medical officer participating center.
  • Location tumor in the brain stem, the middle line, the basal ganglia and the posterior cranial fossa.
  • Patient with cons-indication to the achievement of further treatment with radiotherapy and concurrent chemotherapy followed by adjuvant chemotherapy according to the scheme proposed by Stupp. (1)
  • Patients with porphyria, renal insufficiency (creatinine> 177 μmolL), liver insufficency(gamma glutamyl transpeptidase> 100 U / L, prothrombin time <60%, bilirubin> 51μmol / L).
  • Patient refused to sign an informed consent form.
  • Ongoing participation of the patient to another clinical trial.

Treatment and study plan

5-aminolévulinique acid (5-ALA)

Drug

oral administration of 20mg/kg of 5-ALA 3-5 hours before the surgical incision

Other names: Bras A

Placebo

Drug

Oral administration of 1g of ascorbic acid LAROSCORBINE in 50ml of water 3 hours before surgery

Other names: Bras B

Primary outcomes

  1. Comparison of complete tumor resection between the 2 arms

    Time frame: 48 hours

    Evidenced of complete resection (absence of residual tumor on early postoperative MRI (within 48 hours)) will be assessed by a central independent committee with qualitative analysis of contrast enhancement replay on a console for diagnostic use.

Secondary outcomes

  1. Comparison of complete tumor resection between the 2 arms

    Time frame: less than 48 hours after surgery

    Evidenced of complete resection (absence of residual tumor on early postoperative MRI (within 48 hours)) will be assessed by the neurosurgeon who conducted the surgery and the neuro-radiologist who conducted the RMI with qualitative analysis of contrast enhancement replay during the initial clinical analysis

Other outcomes

  1. Diagnostic value of the two intraoperative techniques

    Time frame: 60 months

    Evaluate the sensitivity, specificity, positive predictive value and negative by correlating the results of pathological analysis of resection edge with intraoperative findings of the surgeon at the end of resection.

  2. Quantification of residual tumor (contrast enhancement) on MRI post-opératre early (before 48 hours)

    Time frame: before 48 hours

    It will be performed by three study investigators (Dr. Pallud, Department of Neurosurgery, Centre Hospitalier Sainte-Anne, Paris; Dr. Guyotat, D department of Neurosurgery, Hospices Civils de Lyon, Lyon, Dr. Metellus, neurosurgery department, Assistance Publique - Hôpitaux de Marseille) and read separately. The volume analysis will be done by segmentation using the OsiriX software on postoperative MRI and MRI pre-operative

  3. Progression Free survival rate at 6 months

    Time frame: 6 months

    Progression is defined by the appearance of a new tumor lesion which minimum volume will be set to 0.175 cm3, by the increase of the residual tumor volume of 25% or more, or by the need to increase corticosteroid therapy. The period of progression free survival is defined as the time from the date of tumor resection and date of diagnosis of tumor progression or the date last news or date of endpoint. Progression Free survival rate at 6 months will be analyzed according to surgical approach used, according to the completeness or incompleteness of resection and by centers

  4. Overall survival at 24 months

    Time frame: 24 months

    It will be estimated from the number of patients who died of whatever cause. The overall survival time is defined as the time between the date of tumor resection and date of death from any cause or date of last news or the date of endpoint. The overall survival at 24 months will be analyzed according to surgical approach used, according to the completeness or incompleteness of resection and by centers.

  5. Overall survival at 60 months

    Time frame: 60 months

    It will be estimated from the number of patients who died of whatever cause. The overall survival time is defined as the time between the date of tumor resection and date of death from any cause or date of last news or the date of endpoint. The overall survival at 60 months will be analyzed according to surgical approach used, according to the completeness or incompleteness of resection and by centers.

  6. Evaluation of Quality of life

    Time frame: every 3 months

    Evaluation of quality of life every 3 months using the EORTC questionnaire QLQ-C30 with the specific brain tumors module BN20.

  7. Evaluation of early and late morbidity

    Time frame: in 8 days and late morbidity at 3 months

    Evaluation of early morbidity in 8 days and late morbidity at 3 months (neurological deficit, surgical site infection, secondary epilepsy, Karnofsky score, performance status WHO).

  8. Comparison of surgical procedure duration between the 2 arms

    Time frame: 60 months

  9. Medico-economic evaluation of the 2 procedure

    Time frame: 60 months

    Comparison of the differential cost effectiveness ratio between the 2 strategies

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Randomized, Prospective, Multicenter Blinding Singles With Arm A and Arm B Innovative Strategy Strategy Conventional

Acronym: RESECT

Important dates

Study start
2013
Primary completion
2013
Study completion
2019
First posted
Mar 14, 2013
Registry last updated
Sep 15, 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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