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History of Changes for Study: NCT04391062
Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma (DOSINDYGO)
Latest version (submitted October 4, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 12, 2020 None (earliest Version on record)
2 May 20, 2020 Contacts/Locations, Study Design and Study Status
3 April 22, 2021 Study Status
4 September 16, 2021 Recruitment Status, Study Status, Contacts/Locations, Oversight and Sponsor/Collaborators
5 October 4, 2021 Recruitment Status, Study Status and Contacts/Locations
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Study NCT04391062
Submitted Date:  May 12, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2018_58
Brief Title: Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma (DOSINDYGO)
Official Title: A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma
Secondary IDs: 2019-004796-40 [EudraCT Number]
2019-A03157-50 [ID-RCB number, ANSM]
Open or close this module Study Status
Record Verification: May 2020
Overall Status: Not yet recruiting
Study Start: July 2020
Primary Completion: July 2023 [Anticipated]
Study Completion: July 2023 [Anticipated]
First Submitted: May 12, 2020
First Submitted that
Met QC Criteria:
May 12, 2020
First Posted: May 18, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
May 12, 2020
Last Update Posted: May 18, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University Hospital, Lille
Responsible Party: Sponsor
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The phase II study evaluate a light dose escalation in a classical intraoperative PDT regimen mediated by 5-ALA-PpIX, in glioblastoma patients with access to full surgical removal of the contrast enhancement. This treatment will be performed in addition to the current reference treatment of glioblastoma: maximum removal surgery followed by radiochemotherapy according to the Stupp protocol.
Detailed Description:
Open or close this module Conditions
Conditions: Glioblastoma
Keywords: Surgical indication of glioblastoma
Glioblastoma
Photodynamic Therapy
Neurosurgery
Oncology
5-aminolevulinic Acid
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Sequential Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 21 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: intraoperative PDT 400J/cm² Drug: Gliolan
patient will receive 5-ALA 4 to 6 hours before surgery
Device: Intraoperative PDT

The protocol requires the realization of specific procedures in addition to the usual care.

The intra-operative photodynamic therapy ("intraoperative PDT") added to surgery for glioblastoma excision. The patient will receive 5-ALA ( 5-aminolevulinic acid hydrochloride),GLIOLAN drinkable 6h before surgery + lighting of the tumor bed by a red light source (laser with different J/cm²) at the end of resection (Prolonged surgery of 45 minutes).

Experimental: intraoperative PDT 600J/cm² Drug: Gliolan
patient will receive 5-ALA 4 to 6 hours before surgery
Device: Intraoperative PDT

The protocol requires the realization of specific procedures in addition to the usual care.

The intra-operative photodynamic therapy ("intraoperative PDT") added to surgery for glioblastoma excision. The patient will receive 5-ALA ( 5-aminolevulinic acid hydrochloride),GLIOLAN drinkable 6h before surgery + lighting of the tumor bed by a red light source (laser with different J/cm²) at the end of resection (Prolonged surgery of 45 minutes).

Experimental: intraoperative PDT 800J/cm² Drug: Gliolan
patient will receive 5-ALA 4 to 6 hours before surgery
Device: Intraoperative PDT

The protocol requires the realization of specific procedures in addition to the usual care.

The intra-operative photodynamic therapy ("intraoperative PDT") added to surgery for glioblastoma excision. The patient will receive 5-ALA ( 5-aminolevulinic acid hydrochloride),GLIOLAN drinkable 6h before surgery + lighting of the tumor bed by a red light source (laser with different J/cm²) at the end of resection (Prolonged surgery of 45 minutes).

Open or close this module Outcome Measures
Primary Outcome Measures:
1. Maximum Tolerated Dose-Light Level (MTDL) defined as the light dose associated with an acceptable dose-limiting toxicity level (TDL)
[ Time Frame: 4 weeks (+/-3 days) post-PDT. ]

Dose level above which TDL is observed in more than 33% (i.e., d̀-> 2 of 6) of subjects in an arm
Secondary Outcome Measures:
1. Progression Free Survival (PFS)
[ Time Frame: From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months ]

Number of patients without relapse within 25 mm of surgical site defined according to International RANO criteria
2. Global Progression Free Survival (PFS)
[ Time Frame: From the Date of diagnosis of glioblastoma until the date of Relapse, an average 18 months ]

Median of progression-free survival time determined according to international RANO criteria
3. Overall Survival (OS)
[ Time Frame: From the Date of diagnosis of glioblastoma until the death, an average 18 months ]

Median of OS determined according to international RANO criteria
4. Response to treatment
[ Time Frame: every 3 months between the Date of intraoperative PDT until relapse/death, an average 18 months ]

Evaluated by MRI/ TEP 11C-MET every 3 months
5. Incidence of "intraoperative PDT" treatment-emergent Adverse Events
[ Time Frame: From the beginning of treatment with intraoperative PDT up to relapsing/death, an average 18 months ]

Collection of all Adverse events (AEs and SAEs) (according to NCI-CTCE V5.0) and reviewing by an Independent Safety Monitoring Board
6. Quality of Life Questionnaire -C30 ( QLQ-C30
[ Time Frame: Every 3 months from the signature of Consent form until relapse/death, an average 18 months ]

The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items
7. Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20)
[ Time Frame: Every 3 months from the signature of Consent form until relapse/death, an average 18 months ]

Measuring the health-related quality of life in patients with brain cancer
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • General status (WHO) Karnofsky Performance Status ≥60
  • Presumptive glioblastoma according to radiological criteria,
  • Surgical indication decided in Multidisciplinary consultation meeting (RCP) of neuro oncology,
  • Decision to treat the patient as part of the Clinical trial achieved in neuro-oncology RCP ("Multidisciplinary consultation meeting")
  • Patient operable on the basis of absence of cardiopulmonary disease history; a complete medical check-up sufficient to insure a post-operative state with normal daily life
  • Clinical neuro-oncological monitoring and long-term MRI/ TEP 11C MET scheduled at the hospital centers
  • Patient able to understand and sign voluntarily Informed consent
  • Patient able to adhere to the visit's calendar of the study and other imperatives of the protocol
  • Women of child-bearing potential should benefit of an effective contraception
  • For patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ALA

Exclusion Criteria:

  • Contraindications to 5-ALA (Gliolan®) and to intra-operative PhotoDynamic Therapy "intraoperative PDT":
  • Contraindications to 5-ALA
    • Porphyria
    • Taking photosensitizer treatment
    • Severe renal or hepatic impairment
    • Bilirubin> 1.5 x maximum level, Alkaline Phosphatases and transaminases (ASAT)> 2.5 x Maximum. rates
    • Creatinine clearance <30 mL / min;
    • Non-compliance with the rules of prevention of the transient risk of cutaneous photosensitization
  • Contraindications to surgery
  • Contraindications to magnetic resonance imaging (MRI/TEP 11C MET
  • Treatment with an experimental drug within 30 Days prior to the start of the study
  • Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons,
  • Legal incapacity (persons deprived of their liberty or Guardianship or guardianship),
  • Pregnant or nursing women
  • Refusal to participate or sign the consent of the study
  • Soy allergy
Open or close this module Contacts/Locations
Central Contact Person: Nicolas Reyns, MD,PhD
Telephone: +33320446721
Email: nicolas.reyns@chru-lille.fr
Central Contact Backup: Maximilien Vermandel, MD
Telephone: +33320446721
Email: maximilien.vermandel@chru-lille.fr
Study Officials: Nicolas Reyns, MD,PhD
Principal Investigator
University Hospital, Lille
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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