- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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)
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Scotland
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Glasgow, Scotland, Storbritannia, G12 0YN
- Beatson West of Scotland Cancer Centre
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Arm I
Patients receive OxMdG or XELOX combination chemotherapy for a total of 12 courses for treatment lasting a total of 24 weeks.
|
Gitt IV
Gitt IV
Gis muntlig
|
Eksperimentell: Arm II
Patients receive OxMdG or XELOX combination chemotherapy for a total of 6 courses for treatment lasting a total of 12 weeks.
|
Gitt IV
Gitt IV
Gis muntlig
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
3 års sykdomsfri overlevelse
Tidsramme: 3 år
|
3 år
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Overall survival
Tidsramme: 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
Tidsramme: assessed during 5 year recruitment period
|
assessed during 5 year recruitment period
|
Toxicity according to NCI CTCAE Version 3.0
Tidsramme: assessed during 5 year recruitment period
|
assessed during 5 year recruitment period
|
Quality of life as assessed by EORTC QLQ-C30, EORTC QLQ-CR29, EQ-5D, and GOG Ntx4
Tidsramme: assessed during 5 year recruitment period
|
assessed during 5 year recruitment period
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Tim Iveson, FRCP, MD, MRCP, MBBS, BSC, University Hospital Southampton Nhs Foundation Trust
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer
- Neoplasmer etter nettsted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Kolonsykdommer
- Tarmsykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Kolorektale neoplasmer
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Fluorouracil
- Capecitabin
- Oksaliplatin
Andre studie-ID-numre
- CDR0000613042
- CRUK-SCOT
- ISRCTN59757862
- EudraCT 2007-003957-10
- EU-20874
- SCOT-2007-01
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