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A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer (INOVA)

31 luglio 2017 aggiornato da: Hoffmann-La Roche

Efficacy and Safety of Two Neoadjuvant Strategies With Bevacizumab in Locally Advanced Resectable Rectal Cancer: A Randomized, Non-Comparative Phase II Study

This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

91

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • Angers, Francia, 49055
        • ICO Paul Papin; Oncologie Medicale.
      • Angers, Francia, 49055
      • Besancon, Francia, 25030
      • Besancon, Francia, 25030
        • HOPITAL JEAN MINJOZ; Oncologie
      • Bordeaux, Francia, 33075
      • Bordeaux, Francia, 33075
        • Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale
      • Dijon, Francia, 21079
        • Centre Georges Francois Leclerc; Oncologie 3
      • Dijon, Francia, 21079
      • La Tronche, Francia, 38700
      • La Tronche, Francia, 38700
        • Hopital Albert Michallon; Radiotherapie
      • Lille, Francia, 59020
      • Lille, Francia, 59020
        • Centre Oscar Lambret; Radiotherapie
      • Montbeliard, Francia, 25209
      • Montbeliard, Francia, 25209
        • Centre Hospitalier Andre Boulloche; Departement D'Oncologie
      • Montpellier, Francia, 34928
      • Montpellier, Francia, 34928
        • Centre Val Aurelle Paul Lamarque; Radiotherapie
      • Nancy, Francia, 54100
      • Nancy, Francia, 54100
        • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
      • Nice, Francia, 06189
        • Centre Antoine Lacassagne; Hopital De Jour A2
      • Nice, Francia, 06189
      • Paris, Francia, 75970
        • HOPITAL TENON; Cancerologie Medicale
      • Paris, Francia, 75970
      • Paris, Francia, 75651
      • Paris, Francia, 75475
      • Paris, Francia, 75651
        • Ch Pitie Salpetriere; Oncologie Medicale
      • Paris, Francia, 75475
        • Hopital Saint Louis; Radiotherapie Oncologie
      • Pierre Benite, Francia, 69495
      • Pierre Benite, Francia, 69495
        • Ch Lyon Sud; Radiotherapie Sct Jules Courmont
      • Poitiers, Francia, 86021
      • Poitiers, Francia, 86021
        • Chu La Miletrie; Radiotherapie
      • Saint Herblain, Francia, 44805
        • Ico Rene Gauducheau; Oncologie
      • Saint Herblain, Francia, 44805
      • Strasbourg, Francia, 67065
        • Centre Paul Strauss; Oncologie Medicale
      • Strasbourg, Francia, 67065
      • Toulouse, Francia, 31078
      • Toulouse, Francia, 31078
        • Polyclinique Du Parc; Centre De Hautes Energies
      • Tours, Francia, 37044
      • Tours, Francia, 37044
        • Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie
      • Vandoeuvre Les Nancy, Francia, 54511
      • Vandoeuvre Les Nancy, Francia, 54511
        • Centre Alexis Vautrin; Oncologie Medicale

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • histologically confirmed locally advanced rectal cancer;
  • measurable disease;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Exclusion Criteria:

  • prior treatment with bevacizumab;
  • prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;
  • previous history of malignancy (other than basal and squamous cell cancer of the skin, or in situ cancer of the cervix);
  • history or evidence of central nervous system (CNS) disease;
  • clinically significant cardiovascular disease;
  • chronic treatment with high dose aspirin (more than [>] 325 milligrams per day [mg/day]) or non-steroidal anti-inflammatory drugs.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

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 A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)
In this arm, participants will undergo 3 phases of treatment. During the Phase 1, participants will receive induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (intravenous [IV] infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 will be surgery involving a radical rectal excision using the total mesorectal excision (TME) technique.
Droga: Bevacizumab
Bevacizumab will be administered at the fixed dose of 5 milligrams per kilogram (mg/kg) as an IV infusion over 30 to 90 minutes.
Altri nomi:
  • Avastin
Droga: Oxaliplatin
Oxaliplatin will be administered at a dose of 85 milligrams per square meter (mg/m^2) as a 2-hour IV infusion.
Droga: Folinic Acid
Folinic acid will be administered at a dose of 200 mg/m^2 as a 2-hour infusion.
Droga: 5-fluorouracil
5-fluorouracil will be administered at a dose of 400 mg/m^2 as an IV bolus, then at a dose of 600 mg/m^2 as a continuous infusion for 22 hours in Phase 1, and will be administered at a dose of 225 mg/m^2 as a 24-hour infusion, 5 days a week, for 5 weeks in Phase 2.
Radiazione: Preoperative Radiotherapy
Radiotherapy will be delivered in fraction of 1.8 gray per day (Gy/day), 5 days a week for 5 weeks, i.e., a total dose of 45 Gy will be administered in 25 fractions over a period of 33 days.
Procedura: Surgery
Radical rectal excision based on the TME technique.
Sperimentale: Arm B (Bevacizumab, Chemoradiotherapy)
In this arm, participants will receive the Phase 2 and Phase 3 treatments only. The phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 will be surgery involving a radical rectal excision using the TME technique.
Droga: Bevacizumab
Bevacizumab will be administered at the fixed dose of 5 milligrams per kilogram (mg/kg) as an IV infusion over 30 to 90 minutes.
Altri nomi:
  • Avastin
Droga: 5-fluorouracil
5-fluorouracil will be administered at a dose of 400 mg/m^2 as an IV bolus, then at a dose of 600 mg/m^2 as a continuous infusion for 22 hours in Phase 1, and will be administered at a dose of 225 mg/m^2 as a 24-hour infusion, 5 days a week, for 5 weeks in Phase 2.
Radiazione: Preoperative Radiotherapy
Radiotherapy will be delivered in fraction of 1.8 gray per day (Gy/day), 5 days a week for 5 weeks, i.e., a total dose of 45 Gy will be administered in 25 fractions over a period of 33 days.
Procedura: Surgery
Radical rectal excision based on the TME technique.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Tumor Sterilization Defined by ypT0-N0
Lasso di tempo: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Tumor sterilization was defined as the absence of residual tumor cells in the resected specimen including lymph nodes (ypT0-N0). The rate of sterilization of the tumoral specimen was assessed after surgery on the surgical specimen by local review. Analyses were performed for participants who have been operated as defined by the protocol (within the study and TME technique) and for all participants who have been operated. Reported is the percentage of participants with tumor sterilization.
After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Tumor Down-Staging (ypT0-pT2)
Lasso di tempo: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
A participant with a downstaging was defined as a participant with T3 (T describes the size of the original [primary] tumor) at inclusion and T2 or T1 or T0 after surgery, or with N+ (N describes lymph nodes involvement) at inclusion and N- after surgery and if T is equal at inclusion and after surgery. The clinical tumor-node-metastasis (cTNM) classification was used at inclusion and the pathological staging tumor and nodes (ypTN) classification after surgery. Reported is the percentage of participants with tumor downstaging of the surgical specimen according to the local review and centralized review.
After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Percentage of Participants With Local and Distant Recurrences
Lasso di tempo: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
The percentage of participants with a recurrence was described by type of recurrence (local and distant recurrence).
After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Percentage of Participants With Second Cancer, Local or Regional Recurrence, Distant Metastasis, or Death
Lasso di tempo: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Disease-Free Survival (DFS)
Lasso di tempo: From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years)
The DFS was defined as the time from the first treatment intake to disease recurrence assessed (second primary cancer, local or distant recurrence, distant metastases) or death from any cause. The DFS was analyzed using Kaplan-Meier method.
From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years)
Percentage of Participants Who Died
Lasso di tempo: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Overall Survival
Lasso di tempo: From the first treatment administration to the date of death (up to approximately 6 years)
The overall survival was defined as the time from the first treatment intake to death from any cause.
From the first treatment administration to the date of death (up to approximately 6 years)
Number of Cycles of Induction Chemotherapy
Lasso di tempo: 6 cycles (12 weeks; cycle length = 14 days)
6 cycles (12 weeks; cycle length = 14 days)
Number of Cycles of Chemotherapy
Lasso di tempo: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Number of Cycles of Radiotherapy
Lasso di tempo: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Percentage of Participants With Surgery
Lasso di tempo: Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment
The surgery involving a radical rectal excision using the TME technique.
Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 ottobre 2007

Completamento primario (Effettivo)

23 marzo 2016

Completamento dello studio (Effettivo)

23 marzo 2016

Date di iscrizione allo studio

Primo inviato

18 marzo 2009

Primo inviato che soddisfa i criteri di controllo qualità

18 marzo 2009

Primo Inserito (Stima)

19 marzo 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 agosto 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 luglio 2017

Ultimo verificato

1 luglio 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ML19202
  • 2006-003472-35 (Numero EudraCT)

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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