- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00002839
Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx
PHASE II STUDY ON LARYNX PRESERVATION COMPARING INDUCTION CHEMOTHERAPY AND RADIOTHERAPY VERSUS ALTERNATING CHEMO-RADIOTHERAPY IN RESECTABLE HYPOPHARYNX AND LARYNX CANCERS
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to preserve the part of the body where the cancer started. It is not yet known which regimen of cisplatin and fluorouracil combined with radiation therapy is more effective in treating resectable cancer of the hypopharynx or larynx.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of cisplatin and fluorouracil combined with radiation therapy in preserving the larynx in patients who have resectable cancer of the hypopharynx or larynx.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
OBJECTIVES:
- Compare relapse-free survival and larynx preservation in patients with resectable hypopharyngeal or laryngeal cancer treated with sequential vs alternating cisplatin and fluorouracil and radiotherapy.
- Compare the health-related quality of life in patients treated with these regimens.
- Compare the cost-effectiveness of these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by performance status, disease site, tumor stage, node stage, and center.
Patients are randomized to one of two treatment arms. Both groups may receive either conventional radiotherapy in single daily fractions, 5 days per week, for 7 weeks (option 1) or hyperfractionated radiotherapy in 2 daily fractions, 5 days per week, for 4-5 weeks (option 2), according to institutional policy.
- Arm I: Patients receive cisplatin and fluorouracil every 3 weeks. Patients with a complete or partial response on day 42 receive 2 additional courses of chemotherapy followed by 7 weeks of radiotherapy beginning on day 80. After radiotherapy, patients with a complete remission enter follow-up; those with a partial remission proceed to surgery. Patients with stable or progressive disease proceed immediately to surgery with or without postoperative radiotherapy.
- Arm II: Patients receive cisplatin and fluorouracil every 3 weeks for 4 courses. Patients treated on radiotherapy option 1 are evaluated 2 months after completion of radiotherapy; those with a complete remission enter follow-up while all others proceed to surgery. Patients treated on option 2 are evaluated on day 42; those with a partial or complete response complete chemoradiotherapy and are then evaluated and treated like option 1 patients. Patients with stable or progressive disease on day 42 proceed to surgery with or without a third course of chemotherapy on week 7.
Patients are followed every 3 months for 3 years and at least every 6 months thereafter.
PROJECTED ACCRUAL: A total of 564 patients will be accrued for this study within 4 years.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Antwerp, Belgio, 2020
- Algemeen Ziekenhuis Middelheim
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Edegem, Belgio, B-2650
- Universitair Ziekenhuis Antwerpen
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Besancon, Francia, 25030
- CHR de Besancon - Hopital Jean Minjoz
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Caen, Francia, 14076
- Centre Regional Francois Baclesse
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Dijon, Francia, 21033
- Centre Hospitalier Universitaire De Dijon
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Dijon, Francia, 21079
- Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
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Lille, Francia, 59020
- Centre Oscar Lambret
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Lille, Francia, 59037
- Centre Hospitalier Regional et Universitaire de Lille
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Nantes-Saint Herblain, Francia, 44805
- CRLCC Nantes - Atlantique
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Nice, Francia, 06189
- Centre Antoine Lacassagne
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Rouen, Francia, 76031
- Hopital Charles Nicolle
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Vandoeuvre-les-Nancy, Francia, 54511
- Centre Alexis Vautrin
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Haifa, Israele, 31096
- Rambam Medical Center
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Milano (Milan), Italia, 20133
- Istituto Nazionale Per Lo Studio E La Cura Dei Tumori
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Monselice, Padova, Italia, 35043
- Ospedale Civile Monselice
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Pordenone, Italia, 33170
- Azienda Ospedaliera "Santa Maria Degli Angeli"
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Amsterdam, Olanda, 1007 MB
- Vrije Universiteit Medisch Centrum
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Leiden, Olanda, 2300 CA
- Leiden University Medical Center
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Maastricht, Olanda, 6202 AZ
- Academisch Ziekenhuis Maastricht
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Lausanne, Svizzera, CH-1011
- Centre Hospitalier Universitaire Vaudois
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
Histologically proven squamous cell carcinoma of the head and neck, including:
Stage III/IV cancer of the glottic or supraglottic larynx
Eligible T4 tumor defined as:
- Bulging the valleculae
- Bulging the hyothyroid membrane
- Minimal thyroid cartilage invasion or suspicion of invasion on imaging
Stage II/III/IV cancer of the pyriform sinus or of the hypopharyngeal aspect of the aryepiglottic fold (with or without extension to postcricoid area)
- No massive destruction of the thyroid cartilage
- No continuity between primary tumor and a lymph node
Operable on first attempt (as assessed by head and neck surgeon) by classical total laryngectomy with or without partial pharyngectomy
- No requirement for extended surgery (circumferential pharyngolaryngectomy)
- No tumor suitable for partial (functional) surgery or requiring extended surgery that necessitates any kind of flap for closure
- No N2c tumor unless no requirement for bilateral resection of internal jugular veins
Measurable or evaluable disease by panendoscopy and CT scan or MRI
- Esophagoscopy required
- Bronchofiberscopy recommended
- No requirement for tracheotomy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2 OR
- WHO 0-2
Hematopoietic:
- WBC at least 4,000/mm^3
Hepatic:
- Bilirubin no greater than 2.0 times normal
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Other:
- No medical, psychological, or geographical condition that precludes study compliance
- No serious nonmalignant systemic disease
No second malignancy except:
- Carcinoma in situ of the cervix
- Adequately treated nonmelanomatous skin cancer
- No poor nutritional status unlikely to be restored to fair status within 3 weeks
- No contraindication to CT scan or general anesthesia
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior anticancer biologic therapy
Chemotherapy
- No prior anticancer chemotherapy
Endocrine therapy
- No prior anticancer endocrine therapy
Radiotherapy
- No prior anticancer radiotherapy
Surgery
- See Disease Characteristics
Other
- No other prior anticancer therapy
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
Collaboratori e investigatori
Investigatori
- Cattedra di studio: Jean-Louis Lefebvre, MD, Centre Oscar Lambret
- Cattedra di studio: Jean-Claude Horiot, MD, PhD, Centre Georges François Leclerc
Pubblicazioni e link utili
Pubblicazioni generali
- Lefebvre JL, Rolland F, Tesselaar M, Bardet E, Leemans CR, Geoffrois L, Hupperets P, Barzan L, de Raucourt D, Chevalier D, Licitra L, Lunghi F, Stupp R, Lacombe D, Bogaerts J, Horiot JC, Bernier J, Vermorken JB; EORTC Head and Neck Cancer Cooperative Group; EORTC Radiation Oncology Group. Phase 3 randomized trial on larynx preservation comparing sequential vs alternating chemotherapy and radiotherapy. J Natl Cancer Inst. 2009 Feb 4;101(3):142-52. doi: 10.1093/jnci/djn460. Epub 2009 Jan 27.
- Lefebvre J, Horiot J, Rolland F, et al.: Phase III study on larynx preservation comparing induction chemotherapy and radiotherapy versus alternating chemoradiotherapy in resectable hypopharynx and larynx cancers. EORTC protocol 24954-22950. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA6016, 303s, 2007.
- Bottomley A, Tridello G, Coens C, Rolland F, Tesselaar ME, Leemans CR, Hupperets P, Licitra L, Vermorken JB, Van Den Weyngaert D, Truc G, Barillot I, Lefebvre JL. An international phase 3 trial in head and neck cancer: quality of life and symptom results: EORTC 24954 on behalf of the EORTC Head and Neck and the EORTC Radiation Oncology Group. Cancer. 2014 Feb 1;120(3):390-8. doi: 10.1002/cncr.28392. Epub 2013 Oct 25.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio
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 delle vie respiratorie
- Malattie otorinolaringoiatriche
- Malattie laringee
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Cisplatino
- Fluorouracile
Altri numeri di identificazione dello studio
- EORTC-24954
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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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