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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-009882-33 | EudraCT Number |
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| Name | Class |
|---|---|
| University College London Hospitals | OTHER |
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This study evaluated the safety, efficacy and toxicity of carboplatin area under the curve (AUC)-10 in metastatic seminoma to see if, by using fluoro-deoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) to assess metabolic response, the number of patients requiring 4 cycles can be reduced. Carboplatin AUC-10 was given every 21 days. A PET-CT scan was carried out on day 17-21 of the first cycle. If the PET - CT scan showed a complete response patients received 3 cycles of treatment. If the PET - CT scan did not show a complete response patients received 4 cycles of treatment. After treatment, patients were followed up for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carboplatin AUC-10 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin AUC-10 | Drug | Carboplatin AUC-10 according to the Calvert formula [10 x (glomerular filtration rate (ml/min) + 25)]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| 2 - Year Progression Free Survival | Number of participants progression free 2 years after registration. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Response Rate | Number of participants achieving i) complete metabolic response (CR) and ii) partial metabolic response (PR) after one cycle of treatment. | 21 days |
| Overall Survival | Survival status at 2 years after registration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Shamash, MD FRCP | Barts & The London NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts Health NHS Trust | London | EC1A 7BE | United Kingdom | |||
| Hillingdon Hospitals NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11104556 | Background | Horwich A, Oliver RT, Wilkinson PM, Mead GM, Harland SJ, Cullen MH, Roberts JT, Fossa SD, Dearnaley DP, Lallemand E, Stenning SP; MRC Testicular Tumour Working Party. A medical research council randomized trial of single agent carboplatin versus etoposide and cisplatin for advanced metastatic seminoma. MRC Testicular Tumour Working Party. Br J Cancer. 2000 Dec;83(12):1623-9. doi: 10.1054/bjoc.2000.1498. | |
| 15266338 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carboplatin AUC-10 | Carboplatin area under the curve (AUC)-10: Carboplatin AUC-10 according to the Calvert formula [10 x (glomerular filtration rate (ml/min) + 25)]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Carboplatin AUC-10 | Carboplatin AUC-10: Carboplatin AUC-10 according to the Calvert formula [10 x (glomerular filtration rate (ml/min) + 25)]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 2 - Year Progression Free Survival | Number of participants progression free 2 years after registration. | All participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | 2 years |
|
|
Start of treatment until 30 days after last dose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Carboplatin AUC-10 | Carboplatin AUC-10: Carboplatin AUC-10 according to the Calvert formula [10 x (glomerular filtration rate (ml/min) + 25)]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Lead | Centre for Experimental Cancer Medicine, Barts Cancer Institute, QMUL | 02078828277 | bci-carpet@qmul.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2017 | Aug 9, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2018 | Aug 9, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018239 | Seminoma |
| ID | Term |
|---|---|
| D018237 | Germinoma |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 2 years |
| London |
| HA6 2RN |
| United Kingdom |
| Background |
| Bokemeyer C, Kollmannsberger C, Stenning S, Hartmann JT, Horwich A, Clemm C, Gerl A, Meisner C, Ruckerl CP, Schmoll HJ, Kanz L, Oliver T. Metastatic seminoma treated with either single agent carboplatin or cisplatin-based combination chemotherapy: a pooled analysis of two randomised trials. Br J Cancer. 2004 Aug 16;91(4):683-7. doi: 10.1038/sj.bjc.6602020. |
| 11345655 | Background | Shamash J, McLaren B, LeVay JH, Ong J, Murray P, Asterling S, Oliver RT. Carboplatin AUC8 in combination with etoposide and bleomycin in the treatment of intermediate and poor-risk metastatic germ cell tumours: a phase II study. Cancer Chemother Pharmacol. 2001 Apr;47(4):370-2. doi: 10.1007/s002800000217. |
| 9164194 | Background | Horwich A, Sleijfer DT, Fossa SD, Kaye SB, Oliver RT, Cullen MH, Mead GM, de Wit R, de Mulder PH, Dearnaley DP, Cook PA, Sylvester RJ, Stenning SP. Randomized trial of bleomycin, etoposide, and cisplatin compared with bleomycin, etoposide, and carboplatin in good-prognosis metastatic nonseminomatous germ cell cancer: a Multiinstitutional Medical Research Council/European Organization for Research and Treatment of Cancer Trial. J Clin Oncol. 1997 May;15(5):1844-52. doi: 10.1200/JCO.1997.15.5.1844. |
| 9667260 | Background | Gore M, Mainwaring P, A'Hern R, MacFarlane V, Slevin M, Harper P, Osborne R, Mansi J, Blake P, Wiltshaw E, Shepherd J. Randomized trial of dose-intensity with single-agent carboplatin in patients with epithelial ovarian cancer. London Gynaecological Oncology Group. J Clin Oncol. 1998 Jul;16(7):2426-34. doi: 10.1200/JCO.1998.16.7.2426. |
| 17242396 | Background | Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22. |
| 17242397 | Background | Juweid ME, Stroobants S, Hoekstra OS, Mottaghy FM, Dietlein M, Guermazi A, Wiseman GA, Kostakoglu L, Scheidhauer K, Buck A, Naumann R, Spaepen K, Hicks RJ, Weber WA, Reske SN, Schwaiger M, Schwartz LH, Zijlstra JM, Siegel BA, Cheson BD; Imaging Subcommittee of International Harmonization Project in Lymphoma. Use of positron emission tomography for response assessment of lymphoma: consensus of the Imaging Subcommittee of International Harmonization Project in Lymphoma. J Clin Oncol. 2007 Feb 10;25(5):571-8. doi: 10.1200/JCO.2006.08.2305. Epub 2007 Jan 22. |
| 11252008 | Background | A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001 Mar 30;20(6):859-66. doi: 10.1002/sim.721. |
| 7165009 | Background | Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available. |
| 31136925 | Derived | Shamash J, Syed R, Sarker SJ, Sarwar N, Sharma A, Mutsvangwa K, Coetzee C, Wilson P, Rustin GJ. A phase II study of carboplatin AUC-10 guided by positron emission tomography-defined metabolic response in metastatic seminoma. Eur J Cancer. 2019 Jul;115:128-135. doi: 10.1016/j.ejca.2019.04.013. Epub 2019 May 25. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Primary Tumour | Location of primary tumour. | Count of Participants | Participants |
|
| Sites of Metastases | Count of participants with metastases in specified locations. | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) | A quantification of participants daily living ability. 0. Fully active, able to carry out all normal activity without restriction.
| Count of Participants | Participants |
|
| Stage of Disease | Categories of stage 2 cancer: 2A - Cancer has spread to one or more lymph nodes, but no node is larger than 2 cm. 2B - Cancer has spread to at least one lymph node, which is between 2 cm and 5 cm in size. 2C - Cancer has spread to at least one lymph node that is larger than 5 cm. N/A - Mediastinal cancer | Count of Participants | Participants |
|
| Tumour Marker: Alpha-fetoprotein | Count of Participants | Participants |
|
| Tumour Marker: Beta-Human Chorionic Gonadotropin | Count of Participants | Participants |
|
| Tumour Marker: Lactate Dehydrogenase | Count of Participants | Participants |
|
| Glomerular Filtration Rate | Ethylenediaminetetraacetic acid (EDTA) clearance (43 participants) or estimated creatinine clearance determined by Cockcroft-Gault equation (5 participants). | Count of Participants | Participants |
|
|
|
| Secondary | Metabolic Response Rate | Number of participants achieving i) complete metabolic response (CR) and ii) partial metabolic response (PR) after one cycle of treatment. | All participants who completed one cycle of treatment and underwent PET-CT scan on day 17-21. | Posted | Count of Participants | Participants | 21 days |
|
|
|
|
| Secondary | Overall Survival | Survival status at 2 years after registration. | All participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | 2 years |
|
|
|
|
| 0 |
| 48 |
| 12 |
| 48 |
| 47 |
| 48 |
| Hypotension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Calculus bladder | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (18.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Neutropenic sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
No PI may present data from his/her centre separately from the rest of the study results unless approved by the Trial Steering Committee and the Sponsor.