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NCT00274950
Protocol for the Treatment of Extracranial Germ Cell Tumours in Children and Adolescents (GC III)
Phase 3 trial testing bleomycin sulfate in Childhood Germ Cell Tumor in 105 participants. Status unknown.
1 May 2010
Quick facts
| Lead sponsor | Children's Cancer and Leukaemia Group |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 105 |
| Start date | 1 May 2005 |
| Primary completion | 1 May 2010 |
| Sites | 20 locations across Ireland, United Kingdom |
Drugs / interventions tested
- bleomycin sulfate — full drug profile →
- carboplatin (Carboplatin) — full drug profile →
- cisplatin (cisplatin) — full drug profile →
- etoposide (etoposide) — full drug profile →
- ifosfamide
- vinblastine sulfate
- adjuvant therapy — full drug profile →
- conventional surgery
Conditions studied
- Childhood Germ Cell Tumor — all drugs for Childhood Germ Cell Tumor →
- Extragonadal Germ Cell Tumor — all drugs for Extragonadal Germ Cell Tumor →
- Ovarian Cancer — all drugs for Ovarian Cancer →
Sponsor
Children's Cancer and Leukaemia Group — full company profile →
Who can join
Under 17, any sex, with Childhood Germ Cell Tumor or Extragonadal Germ Cell Tumor. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- Event-free survival
- Continuation of treatment
- Development of common and follow-up strategies
- Registration of all cases of mature and immature teratoma
Sponsor's own description
RATIONALE: Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This phase III trial is studying how well observation and/or combination chemotherapy works after surgery or biopsy in treating young patients with extracranial germ cell tumors.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00274950
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of bleomycin sulfate
Trials testing the same drug.
- NCT01026220 — Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma · Phase 3 · completed
- NCT00678327 — Fludeoxyglucose F 18-PET/CT Imaging in Assessing Response to Chemotherapy in Patients With Newly Diagnosed Stage II, Sta · Phase 3 · completed
- NCT00104676 — Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors · Phase 3 · completed
- NCT00053352 — Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors · Phase 3 · completed
- NCT00002565 — Combination Chemotherapy in Treating Patients With Intermediate-Grade or Immunoblastic Non-Hodgkin's Lymphoma · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00274950 (US National Library of Medicine, public domain)
- 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 Cancer and Leukaemia Group
- Last refreshed: 16 September 2013
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/NCT00274950.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing