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A Study Comparing Chemotherapy Dosing Based on Either Standard Body Surface Area or Lean Body Mass in Patients With Advanced Lung Cancer

26 settembre 2014 aggiornato da: AHS Cancer Control Alberta

A Phase II Double Blind Randomized Trial Comparing Standard Dosing Based on Body Surface Area Versus Dosing Based on Personalized Lean Body Mass in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Receiving First Line Cisplatin Based Chemotherapy

Cancer patients are highly variable in their body composition, specifically in the proportion of fat and muscle. Some patients tend to gain fat and lose muscle (or lean body mass) at the same time. These patients can develop severe muscle wasting, termed sarcopenia. Patients with sarcopenia have more severe treatment related toxicity requiring delays, dose reductions and stopping of treatment, and have reduced survival. One potential explanation for this is that patients with sarcopenia have a reduced volume of lean body mass into which chemotherapy drugs are distributed, resulting in a higher concentration and greater toxicity. This study will randomize lung cancer patients to either the standard dosing strategy based on body surface area or experimental, personalized dosing based on lean body mass. Based on retrospective findings in this patient population, the investigators expect to find that severe toxicity will be reduced for sarcopenic patients on the personalized dosing arm based on lean body mass.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Retrospective findings of NSCLC patients treated with a cisplatin based chemotherapy regimen show that although all were given cisplatin at the standard rate of 75 mg/m2 according to lean body mass, when this was expressed in relation to individual lean body mass, there was a high degree of variation. Incidence of dose limiting toxicity was 41% in patients whose dose was within + 25% of the median value. However, sarcopenic patients received on average a 35% higher dose and 80% of these patients experienced severe toxicity requiring dose reduction or termination of therapy, a clinically unacceptable level. The relatively muscular subset of patients with higher lean body mass had a reduced level of severe toxicity compared to those at the median dose. These findings have led to the design of a study with the goal of reducing high levels of toxicity in sarcopenic patients. If the expected level of dose limiting toxicity in sarcopenic patients is 80% based on the standard method of dosing, this could be expected to be reduced to the median value of 41% dose limiting toxicity by the administration of cisplatin scaled to individual lean body mass. Hypothesis: Levels of severe toxicity in sarcopenic patients may be reduced to clinically acceptable levels by cisplatin dosing scaled to 3.1 mg/kg lean body mass compared with standard dosing of 75 mg/m2 based on body surface area.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

144

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.

Contatto studio

Luoghi di studio

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Reclutamento
        • Cross Cancer Institute
        • Investigatore principale:
          • Michael B Sawyer, MD

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Recommendation from treating oncologist to receive a cisplatin based chemotherapy regimen, specifically either cisplatin/vinorelbine or cisplatin/gemcitabine
  • > or = 18 years of age
  • Histologically proven diagnosis of non-small cell lung cancer, Stage IIIB or IV
  • Adequate renal function: creatinine < 1.5 mg/dL or < 132 µmol/L and creatinine clearance of > 45 mL/min using the Cockcroft-Gault formula
  • Adequate hepatic function: bilirubin < 1.5 mg/dL or < 25 µmol/L and AST and ALT < 2 times upper limit of normal, unless there is evidence of liver metastases, in which case < 5 times upper limit of normal
  • Adequate hematological function: absolute neutrophil count (ANC) > 1.5 x 109/L and platelets > 100 x 109/L and hemoglobin > 100 g/L
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
  • Negative serum pregnancy test for women of childbearing potential. Women and men of child bearing potential must use effective contraception defined as the simultaneous use of two reliable methods unless abstinence is the chosen method.
  • Life expectancy of > 4 months in the opinion of the treating oncologist
  • Prior radiotherapy is allowed (unless > 25% of bone marrow stores) if this radiation was > 4 weeks before study entry and patient has fully recovered from toxicity of this treatment
  • Willingness to comply with the study protocol
  • Ability to give written informed consent with the understanding that it may be withdrawn at any time without prejudice

Exclusion Criteria:

  • Pregnant or lactating women
  • Brain metastases (a CT or MRI is not required to rule out brain metastases unless there is clinical suspicion)
  • Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix, in situ ductal breast cancer, non-melanoma skin cancer or low grade bladder cancer
  • Patients who have had major surgery within three weeks of enrollment without a full recovery
  • Prior treatment with any anticancer therapy
  • Patients who have tested positive for HIV
  • Any significant medical or psychiatric condition that, in the opinion of the investigator, will exclude the patient from the study for compliance or safety reasons

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: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Body Surface Area Dosing
Standard dosing arm based on body surface area
Altro: Standard dosing method arm: Cisplatin (chemotherapy) dosing based on body surface area
Cisplatin dosing calculated at the rate of 75 mg/m2
Sperimentale: Lean Body Mass Dosing
Experimental dosing arm based on individual lean body mass
Altro: Experimental dosing method arm: Cisplatin (chemotherapy) dosing based on individual lean body mass
Cisplatin dosing calculated at the rate of 3.10 mg/kg lean body mass

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Dose limiting toxicity rates
Lasso di tempo: Assessed weekly until patients come off study (an expected average of 9 weeks)
Assessed weekly until patients come off study (an expected average of 9 weeks)
Number of Cycles completed
Lasso di tempo: Assessed weekly until patients come off study (an expected average of 9 weeks)
Assessed weekly until patients come off study (an expected average of 9 weeks)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Survival
Lasso di tempo: Assessed every 60 days from the date of removal from the trial (an expected average of 9 months)
If a patient has deceased, the date of death is recorded. If a patient is alive, the status is checked again in another 60 days. This is carried out through health records and not through direct contact with the patient.
Assessed every 60 days from the date of removal from the trial (an expected average of 9 months)

Collaboratori e investigatori

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

Sponsor

AHS Cancer Control Alberta

Collaboratori

Canadian Institutes of Health Research (CIHR)

Investigatori

  • Investigatore principale: Michael B Sawyer, MD, Medical Oncologist, Cross Cancer Institute
  • Cattedra di studio: Vickie Baracos, PhD, Grant Holder, Department of Oncology, University of Alberta

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 luglio 2014

Completamento primario (Anticipato)

1 settembre 2015

Completamento dello studio (Anticipato)

1 settembre 2015

Date di iscrizione allo studio

Primo inviato

26 aprile 2012

Primo inviato che soddisfa i criteri di controllo qualità

18 giugno 2012

Primo Inserito (Stima)

20 giugno 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

30 settembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 settembre 2014

Ultimo verificato

1 settembre 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Sawyer - Lung - CCI

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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