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Adjuvant Breast Cancer Study of the Netherlands Working Party for Autotransplantation in Solid Tumors

24 febbraio 2009 aggiornato da: University Medical Center Groningen

A Prospective Randomized Feasibility and Phase II Adjuvant Breast Cancer Study of the Netherlands Working Party for Autotransplantation in Solid Tumors.

Objectives of the study:

This randomized multicenter phase II study compares the tolerability, toxicity and quality of life between two high-dose chemotherapy regimens based on cyclophosphamide, thiotepa and carboplatin.

Regimen A: full dose CTC. Regimen B: two courses of CTC (tCTC) with 33% dose reduction.

Primary endpoints are:

  • Maximum degree of non-hematological toxicity.

Secondary endpoint:

  • Total number of hospital days.
  • Quality of life evaluations during and following high-dose chemotherapy (up to 1 year).
  • Effect of therapeutic dose monitoring of CTC or tCTC.

Trial design:

This investigation is a multicenter prospective randomized phase II study. Patients eligible for the study will be identified after mastectomy or wide tumor excision with axillary clearance. Following randomization, all patients will receive four courses of cyclophosphamide, epirubicin and fluorouracil (FEC). Patients with early progressive disease at any time will be taken off study. The first chemotherapy course must be given as soon as possible after the surgical procedure, preferably within 3 weeks, but not later than 6 weeks since primary surgery. After the third or fourth FEC course G-CSF is administered and peripheral stem cells will be harvested. All radiation therapy (including radiation therapy administered as part of a breast conserving strategy) must be postponed until all chemotherapy has been concluded.

Questionnaires, comprising the Rotterdam Symptom Checklist (RSCL) and the Short-Form General Health Survey (SF-36) will be sent by mail before randomization, after chemotherapy, 3 months thereafter, further on every l/2 yr till at least 1 year follow-up as performed earlier. [6, 28, 29].

All patients will be randomized before the initiation of chemotherapy.

  • The 'standard' treatment arm will include 4 courses of FEC followed by high-dose chemotherapy with a single course of full dose CTC followed by peripheral stem cell reinfusion. Subsequently, conventional external beam radiotherapy to the breast or chest wall and to the regional lymph node areas including the axilla and the parasternal area will be administered following guidelines of the individual center. Patients with hormone receptor positive disease will go on to receive 5 years of tamoxifen. Patients with receptor positive disease who have not entered menopause will be advised to undergo ovarian ablation as well.
  • The 'experimental' treatment arm will be identical to the 'standard' one, except that the single course of CTC will be replaced by 2 courses of tCTC each followed by peripheral stem cell reinfusion.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

High-dose chemotherapy with the alkylating agent combination CTC appears to add significantly to the efficacy of conventional dose chemotherapy in patients with high-risk breast cancer, provided that the HER-2/neu gene is not amplified in the tumor. As a high-dose chemotherapy regimen, CTC is associated with significant toxicity [31,32]. Although high-dose alkylating therapy seems to be effective, there is virtually nothing known about the dose-response curve for this combination (for a detailed discussion see the classical paper by E. Frei III [32]. If one assumes that the efficacy increase levels off with increasing dose, the efficacy of tCTC might be almost as great as that of CTC, but with considerably less toxicity. In addition, two closely spaced courses of tCTC might further increase the efficacy of the regimen. There are some suggestions that a double transplant may be more effective than a single one, in multiple myeloma and in Ewing sarcoma. A similar suggestion has also been made for breast cancer (study of Nitz et al ref 4, table 1).

Tipo di studio

Interventistico

Iscrizione (Anticipato)

50

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

  • Olanda
      • Amsterdam, Olanda, 1066 CX
        • The Netherlands Cancer Institute
      • Amsterdam, Olanda, 1105 AZ
        • Academic Medical Center
      • Amsterdam, Olanda, 1007 MB
        • Free University Hospital
      • Enschede, Olanda, 7511 JX
        • Medisch Spectrum Twente
      • Groningen, Olanda, 9713 GZ
        • University Medical Centre Groningen
      • Leiden, Olanda, 2333 JS
        • Leiden University Medical Centre
      • Maastricht, Olanda, 6202 AZ
        • University Hospital Maastricht
      • Nijmegen, Olanda, 6525 GA
        • University Medical Centre Nijmegen St. Radboud
      • Rotterdam, Olanda, 3075 EA
        • Erasmus MC, Daniel den Hoed Cancer Center
      • Utrecht, Olanda, 3584 CX
        • University Medical Centre Utrecht

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 50 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion criteria:

  1. Modified radical mastectomy (or breast conserving surgery) and axillary clearance, histologically confirmed stage IIA, IIB or IIIA adenocarcinoma (excluding supraclavicular lymph nodes) of the breast, with 4 or more involved axillary lymph nodes. Presence of tumor cells near or in the resection margins at microscopic examination is acceptable
  2. The primary tumor must be immunohistochemically negative for HER-2/neu expression. An immunohistochemistry score of 1+ is also acceptable. A score of 3+ is not acceptable. A score of 2+ is only acceptable if a FISH analysis (or equivalent) has clearly shown that there is no HER-2/neu gene-amplification
  3. No prior chemotherapy or radiotherapy
  4. No evidence of distant metastases
  5. Age < 50 years
  6. Performance status (ECOG-ZUBROD) 0 or 1;
  7. Normal bone marrow function, WBC > 4.0 x 109/l, platelets > 100 x 109/l;
  8. Adequate renal function (creatinine clearance > 60 ml/min.);
  9. Adequate hepatic function (serum bilirubin < 25 umol/l);
  10. Study treatment must begin within 6 weeks of surgery;
  11. No other malignancy except adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin;
  12. No significant prior or concomitant disorder that might interfere with adherence to the intensive treatment regimen, including but not limited to a history of angina, myocardial infarction or heart failure, severe lung function impairment, peptic ulcer disease, etc.;
  13. Availability for follow-up.

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)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Maximum degree of non-hematological toxicity.

Misure di risultato secondarie

Misura del risultato
Total number of hospital days
Quality of life evaluations during and following high-dose chemotherapy (up to 1 year)

Collaboratori e investigatori

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

Sponsor

University Medical Center Groningen

Investigatori

  • Direttore dello studio: Elisabeth G.E. de Vries, MD, PhD, University Medical Center Groningen
  • Direttore dello studio: Sjoerd Rodenhuis, MD, PhD, The Netherlands Cancer Institute

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

1 ottobre 2004

Date di iscrizione allo studio

Primo inviato

23 febbraio 2009

Primo inviato che soddisfa i criteri di controllo qualità

24 febbraio 2009

Primo Inserito (Stima)

25 febbraio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

25 febbraio 2009

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 febbraio 2009

Ultimo verificato

1 febbraio 2009

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • METc 2004/110
  • CKTO 2005-15

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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