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Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer

1. februar 2021 oppdatert av: Theodore Sunki Hong, Massachusetts General Hospital

Phase II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton or Photon RT Plus Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer

A standard treatment for patients with pancreatic cancer is standard photon radiation in combination with the chemotherapy drug, capecitabine. In this research study the investigators are using standard photon radiation or a different type of radiation therapy called proton beam radiation and adding hydroxychloroquine to be used in combination with capecitabine.

In this research study, the investigators are looking to determine if proton or photon beam radiation in combination with hydroxychloroquine and capecitabine is effective in controlling your cancer growth.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Subjects will be treated in cycles of 28 days. Hydroxychloroquine will be taken orally, daily until the day before surgery and will resume after surgery until study end.

Capecitabine will be taken orally, daily. Proton or photon radiation treatment will start on Week 2 and will be delivered daily (5 days in a row, but not weekends or holidays). Radiation treatment will be give on an outpatient basis at the Francis H. Burr Proton Center or the Clark Center for Radiation Oncology at Massachusetts General Hospital.

The following tests will be performed weekly: physical exam, routine blood tests, optional blood tests and an eye exam every 3 months while taking hydroxychloroquine.

Subjects will have surgery (any time between Weeks 5 to 9) and after surgery resume taking hydroxychloroquine. Subjects will have a follow up visit every 3 months which will include: physical exam, routine blood tests, eye exam, and tumor assessment by chest and abdominal-pelvic CT scan or MRI (every 6 months for the first 2 years and yearly for years 3-5).

Studietype

Intervensjonell

Registrering (Faktiske)

50

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Cytologic or histologic proof of pancreatic ductal carcinoma
  • Life expectancy > 3 months
  • Adequate organ and marrow function

Exclusion Criteria:

  • Evidence of metastatic disease
  • Pregnant or breast-feeding
  • Tumors in the body or tail of the pancreas
  • Serious concomitant systemic disorders such as significant cardiac or pulmonary morbidity (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifest by fever
  • Prior chemotherapy or radiation for treatment of the patient's pancreatic tumor
  • Diagnosis of other invasive carcinomas (except basal cell carcinomas/squamous cell carcinoma of the skin) with the last 5 years. Carcinoma in-situ is allowed.
  • Other serious uncontrolled medical conditions
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  • Known, existing uncontrolled coagulopathy
  • Prior systemic fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 6 months earlier). Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known DPD deficiency
  • Participation in any investigational drug study within 4 weeks preceding the start of study treatment
  • History of uncontrolled seizures, central nervous system disorders, or psychiatric disability
  • Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
  • Currently taking cimetidine
  • Receiving any other study agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine and HCQ
  • Already taking HCQ or chloroquine for other diagnosis
  • History of Grade 3 or greater retinopathy or keratitis

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Hydroxychloroquine
Hydroxychloroquine with chemoradiation
Legemiddel: Capecitabine
825 mg/m2 BID orally for a total of 10 days (M-F of weeks 2 and 3)
Andre navn:
  • Xeloda
Legemiddel: Hydroxychloroquine
400 mg BID from study day 1 until surgery. Dosing resumed upon discharge from hospital
Andre navn:
  • Plaquenil
Stråling: Proton or Photon Radiation Therapy
Daily, beginning Week 2 for 5 consecutive days

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free survival
Tidsramme: 2 years
To determine the progression-free survival of the addition of hydroxychloroquine to preoperative short course, chemoradiation therapy and adjuvant gemcitabine chemotherapy
2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pathologic response rate
Tidsramme: 2 years
To determine the complete pathologic response rate of preoperative capecitabine combined with hydroxychloroquine and short course radiation therapy in patients undergoing pancreaticoduodenectomy
2 years
Overall survival
Tidsramme: 2 years
To determine overall survival in patients treated with preoperative capecitabine + hydroxychloroquine and short course radiation therapy
2 years
Toxicity/Adverse events
Tidsramme: 2 years
To determine the toxicity of capecitabine + hydroxychloroquine and short course radiation therapy in patients with pancreatic cancer via analysis of frequency and grades of reported toxicities and adverse events, such as GI and hematologic toxicities, occurring in study participants
2 years
Surgical morbidity
Tidsramme: 2 years
To determine the surgical morbidity in patients undergoing pancreaticoduodenectomy who received preoperative capecitabine + hydroxychloroquine and external beam radiation therapy
2 years
Post-operative Mortality
Tidsramme: 2 weeks
To determine 30-day post-operative mortality after pancreaticoduodenectomy in patients who receive preoperative capecitabine and external beam radiation therapy
2 weeks
Biomarkers
Tidsramme: 2 years
To explore biomarkers of autophagy with hydroxychloroquine therapy and explore correlation with progression-free survival
2 years
Pathologic down-staging
Tidsramme: 2 years
To determine pathologic down-staging of hydroxychloroquine-based short course chemoradiation compared to a previous cohort (treated in prior study of neoadjuvant capecitabine + proton therapy)
2 years
Local control
Tidsramme: 2 years
To determine local tumor control at 2 years post treatment in study participants
2 years
Describe QoL
Tidsramme: 2 Years
To describe quality of life, symptom burden and mood in the study population
2 Years
Measure utilization of health services
Tidsramme: 2 years
Measure utilization of health services (ER, hospital and ICU visits) in the study population
2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Massachusetts General Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2011

Primær fullføring (Forventet)

1. januar 2022

Studiet fullført (Forventet)

1. januar 2023

Datoer for studieregistrering

Først innsendt

29. juli 2011

Først innsendt som oppfylte QC-kriteriene

14. desember 2011

Først lagt ut (Anslag)

16. desember 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. februar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. februar 2021

Sist bekreftet

1. februar 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 11-073

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