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Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors
Phase 3 trial testing conventional surgery in Childhood Embryonal Tumor in 302 participants. Completed in 30 June 2021.
| Lead sponsor | Children's Oncology Group |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 302 |
| Start date | 3 November 2003 |
| Primary completion | 1 October 2013 |
| Estimated completion | 30 June 2021 |
| Sites | 126 locations across New Zealand, Canada, Puerto Rico, Australia, Switzerland, United States |
Children's Oncology Group — full company profile →
Under 21, any sex, with Childhood Embryonal Tumor or Childhood Extracranial Germ Cell Tumor. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of patients event free at 3 years following enrollment. Event-free survival is not a primary outcome measure for Arm 2 patients.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 | 87.0 | 81.0 – 92.0 |
Percentage probability of being alive at 3 years following enrollment.
| Group | Value | 95% CI |
|---|---|---|
| Arm I | 97.0 | 93.0 – 99.0 |
| Arm 2 | 99.0 | 92.8 – 99.9 |
Calculated to quantify the treatment cost associated with this regimen.
| Group | Value | 95% CI |
|---|---|---|
| Arm I | 14.08 | ± 10.27 |
The number of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher at any time during protocol therapy
| Group | Value | 95% CI |
|---|---|---|
| Arm I | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Arm I | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Arm I | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Arm I | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Arm I | 58 |
| Group | Value | 95% CI |
|---|---|---|
| Arm I | 10 |
| Group | Value | 95% CI |
|---|---|---|
| Arm I | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Arm I | 1 |
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm 2 (Observation) | Arm I (Chemotherapy) |
|---|---|---|---|
| Neutrophil count decreased | Investigations | — | — |
| White blood cell decreased | Investigations | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Infections and infestations - Other, specify | Infections and infestations | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Fever | General disorders | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Catheter related infection | Infections and infestations | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Encephalopathy | Nervous system disorders | — | — |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | — | — |
| Hearing impaired | Ear and labyrinth disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Non-cardiac chest pain | General disorders | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — |
| Syncope | Nervous system disorders | — | — |
| Wound infection | Infections and infestations | — | — |
| Ileus | Gastrointestinal disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
Data from ClinicalTrials.gov NCT00053352 adverse events section.
This phase III trial is studying surgery followed by combination chemotherapy to see how well it works in treating children with germ cell tumors that are not located in the head. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is effective in decreasing the recurrence of childhood germ cell tumors.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing