One Year Overall Survival
Primary
· One year
Estimated one year survival using the Kaplan-Meier methodology.
| Group | Value | 95% CI |
|---|---|---|
| Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 0.7208 | 0.6237 – 0.7968 |
Last reviewed · How we verify
NCT00100802
Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas
Completed
Phase 2
Results posted
Last updated 15 February 2023
What this trial tests
Phase 2 trial testing Laboratory Biomarker Analysis in Anaplastic Astrocytoma in 118 participants. Completed in 30 June 2017.
Timeline
21 March 2005
Primary endpoint
1 September 2012
1 September 2012
30 June 2017
Quick facts
| Lead sponsor | Children's Oncology Group |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 118 |
| Start date | 21 March 2005 |
| Primary completion | 1 September 2012 |
| Estimated completion | 30 June 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Laboratory Biomarker Analysis — full drug profile →
- Lomustine (LOMUSTINE) — full drug profile →
- Radiation Therapy — full drug profile →
- Temozolomide (temozolomide) — full drug profile →
Conditions studied
- Anaplastic Astrocytoma — all drugs for Anaplastic Astrocytoma →
- Central Nervous System Neoplasm — all drugs for Central Nervous System Neoplasm →
- Glioblastoma — all drugs for Glioblastoma →
- Gliosarcoma — all drugs for Gliosarcoma →
Sponsor
Children's Oncology Group — full company profile →
Who can join
Adults 3 to 21, any sex, with Anaplastic Astrocytoma or Central Nervous System Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Occurrence of Death Attributable to Complications of Protocol Therapy
Primary
· While receiving protocol therapy (up to 301 days excluding delays) or within 30 days of Termination of Protocol Therapy
Number of deaths due to complications of protocol therapy.
| Group | Value | 95% CI |
|---|---|---|
| Surgery, Chemoradiotherapy, Rest, Maintenance, FUP | 1 |
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Surgery, Chemoradiotherapy, Rest, Maintenance, FUP
Serious: 3/106 (3%)
Deaths: —
Serious adverse events (3 terms)
| Reaction | System | Surgery, Chemoradiotherapy… |
|---|---|---|
| Neutrophil count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
Other adverse events (73 terms — click to expand)
| Reaction | System | Surgery, Chemoradiotherapy… |
|---|---|---|
| Neutrophil count decreased | Investigations | — |
| Platelet count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Lymphocyte count decreased | Investigations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Seizure | Nervous system disorders | — |
| Depressed level of consciousness | Nervous system disorders | — |
| Fatigue | General disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Infections and infestations - Other, specify | Infections and infestations | — |
| Headache | Nervous system disorders | — |
| Peripheral motor neuropathy | Nervous system disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Blood bilirubin increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Dysphasia | Nervous system disorders | — |
| Hydrocephalus | Nervous system disorders | — |
| Memory impairment | Nervous system disorders | — |
| Nervous system disorders - Other, specify | Nervous system disorders | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Dysphagia | Gastrointestinal disorders | — |
| Allergic reaction | Immune system disorders | — |
| Skin infection | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| GGT increased | Investigations | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Depression | Psychiatric disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Thromboembolic event | Vascular disorders | — |
| Hemolysis | Blood and lymphatic system disorders | — |
| Cushingoid | Endocrine disorders | — |
| Endocrine disorders - Other, specify | Endocrine disorders | — |
| Extraocular muscle paresis | Eye disorders | — |
| Eye disorders - Other, specify | Eye disorders | — |
| Papilledema | Eye disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
Most-reported serious reactions: Neutrophil count decreased, White blood cell decreased, Anorexia.
Data from ClinicalTrials.gov NCT00100802 adverse events section.
Sponsor's own description
This phase II trial is studying how well giving radiation therapy together with temozolomide and lomustine works in treating young patients with newly diagnosed gliomas. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide and lomustine after surgery may kill any remaining tumor cells.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Recent advances and new discoveries in the pipeline of the treatment of primary spinal tumors and spinal metastases: a scoping review of registered clinical studies from 2000 to 2020.
Furlan JC, Wilson JR, Massicotte EM, Sahgal A, et al · · 2022 · cited 24× · PMID 34508647 · DOI 10.1093/neuonc/noab214 -
Trial Design Challenges and Approaches for Precision Oncology in Rare Tumors: Experiences of the Children's Oncology Group.
Renfro LA, Ji L, Piao J, Onar-Thomas A, et al · · 2019 · cited 17× · PMID 32923863 · DOI 10.1200/po.19.00060 -
Molecular profiling of pre- and post-treatment pediatric high-grade astrocytomas reveals acquired increased tumor mutation burden in a subset of recurrences.
Wood MD, Beadling C, Neff T, Moore S, et al · · 2023 · cited 5× · PMID 37670377 · DOI 10.1186/s40478-023-01644-4 -
Children's Oncology Group's 2023 blueprint for research: Central nervous system tumors.
Leary SES, Onar-Thomas A, Fangusaro J, Gottardo NG, et al · · 2023 · cited 4× · PMID 37534382 · DOI 10.1002/pbc.30600
Verify or expand the search:
- PubMed search for NCT00100802
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Laboratory Biomarker Analysis
Trials testing the same drug.
- NCT04142398 — Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men · withdrawn
- NCT04142385 — Incidence of HIV Infection in Screening Indian Men Who Have Sex With Men · withdrawn
- NCT05558904 — An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cance · Phase 1, PHASE2 · recruiting
- NCT05564650 — Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome · Phase 1 · active not recruiting
- NCT05396859 — Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia · Phase 1 · active not recruiting
Other recruiting trials for Anaplastic Astrocytoma
Currently open trials in the same condition.
- NCT07448480 — Comprehensive Analysis of Chemotherapy and Targeted Therapy Outcomes in Recurrent Malignant Gliomas · active not recruiting
- NCT06333899 — Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion · EARLY_PHASE1 · recruiting
- NCT05956821 — Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age · Phase 1, PHASE2 · recruiting
- NCT05843253 — Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant · Phase 2 · recruiting
- NCT05839379 — Targeted Pediatric High-Grade Glioma Therapy · recruiting
Other Children's Oncology Group trials
Trials by the same sponsor.
- NCT07412002 — Quality of End-of-Life Care for Children With Cancer · not yet recruiting
- NCT07498465 — A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant · Phase 1 · withdrawn
- NCT07022678 — Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia · Phase 3 · not yet recruiting
- NCT07072585 — Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leuk · Phase 2, PHASE3 · not yet recruiting
- NCT06858501 — Comparing 123I-MIBG and 18F-MFBG Imaging in Patients With Newly Diagnosed, High Risk Neuroblastoma · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT00100802 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Oncology Group
- Last refreshed: 15 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00100802.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing