- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00749450
Combination Chemotherapy After Surgery in Treating Patients With High-Risk Stage II or Stage III Colorectal Cancer
Short Course Oncology Therapy - A Study of Adjuvant Chemotherapy in Colorectal Cancer
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which combination chemotherapy regimen is more effective in treating patients who have undergone surgery for high-risk colorectal cancer.
PURPOSE: This randomized phase III trial is studying chemotherapy given after surgery in treating patients with high-risk stage II or stage III colorectal cancer.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
- To assess the efficacy and compare the associated toxicity of adjuvant chemotherapy lasting 12 weeks vs 24 weeks in patients with fully resected high-risk stage II or III colorectal cancer.
- To conduct an economic analysis of the cost effectiveness of these regimens.
- To compare the randomization methodologies used in this study.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center's recruitment potential. Patients are randomized (within 10 weeks after surgery and before or after receiving 12 weeks of chemotherapy) to 1 of 2 treatment arms. The treatment regimen that a patient receives (Oxaliplatin Modified DeGramont [OxMdG] or XELOX) is determined by the participating center.
- Arm I: Patients receive 12 courses of OxMdG (described below) or XELOX (described below)combination chemotherapy (6 additional courses if patient already received 6 courses) for treatment lasting a total of 24 weeks.
- Arm II: Patients receive 6 courses of OxMdG or XELOX combination chemotherapy (no additional courses if patient already received 6 courses) for treatment lasting a total of 12 weeks.
The two adjuvant combination chemotherapy regimens are administered as follows:
- OxMdG: Patients receive oxaliplatin IV over 2 hours and fluorouracil IV continuously over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- XELOX: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality-of-life assessments periodically using the EORTC QLQ-C30, EORTC QLQ-CR29, EQ-5D, and GOG Ntx4 questionnaires.
After completion of study treatment, patients are followed periodically for up to 7 years.
Peer Reviewed and Funded by Medical Research Council (MRC)
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Scotland
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Glasgow, Scotland, Regno Unito, G12 0YN
- Beatson West of Scotland Cancer Centre
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
Diagnosis of colorectal cancer meeting 1 of the following criteria:
- High-risk stage IIB disease, defined as T4 disease, perforation, obstruction, < 10 nodes examined, poorly differentiated histology, extramural venous invasion, or extramural lymphatic invasion
- Fully resected stage III disease
Patients with rectal cancer must meet the following criteria:
- Underwent prior total mesorectal excision surgery with negative resection (R0) margins
- No prior pre-operative or scheduled post-operative combined chemotherapy and radiotherapy
- No evidence of residual or metastatic disease
- Deemed suitable for adjuvant chemotherapy
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Life expectancy > 5 years with reference to noncancer-related diseases
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- AST and ALT ≤ 2.5 times upper limit of normal
- Carcinoembryonic antigen (CEA) levels normal
- Glomerular filtration rate ≥ 30 mL/min (no moderate or severe renal impairment)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must effective contraception
More than 12 months since prior and no active clinically significant cardiovascular disease, including any of the following:
- Cerebrovascular accident
- Myocardial infarction
- Unstable angina
- New York Heart Association class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg)
- Disease-free interval of ≥ 5 years for previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal cell or squamous cell carcinoma of the skin
- No known or suspected dihydropyrimidine dehydrogenase deficiency
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 10 weeks since prior surgery and recovered
- No prior chemotherapy (except in patients randomized after 12 weeks of adjuvant therapy)
- No prior abdomino-pelvic radiotherapy, with the exception of short-course pre-operative radiotherapy for rectal cancer
- No concurrent brivudine or sorivudine for patients taking capecitabine
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Arm I
Patients receive OxMdG or XELOX combination chemotherapy for a total of 12 courses for treatment lasting a total of 24 weeks.
|
Dato IV
Dato IV
Dato oralmente
|
Sperimentale: Arm II
Patients receive OxMdG or XELOX combination chemotherapy for a total of 6 courses for treatment lasting a total of 12 weeks.
|
Dato IV
Dato IV
Dato oralmente
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Sopravvivenza libera da malattia a 3 anni
Lasso di tempo: 3 anni
|
3 anni
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Overall survival
Lasso di tempo: assessed during 5 year recruitment period and maximum 7 year follow up period
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assessed during 5 year recruitment period and maximum 7 year follow up period
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Cost-effectiveness
Lasso di tempo: assessed during 5 year recruitment period
|
assessed during 5 year recruitment period
|
Toxicity according to NCI CTCAE Version 3.0
Lasso di tempo: assessed during 5 year recruitment period
|
assessed during 5 year recruitment period
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Quality of life as assessed by EORTC QLQ-C30, EORTC QLQ-CR29, EQ-5D, and GOG Ntx4
Lasso di tempo: assessed during 5 year recruitment period
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assessed during 5 year recruitment period
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Tim Iveson, FRCP, MD, MRCP, MBBS, BSC, University Hospital Southampton NHS Foundation Trust
Pubblicazioni e link utili
Pubblicazioni generali
- Iveson TJ, Sobrero AF, Yoshino T, Souglakos I, Ou FS, Meyers JP, Shi Q, Grothey A, Saunders MP, Labianca R, Yamanaka T, Boukovinas I, Hollander NH, Galli F, Yamazaki K, Georgoulias V, Kerr R, Oki E, Lonardi S, Harkin A, Rosati G, Paul J. Duration of Adjuvant Doublet Chemotherapy (3 or 6 months) in Patients With High-Risk Stage II Colorectal Cancer. J Clin Oncol. 2021 Feb 20;39(6):631-641. doi: 10.1200/JCO.20.01330. Epub 2021 Jan 13. Erratum In: J Clin Oncol. 2021 May 20;39(15):1691.
- Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Neoplasie
- Neoplasie per sede
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie gastrointestinali
- Malattie del colon
- Malattie intestinali
- Neoplasie intestinali
- Malattie del retto
- Neoplasie colorettali
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Fluorouracile
- Capecitabina
- Oxaliplatino
Altri numeri di identificazione dello studio
- CDR0000613042
- CRUK-SCOT
- ISRCTN59757862
- EudraCT 2007-003957-10
- EU-20874
- SCOT-2007-01
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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