A Phase 3 interventional study of Temozolomide in Glioblastoma, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-04-02.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Phase 3, Interventional, and Treatment
This study is a prospective, multi-center, randomized controlled clinical study. Indications: Glioblastoma diagnosed after surgery (WHO grade IV). The patient received conventional postoperative concurrent radiotherapy and chemotherapy, or neoadjuvant temozolomide combined with concurrent increased intensity-modulated radiotherapy. According to data from previous clinical trials, conventional doses of concurrent radiotherapy and chemotherapy PFS 6.9 months neoadjuvant temozolomide combined with concurrently increased intensity-modulated radiotherapy PFS 13.7 months, an estimated 20% leakage rate, and a total sample size of 80 patients.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's planned enrollment of 80 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.
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Exclusion Criteria:
1. New auxiliary TMZ period: oral TMZ 75mg/m2, qd, continued until the beginning of radiotherapy. 2. Concurrent radiotherapy and chemotherapy period: 4 weeks in total. Prior to treatment, radiotherapy positioning and planning were established, using SIB-IMRT technology, the irradiation range, the tumor residual area 60Gy/20f/4w, the tumor bed area 40Gy/20f/4w, 1 time/d, 5 times/w. During radiotherapy, TMZ will continue to be administered orally simultaneously, the specific dose: TMZ 75mg/m2 qd, until 42 days. 3. Intermediate rest period: 4 weeks in total. ;4. TMZ adjuvant chemotherapy period: 6 to 12 months in total. Cycle 1: TMZ 150mg/m2, d1-5, q28d; if the patient can tolerate it, cycles 2-12: TMZ 200mg/m2, d1-5, q28d; after cycles 3, 6, 9, and 12 of adjuvant chemotherapy Head functional magnetic resonance examination was performed to assess the size of residual lesions and edema.
Combination Product: Temozolomide
1. Concurrent radiotherapy and chemotherapy period: 6 weeks in total. Radiotherapy positioning and planning before treatment, using CRT technology, irradiation range, tumor bed area, 60Gy/30f/6w, 1 time/d, 5 times/w, simultaneous TMZ oral administration on the first day of radiotherapy, specific dose: TMZ 75mg/m2 qd for 42 consecutive days; head functional magnetic resonance imaging was performed at the end of radiotherapy to assess the size of residual lesions and edema. 2. Intermediate rest period: 4 weeks in total. The patient will go to the hospital to recheck blood routine every week;3. TMZ adjuvant chemotherapy period: 6 to 12 months in total. Cycle 1: TMZ 150mg/m2, d1-5, q28d; if the patient can tolerate it, cycles 2-12: TMZ 200mg/m2, d1-5, q28d; head functional magnetic resonance imaging was performed after adjuvant chemotherapy in cycles 3, 6, 9, and 12 to assess the size of residual lesions and edema.
Combination Product: Temozolomide
The patient received neoadjuvant temozolomide combined with simultaneous increase in intensity-modulated radiotherapy. According to data from previous clinical trials, neoadjuvant temozolomide combined with concurrently increased intensity-modulated radiotherapy PFS for 13.7 months.
Also known as: Intensity-Modulated Radiotherapy
Objective response rate
RANO criteria: evaluate the therapeutic effect of glioma through MRI and clinical manifestations.
Time frame: Two years after all treatments are over
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School