Study protocol: a multi-centre randomised study of induction chemotherapy followed by capecitabine ± nelfinavir with high- or standard-dose radiotherapy for locally advanced pancreatic cancer (SCALOP-2).
Adenocarcinoma
/ pathology
Adolescent
Adult
Aged
Aged, 80 and over
Antineoplastic Agents
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Capecitabine
/ administration & dosage
Chemoradiotherapy
Combined Modality Therapy
Female
Humans
Induction Chemotherapy
Male
Middle Aged
Nelfinavir
/ administration & dosage
Neoplasms, Second Primary
/ pathology
Pancreatic Neoplasms
/ pathology
Radiation Dosage
Survival Analysis
Treatment Outcome
Young Adult
Chemoradiation
Gemcitabine and nab-paclitaxel (GEMABX)
Locally advanced pancreatic cancer (LAPC)
Nelfinavir
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
04 Feb 2019
04 Feb 2019
Historique:
received:
09
10
2018
accepted:
16
01
2019
entrez:
6
2
2019
pubmed:
6
2
2019
medline:
31
8
2019
Statut:
epublish
Résumé
Induction chemotherapy followed by chemoradiation is a treatment option for patients with locally advanced pancreatic cancer (LAPC). However, overall survival is comparable to chemotherapy alone and local progression occurs in nearly half of all patients, suggesting chemoradiation strategies should be optimised. SCALOP-2 is a randomised phase II trial testing the role of radiotherapy dose escalation and/or the addition of the radiosensitiser nelfinavir, following induction chemotherapy of gemcitabine and nab-paclitaxel (GEMABX). A safety run-in phase (stage 1) established the nelfinavir dose to administer with chemoradiation in the randomised phase (stage 2). Patients with locally advanced, inoperable, non-metastatic pancreatic adenocarcinoma receive three cycles of induction GEMABX chemotherapy prior to radiological assessment. Those with stable/responding disease are eligible for further trial treatment. In Stage 1, participants received one further cycle of GEMABX followed by capecitabine-chemoradiation with escalating doses of nelfinavir in a rolling-six design. Stage 2 aims to register 262 and randomise 170 patients with responding/stable disease to one of five arms: capecitabine with high- (arms C + D) or standard-dose (arms A + B) radiotherapy with (arms A + C) or without (arms B + D) nelfinavir, or three more cycles of GEMABX (arm E). Participants allocated to the chemoradiation arms receive another cycle of GEMABX before chemoradiation begins. Co-primary outcomes are 12-month overall survival (radiotherapy dose-escalation question) and progression-free survival (nelfinavir question). Secondary outcomes include toxicity, quality of life, disease response rate, resection rate, treatment compliance, and CA19-9 response. SCALOP-2 incorporates a detailed radiotherapy quality assurance programme. SCALOP-2 aims to optimise chemoradiation in LAPC and incorporates a modern induction regimen. Eudract No: 2013-004968-56; ClinicalTrials.gov : NCT02024009.
Sections du résumé
BACKGROUND
BACKGROUND
Induction chemotherapy followed by chemoradiation is a treatment option for patients with locally advanced pancreatic cancer (LAPC). However, overall survival is comparable to chemotherapy alone and local progression occurs in nearly half of all patients, suggesting chemoradiation strategies should be optimised. SCALOP-2 is a randomised phase II trial testing the role of radiotherapy dose escalation and/or the addition of the radiosensitiser nelfinavir, following induction chemotherapy of gemcitabine and nab-paclitaxel (GEMABX). A safety run-in phase (stage 1) established the nelfinavir dose to administer with chemoradiation in the randomised phase (stage 2).
METHODS
METHODS
Patients with locally advanced, inoperable, non-metastatic pancreatic adenocarcinoma receive three cycles of induction GEMABX chemotherapy prior to radiological assessment. Those with stable/responding disease are eligible for further trial treatment. In Stage 1, participants received one further cycle of GEMABX followed by capecitabine-chemoradiation with escalating doses of nelfinavir in a rolling-six design. Stage 2 aims to register 262 and randomise 170 patients with responding/stable disease to one of five arms: capecitabine with high- (arms C + D) or standard-dose (arms A + B) radiotherapy with (arms A + C) or without (arms B + D) nelfinavir, or three more cycles of GEMABX (arm E). Participants allocated to the chemoradiation arms receive another cycle of GEMABX before chemoradiation begins. Co-primary outcomes are 12-month overall survival (radiotherapy dose-escalation question) and progression-free survival (nelfinavir question). Secondary outcomes include toxicity, quality of life, disease response rate, resection rate, treatment compliance, and CA19-9 response. SCALOP-2 incorporates a detailed radiotherapy quality assurance programme.
DISCUSSION
CONCLUSIONS
SCALOP-2 aims to optimise chemoradiation in LAPC and incorporates a modern induction regimen.
TRIAL REGISTRATION
BACKGROUND
Eudract No: 2013-004968-56; ClinicalTrials.gov : NCT02024009.
Identifiants
pubmed: 30717707
doi: 10.1186/s12885-019-5307-z
pii: 10.1186/s12885-019-5307-z
pmc: PMC6360784
doi:
Substances chimiques
Antineoplastic Agents
0
Capecitabine
6804DJ8Z9U
Nelfinavir
HO3OGH5D7I
Banques de données
ClinicalTrials.gov
['NCT02024009']
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
121Subventions
Organisme : Pancreatic Cancer UK
ID : FLF2015_06_OXFORD
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_PC_12001/2
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_UU_00001/2
Pays : United Kingdom
Organisme : Cancer Research UK
ID : CRUK/07/040
Pays : United Kingdom
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