Fraktioneret strålebehandling til behandling af avanceret planocellulært karcinom i hoved og hals
Fase III randomiseret sammenligning af strålebehandlingsfraktionering i avanceret planocellulært karcinom i hoved og hals: Hyperfraktionering to gange dagligt vs split-kursus accelereret hyperfraktionering vs accelereret fraktionering med samtidig boost vs standardfraktionering
RATIONALE: Patientresumé ikke tilgængelig
FORMÅL: Patientresumé ikke tilgængelig
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
MÅL: I. Bestem, om hyperfraktionering og/eller accelereret fraktionering (split-kursus eller med et samtidig boost) forbedrer den lokoregionale kontrolrate i forhold til standardfraktioneringsstrålebehandling hos patienter med fremskredne pladecellekarcinomer i hoved og hals. II. Bestem den sygdomsfrie overlevelse og den samlede overlevelse for disse patienter behandlet med forskellige strålebehandlingsfraktioneringsskemaer. III. Bestem de akutte og sene toksiciteter for hvert fraktioneringsskema. IV. Sammenlign livskvaliteten på de to kure.
OVERSIGT: Randomiseret undersøgelse. Arm I: Strålebehandling. Bestråling af primær tumor og involverede og udsatte knudeområder ved hjælp af lineære acceleratorer med fotonenergier på 1,25-6,0 MV (dobbeltenergiarrangementer kan også bruge en stråle større end 6,0 MV), elektroner på 4-25 MV eller Co60. Standard fraktionering. Arm II: Strålebehandling. Mål og udstyr som i Arm I. Hyperfraktionering. Arm III: Strålebehandling. Mål og udstyr som i Arm I. Accelereret split-kurs hyperfraktionering. Arm IV: Strålebehandling. Mål og udstyr som i Arm I. Accelereret fraktionering med samtidig boost.
PROJEKTERET OPSLAG: I alt 1.080 patienter (270/arm) vil blive optjent over 5,75 år. Hvis der observeres overdreven toksicitet i en arm efter indtræden af 324 og 634 patienter, kan den arm lukkes.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
SYGDOMSKARAKTERISTIKA: Histologisk påvist planocellulært karcinom i hoved og hals, inklusive lymfepitheliom og anaplastisk karcinom Biopsi fra de primære eller regionale knuder acceptabel Ingen adenokarcinomer Følgende stadier og steder er kvalificerede: Stadie III/IV mundhule 2/3, inklusiv: af tungen Buccal slimhinde Mundbund Hård gane Gingiva Retromolar trigon Stadium III/IV oropharynx, inklusive: Tonsil og søjler Faucialbue og blød gane Posterolaterale svælgvægge Stadium II/III/IV tungebund og hypopharynx Stadium III/IV supraglottisk , herunder: Ventrikulært bånd Arytenoid Supra- og infrahyoid epiglottis Aryepiglottisk fold (tumorer på glottiske og subglottiske steder udelukket) Ikke-palpable noder, der kun påvises på CT eller MR, skal være mindst 1,0 cm i diameter eller indeholde nekrose for at påvise N+ sygdom. Ingen metastaser under nøglebenet klinisk eller radiologisk
PATIENTKARAKTERISTIKA: Alder: Mindst 18 Ydeevnestatus: Karnofsky 60-100% Hæmatopoietisk: Ikke specificeret Lever: Ikke specificeret Nyre: Ikke specificeret Andet: Medicinsk i stand til at modstå strålebehandling Ingen anden malignitet inden for 5 år undtagen ikke-melanomatøs hudkræft Opfølgning ved deltagelse stråleterapeut påkrævet
FORUDGÅENDE SAMTYDLIG BEHANDLING: Biologisk terapi: Ikke specificeret Kemoterapi: Ingen forudgående kemoterapi Endokrin terapi: Ikke specificeret Strålebehandling: Ingen forudgående strålebehandling til hoved og nakke Ingen planlagt kombineret ekstern stråle og interstitiel boost-bestråling Kirurgi: Ingen forudgående operation (bortset fra biopsi) Ingen planlagt kombineret præ- eller postoperative programmer Radikale nakkedissektioner tilladt, hvis lymfeknuder er større end 3 cm før strålebehandling eller involvering fortsætter efter behandling Resektion af vedvarende sygdom på det primære sted kan udføres 6 uger efter afslutning af strålebehandling
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: BEHANDLING
- Tildeling: TILFÆLDIGT
- Interventionel model: PARALLEL
- Maskning: INGEN
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
ACTIVE_COMPARATOR: Standardfraktionering
Standardfraktionering: 2 Gy/Fx, Q.D. 5 dage/uge, samlet dosis: 70 Gy/35 Fx x 7 uger
|
|
|
EKSPERIMENTEL: Hyperfraktionering
Hyperfraktionering: 1,2 Gy/Fx, b.i.d.
(> 6 timers mellemrum, 5 dage/uge) Samlet dosis: 81,6 Gy/68 Fx/7 uger
|
|
|
EKSPERIMENTEL: Accelereret hyperfraktionering med split
Accelereret hyperfraktionering med split: 1,6 Gy/Fx b.i.d.
(> 6 timers mellemrum), 5 dage/uge, total dosis: 67,2 Gy/42 Fx/6 uger med 2 ugers hvile efter 38,4 Gy
|
|
|
EKSPERIMENTEL: Accelereret fraktionering med samtidig boost
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- Gillison ML, Zhang Q, Jordan R, Xiao W, Westra WH, Trotti A, Spencer S, Harris J, Chung CH, Ang KK. Tobacco smoking and increased risk of death and progression for patients with p16-positive and p16-negative oropharyngeal cancer. J Clin Oncol. 2012 Jun 10;30(17):2102-11. doi: 10.1200/JCO.2011.38.4099. Epub 2012 May 7.
- Dilling TJ, Bae K, Paulus R, Watkins-Bruner D, Garden AS, Forastiere A, Kian Ang K, Movsas B. Impact of gender, partner status, and race on locoregional failure and overall survival in head and neck cancer patients in three radiation therapy oncology group trials. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):e101-9. doi: 10.1016/j.ijrobp.2011.01.013. Epub 2011 May 5.
- Spiegel D, Kraemer HC. Emotional well-being does not predict survival in head and neck cancer patients: a Radiation Therapy Oncology Group study. Cancer. 2008 May 15;112(10):2326-7; author reply 2327-8. doi: 10.1002/cncr.23435. No abstract available.
- Schumaker L, Nikitakis N, Goloubeva O, Tan M, Taylor R, Cullen KJ. Elevated expression of glutathione S-transferase pi and p53 confers poor prognosis in head and neck cancer patients treated with chemoradiotherapy but not radiotherapy alone. Clin Cancer Res. 2008 Sep 15;14(18):5877-83. doi: 10.1158/1078-0432.CCR-08-0998.
- Siddiqui F, Pajak TF, Watkins-Bruner D, Konski AA, Coyne JC, Gwede CK, Garden AS, Spencer SA, Jones C, Movsas B. Pretreatment quality of life predicts for locoregional control in head and neck cancer patients: a radiation therapy oncology group analysis. Int J Radiat Oncol Biol Phys. 2008 Feb 1;70(2):353-60. doi: 10.1016/j.ijrobp.2007.06.024. Epub 2007 Sep 24.
- Coyne JC, Pajak TF, Harris J, Konski A, Movsas B, Ang K, Watkins Bruner D; Radiation Therapy Oncology Group. Emotional well-being does not predict survival in head and neck cancer patients: a Radiation Therapy Oncology Group study. Cancer. 2007 Dec 1;110(11):2568-75. doi: 10.1002/cncr.23080.
- Sanabria A, Carvalho AL, Kowalski LP. Is nutrition support related to a poor prognosis in head and neck cancer patients? Thoughts about the secondary analysis of RTOG trial 90-03. Head Neck. 2007 May;29(5):518-9; author reply 519-20. doi: 10.1002/hed.20617. No abstract available.
- Konski AA, Pajak T, Movsas B, et al.: Socio-demographic variables influence outcome in Radiation Therapy Oncology Group head and neck trials. [Abstract] Proceedings of the American Society of Clinical Oncology 22 (Suppl 14): A-6043, 529s, 2004.
- Kumar P, Harris J, Garden AS, et al.: Outcome comparisons of four Radiation Therapy Oncology Group (RTOG) trials in patients with stage IV-T4 head and neck (H/N) cancer: encouraging results using intra-arterial (IA) cisplatin (P) and concurrent radiation therapy (RT). [Abstract] J Clin Oncol 22 (Suppl 14): A-5527, 494s, 2004.
- Movsas B, Konski A, Pajak T, et al.: Quality of life (QOL) variables influence local regional control in Radiation Therapy Oncology Group (RTOG) headsneck trials (9003 and 9111). [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-199, S252, 2004.
- Owen JB, Grigsby PW, Caldwell TM, Konski AA, Johnson DJ, Demas WF, Movsas B, Jones CU, Wasserman TH. Can costs be measured and predicted by modeling within a cooperative clinical trials group? Economic methodologic pilot studies of the radiation therapy oncology group (RTOG) studies 90-03 and 91-04. Int J Radiat Oncol Biol Phys. 2001 Mar 1;49(3):633-9. doi: 10.1016/s0360-3016(00)00770-7.
- Chung CH, Dignam JJ, Hammond ME, Klimowicz AC, Petrillo SK, Magliocco A, Jordan R, Trotti A, Spencer S, Cooper JS, Le QT, Ang KK. Glioma-associated oncogene family zinc finger 1 expression and metastasis in patients with head and neck squamous cell carcinoma treated with radiation therapy (RTOG 9003). J Clin Oncol. 2011 Apr 1;29(10):1326-34. doi: 10.1200/JCO.2010.32.3295. Epub 2011 Feb 28.
- Chung CH, Dignam J, Hammond ME, et al.: Association of high Gli1 expression with poor survival in head and neck cancer patients treated with radiation therapy (RTOG 9003). [Abstract] J Clin Oncol 28 (Suppl 15): A-5552, 2010.
- Konski AA, Winter K, Cole BF, Ang KK, Fu KK. Quality-adjusted survival analysis of Radiation Therapy Oncology Group (RTOG) 90-03: phase III randomized study comparing altered fractionation to standard fractionation radiotherapy for locally advanced head and neck squamous cell carcinoma. Head Neck. 2009 Feb;31(2):207-12. doi: 10.1002/hed.20949.
- Le QT, Harris J, Magliocco AM, Kong CS, Diaz R, Shin B, Cao H, Trotti A, Erler JT, Chung CH, Dicker A, Pajak TF, Giaccia AJ, Ang KK. Validation of lysyl oxidase as a prognostic marker for metastasis and survival in head and neck squamous cell carcinoma: Radiation Therapy Oncology Group trial 90-03. J Clin Oncol. 2009 Sep 10;27(26):4281-6. doi: 10.1200/JCO.2008.20.6003. Epub 2009 Aug 10.
- Calvin DP, Hammond ME, Pajak TF, Trotti AM, Meredith RF, Rotman M, Jones CU, Byhardt RW, Demas WF, Ang KK, Fu KK; Radiation Therapy Oncology Group 90-03 Trial. Microvessel density >or=60 does not predict for outcome after radiation treatment for locally advanced head and neck squamous cell carcinoma: results of a correlative study from the Radiation Therapy Oncology Group (RTOG) 90-03 Trial. Am J Clin Oncol. 2007 Aug;30(4):406-19. doi: 10.1097/COC.0b013e3180342fd4.
- Konski AA, Bhargavan M, Owen J, et al.: Altered fractionated radiotherapy is cost-effective in the treatment of locally advanced head and neck cancer: an economic analysis of Radiation Therapy Oncology Group (RTOG) 90-03. [Abstract] J Clin Oncol 24 (Suppl 18): A-6007, 302s, 2006.
- Rabinovitch R, Grant B, Berkey BA, Raben D, Ang KK, Fu KK, Cooper JS; Radiation Therapy Oncology Group. Impact of nutrition support on treatment outcome in patients with locally advanced head and neck squamous cell cancer treated with definitive radiotherapy: a secondary analysis of RTOG trial 90-03. Head Neck. 2006 Apr;28(4):287-96. doi: 10.1002/hed.20335.
- Pajak TF, Trotti A, Gwede CK, et al.: The TAME risk classification system: acute toxicity burden and IPD analysis of RTOG 90-03. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-217, S131, 2005.
- Fu KK, Pajak TF, Trotti A, Jones CU, Spencer SA, Phillips TL, Garden AS, Ridge JA, Cooper JS, Ang KK. A Radiation Therapy Oncology Group (RTOG) phase III randomized study to compare hyperfractionation and two variants of accelerated fractionation to standard fractionation radiotherapy for head and neck squamous cell carcinomas: first report of RTOG 9003. Int J Radiat Oncol Biol Phys. 2000 Aug 1;48(1):7-16. doi: 10.1016/s0360-3016(00)00663-5.
- Hammond E, Berkey BA, Fu KK, Trotti A, Meredith RF, Jones CU, Byhardt R, Horwitz EM, Ang KK. P105 as a prognostic indicator in patients irradiated for locally advanced head-and-neck cancer: a clinical/laboratory correlative analysis of RTOG-9003. Int J Radiat Oncol Biol Phys. 2003 Nov 1;57(3):683-92. doi: 10.1016/s0360-3016(03)00642-4.
- Konski A, Berkey BA, Kian Ang K, Fu KK. Effect of education level on outcome of patients treated on Radiation Therapy Oncology Group Protocol 90-03. Cancer. 2003 Oct 1;98(7):1497-503. doi: 10.1002/cncr.11661.
- Tu X, Berkey BA, Zhang HZ, et al.: Impact of EGFR expression on the response of advanced head and neck carcinomas to concomitant boost radiotherapy in a RTOG phase III trial (90-03). Int J Radiat Oncol Biol Phys 57 (2 Suppl): S157, 2003.
- Ang KK, Berkey BA, Tu X, Zhang HZ, Katz R, Hammond EH, Fu KK, Milas L. Impact of epidermal growth factor receptor expression on survival and pattern of relapse in patients with advanced head and neck carcinoma. Cancer Res. 2002 Dec 15;62(24):7350-6.
- Eldridge B, Rabinovitch R, Berkey BA, et al.: The impact of baseline nutritional support on treatment outcome in patients with locally advanced squamous cell cancer of the head and neck treated with definitive radiotherapy: report of the Radiation Therapy Oncology Group (RTOG) trial 90-03. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): A-199, 115, 2002.
- Konski A, Berkey B, Ang KK, et al.: The effect of education level on outcome of patients treated on Radiation Therapy Oncology Group (RTOG) protocol 90-03. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-992, 2002.
- Calvin DP, Hammond ME, Pajak TF, et al.: Microvessel density (MVD)> 60 does not predict for outcome in advanced head and neck squamous cell carcinoma (HNSCC): results of a prospective study from the RTOG 90-03 trial. [Abstract] Int J Radiat Oncol Biol Phys 51 (3 suppl 1): A-68, 41, 2001.
- Fisher J, Scott C, Fu K, et al.: Treatment, patient and tumor characteristics impact quality of life (QOL) in patients with locally advanced head and neck cancer: report of the Radiation Therapy Oncology Group (RTOG) trial 90-03. [Abstract] Int J Radiat Oncol Biol Phys 51 (3 suppl 1): A-174, 98, 2001.
- Konski AA, Scott CB, Ang KK, et al.: Does dose escalation of radiotherapy (RT) improve quality-adjusted survival (QAS) in unresectable head and neck cancer (HNC) patients (Pts)? Radiation Therapy Oncology Group (RTOG) study 90-03. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-906, 227a, 2001.
- Konski A, Scott C, Ang KK, et al.: Cost-utility analysis of RTOG 90-03: phase III randomized study comparing altered fractionation to standard fractionation radiotherapy for locally advanced head and neck squamous cell carcinoma. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-87, 48, 2001.
- Fisher J, Scott C, Fu K, et al.: Randomized study comparing quality of life between standard fractionation radiotherapy and altered fractionation schemas in patients with locally advanced squamous cell cancer of the head and neck. [Abstract] Proceedings of the International Conference on Head and Neck Cancer A201, 117, 2000.
- Mell LK, Shen H, Nguyen-Tan PF, Rosenthal DI, Zakeri K, Vitzthum LK, Frank SJ, Schiff PB, Trotti AM 3rd, Bonner JA, Jones CU, Yom SS, Thorstad WL, Wong SJ, Shenouda G, Ridge JA, Zhang QE, Le QT. Nomogram to Predict the Benefit of Intensive Treatment for Locoregionally Advanced Head and Neck Cancer. Clin Cancer Res. 2019 Dec 1;25(23):7078-7088. doi: 10.1158/1078-0432.CCR-19-1832. Epub 2019 Aug 16.
Datoer for undersøgelser
Studer store datoer
Primær færdiggørelse (FAKTISKE)
Studieafslutning (FAKTISKE)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (SKØN)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (SKØN)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- stadium III planocellulært karcinom i læben og mundhulen
- stadium IV planocellulært karcinom i læben og mundhulen
- stadium III planocellulært karcinom i oropharynx
- stadium III lymfepitheliom i oropharynx
- stadium IV planocellulært karcinom i oropharynx
- stadium IV lymfepitheliom i oropharynx
- stadium III planocellulært karcinom i hypopharynx
- stadium IV planocellulært karcinom i hypopharynx
- stadium III planocellulært karcinom i strubehovedet
- stadium IV planocellulært karcinom i strubehovedet
- fase II planocellulært karcinom i hypopharynx
- fase II planocellulært karcinom i oropharynx
- stadium II lymfepitheliom i oropharynx
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RTOG-9003
- CDR0000076475
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .