JCOG2303: A randomized phase III study of preserving adjuvant chemoradiation therapy in patients with radically resected IDH-mutant astrocytoma (PATIENT)
JCOG2303: A randomized phase III study of preserving adjuvant chemoradiation therapy for radically resected astrocytoma (PATIENT)
MURAGAKI Yoshihiro
Kobe University Hospital
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017 Japan
+81-78-382-2601
muragaki@people.kobe-u.ac.jp
SASAYAMA Takashi
Kobe University Hospital
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017 Japan
+81-78-382-5966
takasasa@med.kobe-u.ac.jp
Recruiting
July. 26, 2024
Aug. 03, 2024
270
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
treatment purpose
The first registration criteria
(1) The most recent intraoperative rapid pathology at the time of surgery or permanent pathology of a surgically removed specimen performed prior to enrollment has a diagnosis of Grade 2 or Grade 3 glioma.
(2) It is possible to submit the surgical specimens necessary for the diagnosis of (a) and (b) below.
(a) Central pathology diagnosis
(b) Molecular central diagnosis to determine IDH mutation, 1p19q co-deletion, and CDKN2A/B homozygous deletion
(3) Tumor removal of more than 90% of the maximum tumor volume from the date of initial diagnosis including outside institutions to before the latest surgery is confirmed on the latest postoperative contrast-enhanced and FLAIR image of the brain.
(4) Any previous glioma surgery is acceptable.
(5) Within 21 days from the most recent glioma surgery (registration up to day 21 is acceptable with the date of surgery as day 0).
(6) Tumor is located within the cerebrum on the most recent preoperative contrast-enhanced MRI of the head.
(7) No multiple lesions or disseminated lesions on the most recent preoperative contrast-enhanced MRI of the head.
(8) The existence of measurable lesions is not required.
(9) Age 18 years or older on the date of primary enrollment.
(10) Performance status (PS) is either 0-2 on the ECOG scale or PS 3 due solely to neurological symptoms caused by the tumor (PS must be documented in the medical record).
(11) No prior chemotherapy (including carmustine intracerebral implant) or radiation therapy for intracranial tumors.
(12) No history of chemotherapy or radiation therapy to the head, including treatment for other types of cancer.
(13) The most recent laboratory values within 21 days prior to primary enrollment (the same day of the week 3 weeks prior to the date of enrollment is acceptable) meet all of the following
(a) Neutrophil count >= 1,500/mm3
(b) Hemoglobin >=9.0 g/dL (no blood transfusion within 14 days prior to the blood draw for the test used for registration)
(c) platelet count >=100,000/mm3
(d) AST<=120 U/L
(e) ALT<=120 U/L
(f) Serum creatinine <=1.605 mg/dL (male), <=1.185 mg/dL (female)
(14) Written consent to participate in the study has been obtained from the patient him/herself. However, in case the patient is able to understand and agree to the explanation and is unable to sign the document due to neurological symptoms, a substitute author may sign the document confirming the patient's consent.
The second registration criteria
(1) The patient has already undergone the first registration process. The secondary registration day is within 56 days of the most recent glioma surgery (enrollment up to day 56 is acceptable with the surgery day set as day 0).
(2) Based on the results of central pathological and molecular diagnoses, the patient has a diagnosis of IDH-mutant astrocytoma Grade 3 (WHO Classification of Brain Tumors, 5th edition).
(1) Synchronous or metachronous (within 2 years) malignancies.
(2) Infections which needs systemic treatment.
(3) Body temperature is higher than 38 degrees centigrade at registration.
(4) Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding. Men who wish for their partners to become pregnant.
(5) Severe psychological disease.
(6) Continuous systemic corticosteroid or immunosuppressant treatment due to the diseases except for brain tumor.
(7) Uncontrollable diabetes mellitus.
(8) Unstable angina pectoris, or history of myocardial infarction within 6 months.
(9) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest X-p.
(10) Gadolinium allergy.
(11) Positive HBs antigen.
(12) Positive HIV antibody.
18age old over
No limit
Both
Glioma
Group A: Standard treatment group [Adjuvant chemoradiation therapy] / Group B: Experimental treatment group [Watch & Wait strategy]
Overall survival
Progression-free survival, chemotherapy/radiotherapy-free survival, Malignant transformation-free survival, Progression-free survival after chemoradiation with temozolomide,
Proportion of adverse events, proportione of patients with no neurocognitive decline, proportion of patients with no decline of health-related quality of life, Employment rate
National Cancer Center Japan
Japan Agency for Medical Research and Development
National Cancer Center Hospital Certified Review Board
