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Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer

29 maart 2016 bijgewerkt door: Lorenzo Fuccio, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer: A Phase II Study.

Studie Overzicht

Toestand

Voltooid

Conditie

Rectale neoplasmata

Interventie / Behandeling

Gedetailleerde beschrijving

Neoadjuvant chemoradiation (CRT), is considered the standard treatment of locally advanced rectal cancer with a positive impact on locoregional control and survival. However, patients with T4 rectal cancer show high risk of local recurrence (LR) after conventional treatment. This was a prospective Phase II study on patients with locally advanced rectal cancer or locally recurrences, to evaluate the efficacy in terms of pathological response and resectability of concomitant boost RT (55 Gy/5 weeks) with concurrent Raltitrexed and Oxaliplatin (Tom-Ox) chemotherapy. The primary aim was to assess the pathological complete response rate. Key secondary aim was the resectability. Secondary aims were evaluation of treatment-related acute and late toxicity, local control, disease-free survival and overall survival (OS). The follow-up period of each subjects started after the radiochemotherapy treatment and ended after a maximum of 36 months of observation or until death.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

Fase

Fase 2

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

Histologically proven locally advanced (T4N0-2) or locally recurrent rectal adenocarcinoma;
Age ≥ 18 years;
Eastern Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion Criteria:

Metastatic patients
unfit surgery patients,
pregnant or breast feeding females
patients with clinically detectable ascites

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: NVT
Interventioneel model: Opdracht voor een enkele groep
Masker: Geen (open label)

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Experimenteel: Radiotherapy plus Tom-Ox Patients received concomitant boost RT (55 Gy/5 weeks) with concurrent Tom-Ox chemotherapy. The concurrent chemotherapy consisted of 15 min intravenous infusion Raltitrexed (Tomudex ®) 3 mg/m2 and a two-hours intravenous infusion of Oxaliplatin (Eloxatin ®) at 130 mg/m 2, 20 min after raltitrexed, on days 1, 17, 35.	Straling: Radiotherapy Radiotherapy was applied as conformal 3-D technique and was delivered with photon energies of 10 - 15 MV. The beams were delivered by an Elekta Precise Linac equipped with standard multi leaf collimators (MLC). A daily online check of isocenter position was performed using portal imaging, with set-up correction in case of displacement > 0.5 cm in any direction. Radiation dose delivered to PTV2 was 45 Gy (1.8 Gy/fraction) with a concomitant boost dose to the PTV1 of 10 Gy with accelerated fractionation at 2.2 Gy/fraction, five consecutive days for week. Geneesmiddel: Tom-OX The concurrent chemotherapy consisted of 15 min intravenous infusion Raltitrexed (Tomudex ®) 3 mg/m2 and a two-hours intravenous infusion of Oxaliplatin (Eloxatin ®) at 130 mg/m 2, 20 min after raltitrexed, on days 1, 17, 35. Andere namen: Tomudex ®, Eloxatin ®

Deelnemersgroep / Arm

Interventie / Behandeling

Experimenteel: Radiotherapy plus Tom-Ox

Patients received concomitant boost RT (55 Gy/5 weeks) with concurrent Tom-Ox chemotherapy. The concurrent chemotherapy consisted of 15 min intravenous infusion Raltitrexed (Tomudex ®) 3 mg/m2 and a two-hours intravenous infusion of Oxaliplatin (Eloxatin ®) at 130 mg/m 2, 20 min after raltitrexed, on days 1, 17, 35.

Straling: Radiotherapy

Radiotherapy was applied as conformal 3-D technique and was delivered with photon energies of 10 - 15 MV. The beams were delivered by an Elekta Precise Linac equipped with standard multi leaf collimators (MLC). A daily online check of isocenter position was performed using portal imaging, with set-up correction in case of displacement > 0.5 cm in any direction. Radiation dose delivered to PTV2 was 45 Gy (1.8 Gy/fraction) with a concomitant boost dose to the PTV1 of 10 Gy with accelerated fractionation at 2.2 Gy/fraction, five consecutive days for week.

Geneesmiddel: Tom-OX

The concurrent chemotherapy consisted of 15 min intravenous infusion Raltitrexed (Tomudex ®) 3 mg/m2 and a two-hours intravenous infusion of Oxaliplatin (Eloxatin ®) at 130 mg/m 2, 20 min after raltitrexed, on days 1, 17, 35.

Andere namen:

Tomudex ®, Eloxatin ®

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Number of patients defined as good responders (G1 or G2) according to the Mandard regression grading system. Tijdsspanne: 8 weeks after chemo-radiotherapy	Pathologic responses of the primary tumours were defined according to the Mandard regression grading system: grade 1 was recorded when no tumour cells remained in the primary tumour and lymph nodes (pCR); grade 2 was characterized by the presence of rare residual cancer cells scattered through the fibrosis; grade 3 was characterized by an increase in the number of residual cancer cells, but fibrosis still predominated; grade 4 showed residual cancer outgrowing fibrosis; and grade 5 was characterized by an absence of regressive changes. Good responders were defined those patients with a pathologic response with Mandard G1 or G2 and poor responder patients with Mandard G3, G4 or G5.	8 weeks after chemo-radiotherapy

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Number of patients in which a surgical resection was feasible Tijdsspanne: 8 weeks after chemo-radiotherapy		8 weeks after chemo-radiotherapy
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 Tijdsspanne: Up to 36 months. In details, follow-up examinations were performed 4 weeks after surgery and every 6 months until the established length of follow-up or death.	CTCAE v 3.0 was used to score acute and late radiation toxicity.	Up to 36 months. In details, follow-up examinations were performed 4 weeks after surgery and every 6 months until the established length of follow-up or death.
The number of patients without disease (i.e. rectal cancer) during the follow-up. Tijdsspanne: Up to 36 months.	The disease-free survival (DFS) was defined as the time from the diagnosis to the documented local or distant recurrence or last follow-up.	Up to 36 months.
The number of patients still alive at the end of follow-up Tijdsspanne: Up to 36 months	The overall-survival (OS) was defined as the time from the diagnosis until death for any cause or the last follow-up.	Up to 36 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Onderzoekers

Studie directeur: Alessio G Morganti, Prof, Division of Radiation Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2005

Primaire voltooiing (Werkelijk)

1 januari 2008

Studie voltooiing (Werkelijk)

1 februari 2012

Studieregistratiedata

Eerst ingediend

19 maart 2016

Eerst ingediend dat voldeed aan de QC-criteria

29 maart 2016

Eerst geplaatst (Schatting)

30 maart 2016

Updates van studierecords

Laatste update geplaatst (Schatting)

30 maart 2016

Laatste update ingediend die voldeed aan QC-criteria

29 maart 2016

Laatst geverifieerd

1 maart 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

TOMOX Rectal Study

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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