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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. september 2014 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

144

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Rekruttering
        • Cross Cancer Institute
        • Ledende efterforsker:
          • Michael B Sawyer, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Body Surface Area Dosing
Standard dosing arm based on body surface area
Andet: Standard dosing method arm: Cisplatin (chemotherapy) dosing based on body surface area
Cisplatin dosing calculated at the rate of 75 mg/m2
Eksperimentel: Lean Body Mass Dosing
Experimental dosing arm based on individual lean body mass
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Dose limiting toxicity rates
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Survival
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AHS Cancer Control Alberta

Samarbejdspartnere

Canadian Institutes of Health Research (CIHR)

Efterforskere

  • Ledende efterforsker: Michael B Sawyer, MD, Medical Oncologist, Cross Cancer Institute
  • Studiestol: Vickie Baracos, PhD, Grant Holder, Department of Oncology, University of Alberta

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2014

Primær færdiggørelse (Forventet)

1. september 2015

Studieafslutning (Forventet)

1. september 2015

Datoer for studieregistrering

Først indsendt

26. april 2012

Først indsendt, der opfyldte QC-kriterier

18. juni 2012

Først opslået (Skøn)

20. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. september 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. september 2014

Sidst verificeret

1. september 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Sawyer - Lung - CCI

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 .

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