Monday, June 11, 2017, our latest developments on Intraoperative Photodynamic Therapy for the treatment of Glioblastoma (INDYGO) has been presented at the PDT in Neurology-Brain Session during the lastest IPA congress.
Set-up of the clinical trial and first experiments on intraoperative 5-ALA PDT on newly diagnosed glioblastoma were introduced by M. Vermandel (ONCO-THAI U1189 - Inserm - Université de Lille - CHRU de Lille).
Set-up of the clinical trial and first experiments on intraoperative 5-ALA PDT on newly diagnosed glioblastoma were introduced by M. Vermandel (ONCO-THAI U1189 - Inserm - Université de Lille - CHRU de Lille).
Abstract:
Glioblastoma (GBM) still remains an incurable brain tumor with a median overall survival of approximately 15 months. Complete tumor resection is rarely feasible, since tumor cells usually infiltrate brain surrounding tumor core. Adjuvant therapies to improve local control are thus highly expected. Management of newly diagnosed GBM includes surgery for maximal tumor resection followed by radiation therapy and concomitant and adjuvant chemotherapy. Recently, 5-ALA interstitial photodynamic therapies have been reported with promising results . However, if one consider the absence of controlled clinical trial, efficacy of 5-ALA PDT is not still evidenced and thus not included in the standard protocol. We present here the set-up of a clinical trial to evaluate the feasibility of 5-ALA PDT to treat newly diagnosed GBM.
Our group has recently developed a new intraoperative technique (2) to deliver PDT during the course of surgery. Thus, Intraoperative PDT becomes a seamless strategy embeddable into the standard surgical protocol. Our clinical trial received positive opinions from institutional review boards and from the french national medicine agency and is now recruiting with first inclusions scheduled in February 2017 (EudraCT number: 2016-002706-39/ clinical trial.org).
Ten patients will be enrolled and will undergo to intraoperative PDT in addition to the standard of care. PDT will be delivered early after surgery.
Primary endpoint is the feasibility of intraoperative PDT, estimated by the proportion of patients who undergone intraoperative PDT without unacceptable toxicity. Secondary endpoints are progression-free survival, overall survival and patients' quality of life.
Glioblastoma (GBM) still remains an incurable brain tumor with a median overall survival of approximately 15 months. Complete tumor resection is rarely feasible, since tumor cells usually infiltrate brain surrounding tumor core. Adjuvant therapies to improve local control are thus highly expected. Management of newly diagnosed GBM includes surgery for maximal tumor resection followed by radiation therapy and concomitant and adjuvant chemotherapy. Recently, 5-ALA interstitial photodynamic therapies have been reported with promising results . However, if one consider the absence of controlled clinical trial, efficacy of 5-ALA PDT is not still evidenced and thus not included in the standard protocol. We present here the set-up of a clinical trial to evaluate the feasibility of 5-ALA PDT to treat newly diagnosed GBM.
Our group has recently developed a new intraoperative technique (2) to deliver PDT during the course of surgery. Thus, Intraoperative PDT becomes a seamless strategy embeddable into the standard surgical protocol. Our clinical trial received positive opinions from institutional review boards and from the french national medicine agency and is now recruiting with first inclusions scheduled in February 2017 (EudraCT number: 2016-002706-39/ clinical trial.org).
Ten patients will be enrolled and will undergo to intraoperative PDT in addition to the standard of care. PDT will be delivered early after surgery.
Primary endpoint is the feasibility of intraoperative PDT, estimated by the proportion of patients who undergone intraoperative PDT without unacceptable toxicity. Secondary endpoints are progression-free survival, overall survival and patients' quality of life.
