A phase II trial proposal of total neoadjuvant treatment with primary chemotherapy, stereotactic body radiation therapy, and intraoperative radiation therapy in borderline resectable pancreatic adenocarcinoma.
Adenocarcinoma
/ pathology
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Chemoradiotherapy
/ methods
Clinical Trials, Phase II as Topic
Combined Modality Therapy
Female
Follow-Up Studies
Humans
Intraoperative Care
Male
Middle Aged
Neoadjuvant Therapy
/ methods
Pancreatic Neoplasms
/ pathology
Prognosis
Radiosurgery
/ methods
Survival Rate
Intraoperative radiotherapy (IORT)
Locally advanced pancreatic cancer
Neoadjuvant therapy
Pancreatic cancer
Stereotactic body radiation therapy (SBRT)
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
16 Feb 2021
16 Feb 2021
Historique:
received:
13
04
2020
accepted:
04
02
2021
entrez:
17
2
2021
pubmed:
18
2
2021
medline:
7
9
2021
Statut:
epublish
Résumé
The current management guidelines recommend that patients with borderline resectable pancreatic adenocarcinoma (BRPC) should initially receive neoadjuvant chemotherapy. The addition of advanced radiation therapy modalities, including stereotactic body radiation therapy (SBRT) and intraoperative radiation therapy (IORT), could result in a more effective neoadjuvant strategy, with higher rates of margin-free resections and improved survival outcomes. In this single-center, single-arm, intention-to-treat, phase II trial newly diagnosed BRPC will receive a "total neoadjuvant" therapy with FOLFIRINOX (5-fluorouracil, irinotecan and oxaliplatin) and hypofractionated SBRT (5 fractions, total dose of 30 Gy with simultaneous integrated boost of 50 Gy on tumor-vessel interface). Following surgical exploration or resection, IORT will be also delivered (10 Gy). The primary endpoint is 3-year survival. Secondary endpoints include completion of neoadjuvant treatment, resection rate, acute and late toxicities, and progression-free survival. In the subset of patients undergoing resection, per-protocol analysis of disease-free and disease-specific survival will be performed. The estimated sample size is 100 patients over a 36-month period. The trial is currently recruiting. NCT04090463 at clinicaltrials.gov.
Sections du résumé
BACKGROUND
BACKGROUND
The current management guidelines recommend that patients with borderline resectable pancreatic adenocarcinoma (BRPC) should initially receive neoadjuvant chemotherapy. The addition of advanced radiation therapy modalities, including stereotactic body radiation therapy (SBRT) and intraoperative radiation therapy (IORT), could result in a more effective neoadjuvant strategy, with higher rates of margin-free resections and improved survival outcomes.
METHODS/DESIGN
METHODS
In this single-center, single-arm, intention-to-treat, phase II trial newly diagnosed BRPC will receive a "total neoadjuvant" therapy with FOLFIRINOX (5-fluorouracil, irinotecan and oxaliplatin) and hypofractionated SBRT (5 fractions, total dose of 30 Gy with simultaneous integrated boost of 50 Gy on tumor-vessel interface). Following surgical exploration or resection, IORT will be also delivered (10 Gy). The primary endpoint is 3-year survival. Secondary endpoints include completion of neoadjuvant treatment, resection rate, acute and late toxicities, and progression-free survival. In the subset of patients undergoing resection, per-protocol analysis of disease-free and disease-specific survival will be performed. The estimated sample size is 100 patients over a 36-month period. The trial is currently recruiting.
TRIAL REGISTRATION
BACKGROUND
NCT04090463 at clinicaltrials.gov.
Identifiants
pubmed: 33593311
doi: 10.1186/s12885-021-07877-7
pii: 10.1186/s12885-021-07877-7
pmc: PMC7885611
doi:
Banques de données
ClinicalTrials.gov
['NCT04090463']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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