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Radioterapia corporea stereotassica ipofrazionata e fluorouracile o capecitabina con o senza acido zoledronico nel trattamento di pazienti con carcinoma pancreatico localmente avanzato

2 novembre 2026 aggiornato da: University of Nebraska

Uno studio randomizzato di fase II sull'efficacia e la sicurezza della radioterapia stereotassica ipofrazionata e 5FU o capecitabina con e senza Zometa in pazienti con adenocarcinoma pancreatico localmente avanzato

Pancreatic cancer, most commonly adenocarcinoma, is the fourth leading cause of cancer death in the United States. The mainstay of management centers on surgical resection (if resectable) and although low (15% to 20%), resectability rates are associated with dismal survival. An estimated 80% to 85% of the patients recur after surgical resection, leading to a median survival of 20 to 24 months and potentially even less depending on lymph nodal involvement or positive margins. The rationale for utilizing neoadjuvant therapy, commonly fluoropyrimidine-based or gemcitabine based chemotherapy or Chemoradiotherapy (CRT), involves possibly down staging borderline resectable and unresectable patients, potentially making them resectable candidates.

This randomized phase II trial will study how well hypofractionated stereotactic body radiation therapy (SBRT) and fluorouracil or capecitabine with or without zoledronic acid work in treating participants with pancreatic cancer that has spread to nearby tissue or lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor using smaller doses over several days which may cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Zoledronic acid is used in cancer patients to reduce cancer symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid may work better in treating pancreatic cancer.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Pancreatic cancer, most commonly adenocarcinoma, is the fourth leading cause of cancer death in the United States. The mainstay of management centers on surgical resection (if resectable) and although low (15% to 20%), resectability rates are associated with dismal survival. An estimated 80% to 85% of the patients recur after surgical resection, leading to a median survival of 20 to 24 months and potentially even less depending on lymph nodal involvement or positive margins. The rationale for utilizing neoadjuvant therapy, commonly fluoropyrimidine-based or gemcitabine based chemotherapy or Chemoradiotherapy (CRT), involves possibly down staging borderline resectable and unresectable patients, potentially making them resectable candidates.

This randomized phase II trial will study how well hypofractionated stereotactic body radiation therapy (SBRT) and fluorouracil or capecitabine with or without zoledronic acid work in treating participants with pancreatic cancer that has spread to nearby tissue or lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor using smaller doses over several days which may cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Zoledronic acid is used in cancer patients to reduce cancer symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid may work better in treating pancreatic cancer.

The primary study objective is to evaluate the efficacy of hypofractionated radiation therapy concurrently with zoledronic acid (Zometa) and fluorouracil or capecitabine. Other study objectives include examining the toxicity of Zometa when used concurrently with hypofractionated radiation therapy, evaluating local failure-free survival and overall survival, determining surgical resection and tumor response rates, measuring Zometa pharmacokinetics, evaluating tumor and organ motion and determining the effect those on the dosimetry, local control and survival. Post-treatment follow-up is for 30 days, then every 3 months for the first year, every 4 months for the second year, and every 6 months thereafter.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

46

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

    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68198
        • University of Nebraska Medical Center

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

19 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Pathologically confirmed pancreatic adenocarcinoma, either initially diagnosed or recurrent locally advanced disease. The maximum dimension of the treatment target must be =<10 cm. Locally advanced disease defined as: T 1-2N+MO or T3-4 NxMo, or borderline resectable and unresectable adenocarcinoma without distant metastatic disease or resectable T3-4 NxMo disease or M1 with controlled distant disease
  • Inoperable conditions with resectable disease (T1-2NoMo)
  • Karnofsky performance status of 60% or better. Received recent chemotherapy for pancreatic cancer or completed chemotherapy > 5 years ago for malignancies other than pancreatic cancer with no evidence of the second malignancy at study entry
  • Radiation therapy completed > 5 years ago for malignancies other than pancreatic cancer and whose radiation therapy field is not overlapping with the 20% isodose line of current radiation field and no evidence of the second malignancy at study entry
  • All malignant disease must be able to be encompassed within a single irradiation field
  • Absolute neutrophil count (ANC) greater than or equal to 1500/uL
  • Radiographically assessable disease
  • Platelet count greater than or equal to 100,000/uL
  • Serum creatinine less than or equal to 2.0 mg/dL and total bilirubin less than or equal to 2.0 mg/dL in the absence of biliary obstruction. If biliary obstruction is present, biliary decompression will be required, either endoscopic placement of a biliary stent or percutaneous transhepatic. Once biliary drainage has been established, institution of protocol therapy may proceed when the total bilirubin falls to 4.0 mg/dL or lower
  • Calculated creatinine clearance of >= 35.
  • Awareness of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts

Exclusion Criteria:

  • Known allergy to Zometa or to anti-emetics appropriate in conjunction with protocol-directed therapy
  • Uncontrolled inter-current illness that might jeopardize the ability of the subject to receive the protocol therapy with reasonable safety. This may include, but not limited to, ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure, unstable angina pectoris, or serious, uncontrolled cardiac arrhythmia
  • Pregnant and nursing women
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, adequately treated non-invasive carcinomas, or be disease-free for at least 5 years from other cancers
  • Active duodenal ulcer or bleeding or history of a gastrointestinal fistula or perforation or other significant bowel problems (severe nausea, vomiting, inflammatory bowel disease and significant bowel resection)
  • Known human immunodeficiency virus (HIV) infection, or hepatic insufficiency
  • Not currently receiving or have received Zometa within 3 weeks prior to study treatment with Zometa

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
Comparatore attivo: Arm A (chemotherapy, radiation therapy)

Participants undergo hypofractionated stereotactic body radiation therapy in 5 fractions on days 1-5. Participants receive fluorouracil IV over 24 hours on day 1 weekly for 4 weeks or capecitabine by mouth every 12 hours starting the evening before day 1 of radiation therapy for 4 weeks as per standard of care. Participants then undergo surgery 6-8 weeks after completion of radiation therapy.

Correlative studies

Correlative studies

Given by mouth (PO)

Altri nomi:
  • Xeloda
  • Ro 09-1978/000

Given Intravenously (IV)

Altri nomi:
  • 5-FU
  • 5-Fluracile
  • Fluracil
  • 5-Fluoro-2,4(1H, 3H)-pirimidinedione
  • 5-Fluorouracile
  • Accu Site
  • Carac
  • Fluorouracile
  • Fluuracile
  • Flurablastina
  • Fluracedil
  • Fluril
  • Fluroblastina
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757

Undergo hypofractionated stereotactic radiotherapy

Altri nomi:
  • SBR
  • SAB
  • Radioterapia corporea ablativa stereotassica
Sperimentale: Arm B (zoledronic acid, chemotherapy, radiation therapy)

Participants receive zoledronic acid IV over a minimum of 15 minutes 1 week prior to radiation therapy. Participants undergo hypofractionated stereotactic body radiation therapy and receive treatment with fluorouracil IV or capecitabine by mouth as in Arm A. Participants then undergo surgery 6-8 weeks after completion of radiation therapy.

Correlative studies

Correlative studies

Given by mouth (PO)

Altri nomi:
  • Xeloda
  • Ro 09-1978/000

Given Intravenously (IV)

Altri nomi:
  • 5-FU
  • 5-Fluracile
  • Fluracil
  • 5-Fluoro-2,4(1H, 3H)-pirimidinedione
  • 5-Fluorouracile
  • Accu Site
  • Carac
  • Fluorouracile
  • Fluuracile
  • Flurablastina
  • Fluracedil
  • Fluril
  • Fluroblastina
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757

Undergo hypofractionated stereotactic radiotherapy

Altri nomi:
  • SBR
  • SAB
  • Radioterapia corporea ablativa stereotassica

Given IV

Altri nomi:
  • Reclast
  • Zometa
  • CGP 42446
  • CGP42446A
  • Acido [1-idrossi-2-(1H-imidazol-1-il)etiliden]bisfosfonico
  • NDC-Zoledronato
  • ZOLL 446

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Local Control With and Without Zometa at Four Months in Follow-up
Lasso di tempo: At 4 months in follow-up

Local control will be assessed using three-dimensional (3D) computed tomography (CT). The primary tumor will be contoured using Varian planning software, and tumor volume will be measured at baseline and at 4 months post-treatment. Local control is defined as absence of disease progression, with progression defined as a ≥25% increase in tumor volume. Tumor response will also be assessed using RECIST-based criteria (≥20% increase in tumor diameter) as a supportive analysis.

At 4 months in follow-up
Local Control With and Without Zometa at Eight Months in Follow-up
Lasso di tempo: At 8 months in follow-up

Local control will be assessed using three-dimensional (3D) computed tomography (CT). The primary tumor will be contoured using Varian planning software, and tumor volume will be measured at baseline and at 8 months post-treatment. Local control is defined as absence of disease progression, with progression defined as a ≥25% increase in tumor volume. Tumor response will also be assessed using RECIST-based criteria (≥20% increase in tumor diameter) as a supportive analysis.

At 8 months in follow-up
Local Control With and Without Zometa at Twelve Months in Follow-up
Lasso di tempo: At 12 months in follow-up

Local control will be assessed using three-dimensional (3D) computed tomography (CT). The primary tumor will be contoured using Varian planning software, and tumor volume will be measured at baseline and at 12 months post-treatment. Local control is defined as absence of disease progression, with progression defined as a ≥25% increase in tumor volume. Tumor response will also be assessed using RECIST-based criteria (≥20% increase in tumor diameter) as a supportive analysis.

At 12 months in follow-up

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Grade 3 and Above Adverse Events With and Without Zoledronic Acid
Lasso di tempo: Up to 30 days after treatment

Grade 3 and above adverse events (AE) will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.

Up to 30 days after treatment
Failure-free Survival With and Without Zometa
Lasso di tempo: From date of administration of study drug to the date of any failure, assessed up to 5 years

Time to any failure (disease progression or recurrence determined by imaging, or death) will be analyzed using Kaplan-Meier method between participants receiving Zometa and those who don't.

From date of administration of study drug to the date of any failure, assessed up to 5 years
Overall Survival With and Without Zometa
Lasso di tempo: From date of administration of study drug to the date of death, assessed up to 5 years

Time to death will be analyzed using Kaplan-Meier method between participants receiving Zometa and those who don't.

From date of administration of study drug to the date of death, assessed up to 5 years
Surgically Complete Resection Rate With and Without Zometa
Lasso di tempo: Immediately after surgery

The number and proportion of participants undergoing complete resection (negative margin) will be determined between participants receiving Zometa and those who don't.

Immediately after surgery
Pathologic Response After Resection With and Without Zometa
Lasso di tempo: Immediately after surgery

The pathologic response will be scored from 0-9 by a pathologist, 0 is no response and 9 is complete response between participants receiving Zometa and those who don't.

Immediately after surgery
All-Cause Mortality
Lasso di tempo: From date of administration of study drug to the date of death, assessed up to 10 years

All anticipated and unanticipated deaths due to any cause

From date of administration of study drug to the date of death, assessed up to 10 years

Collaboratori e investigatori

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

Sponsor

Collaboratori

Investigatori

  • Investigatore principale: Chi Lin, MD, PhD, University of Nebraska

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 marzo 2017

Completamento primario (Effettivo)

12 dicembre 2023

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

28 febbraio 2017

Primo inviato che soddisfa i criteri di controllo qualità

2 marzo 2017

Primo Inserito (Effettivo)

8 marzo 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 0552-16-FB
  • P30CA036727 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2016-01360 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

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 .