Study protocol: multi-centre, randomised controlled clinical trial exploring stromal targeting in locally advanced pancreatic cancer; STARPAC2
Abstract Background Pancreatic cancer (PDAC: pancreatic ductal adenocarcinoma, the commonest form), a lethal disease, is best treated with surgical excision but is feasible in less than a fifth of patients. Around a third of patients presentlocally advanced, inoperable, non-metastatic (laPDAC), whos...
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BMC
2025-01-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-024-13333-z |
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| author | Hemant M. Kocher BCI-STARPAC2 team BPTB team Precision-Panc team Peter Sasieni Pippa Corrie Mairéad G. McNamara Debashis Sarker Fieke E. M. Froeling Alan Christie Roopinder Gillmore Khurum Khan David Propper |
| author_facet | Hemant M. Kocher BCI-STARPAC2 team BPTB team Precision-Panc team Peter Sasieni Pippa Corrie Mairéad G. McNamara Debashis Sarker Fieke E. M. Froeling Alan Christie Roopinder Gillmore Khurum Khan David Propper |
| author_sort | Hemant M. Kocher |
| collection | DOAJ |
| description | Abstract Background Pancreatic cancer (PDAC: pancreatic ductal adenocarcinoma, the commonest form), a lethal disease, is best treated with surgical excision but is feasible in less than a fifth of patients. Around a third of patients presentlocally advanced, inoperable, non-metastatic (laPDAC), whose stadrd of care is palliative chemotherapy; a small minority are down-sized sufficiently to enable surgical excision. We propose a phase II clinical trial to test whether a combination of standard chemotherapy (gemcitabine & nab-Paclitaxel: GEM-NABP) and repurposing All Trans Retinoic Acid (ATRA) to target the stroma may extend progression-free survival and enable successful surgical resection for patients with laPDAC, since data from phase IB clinical trial demonstrate safety of GEM-NABP-ATRA combination to patients with advanced PDAC with potential therapeutic benefit. Methods Patients with laPDAC will receive at least six cycles of GEM-NABP with 1:1 randomisation to receive this with or without ATRA to assess response, until progression or intolerance. Those with stable/responding disease may undergo surgical resection. Primary endpoint is progression free survival (PFS) defined as the time from the date of randomisation to the date of first documented tumour progression (response evaluation criteria in solid tumours [RECIST] v1.1) or death from any cause, whichever occurs first. Secondary endpoints include objective response rate (ORR), overall survival (OS), safety and tolerability, surgical resection rate, R0 surgical resection rate and patient reported outcome measures (PROMS) as measured by questionnaire EQ-5D-5L. Exploratory endpoints include a decrease or increase in CA19-9 and serum Vitamin A over time correlated with ORR, PFS, and OS. Discussion STARPAC2 aims to assess the role of stromal targeting in laPDAC. Trial registration EudraCT: 2019–004231-23; NCT04241276; ISRCTN11503604. |
| format | Article |
| id | doaj-art-33309697d7444f63afea0fd8679f5db5 |
| institution | Kabale University |
| issn | 1471-2407 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj-art-33309697d7444f63afea0fd8679f5db52025-01-26T12:38:02ZengBMCBMC Cancer1471-24072025-01-012511810.1186/s12885-024-13333-zStudy protocol: multi-centre, randomised controlled clinical trial exploring stromal targeting in locally advanced pancreatic cancer; STARPAC2Hemant M. Kocher0BCI-STARPAC2 team1BPTB team2Precision-Panc teamPeter Sasieni3Pippa Corrie4Mairéad G. McNamara5Debashis Sarker6Fieke E. M. Froeling7Alan Christie8Roopinder Gillmore9Khurum Khan10David Propper11Barts Cancer Institute and Wolfson Institute of Public Health, Mary University of London, John Vane Science CentreBarts Cancer Institute and Wolfson Institute of Public Health, Mary University of London, John Vane Science CentreBarts Cancer Institute and Wolfson Institute of Public Health, Mary University of London, John Vane Science CentreBarts Cancer Institute and Wolfson Institute of Public Health, Mary University of London, John Vane Science CentreCambridge University Hospitals NHS Foundation TrustDivision of Cancer Sciences, Department of Medical Oncology, University of Manchester &, The Christie NHS Foundation TrustGuy’s and St Thomas’ NHS Foundation TrustUniversity of Glasgowand, NHS Greater Glasgow and Clyde Edinburgh Cancer Centre, NHS LothianRoyal Free London NHS Foundation TrustUniversity College London Hospitals NHS Foundation TrustBarts Cancer Institute and Wolfson Institute of Public Health, Mary University of London, John Vane Science CentreAbstract Background Pancreatic cancer (PDAC: pancreatic ductal adenocarcinoma, the commonest form), a lethal disease, is best treated with surgical excision but is feasible in less than a fifth of patients. Around a third of patients presentlocally advanced, inoperable, non-metastatic (laPDAC), whose stadrd of care is palliative chemotherapy; a small minority are down-sized sufficiently to enable surgical excision. We propose a phase II clinical trial to test whether a combination of standard chemotherapy (gemcitabine & nab-Paclitaxel: GEM-NABP) and repurposing All Trans Retinoic Acid (ATRA) to target the stroma may extend progression-free survival and enable successful surgical resection for patients with laPDAC, since data from phase IB clinical trial demonstrate safety of GEM-NABP-ATRA combination to patients with advanced PDAC with potential therapeutic benefit. Methods Patients with laPDAC will receive at least six cycles of GEM-NABP with 1:1 randomisation to receive this with or without ATRA to assess response, until progression or intolerance. Those with stable/responding disease may undergo surgical resection. Primary endpoint is progression free survival (PFS) defined as the time from the date of randomisation to the date of first documented tumour progression (response evaluation criteria in solid tumours [RECIST] v1.1) or death from any cause, whichever occurs first. Secondary endpoints include objective response rate (ORR), overall survival (OS), safety and tolerability, surgical resection rate, R0 surgical resection rate and patient reported outcome measures (PROMS) as measured by questionnaire EQ-5D-5L. Exploratory endpoints include a decrease or increase in CA19-9 and serum Vitamin A over time correlated with ORR, PFS, and OS. Discussion STARPAC2 aims to assess the role of stromal targeting in laPDAC. Trial registration EudraCT: 2019–004231-23; NCT04241276; ISRCTN11503604.https://doi.org/10.1186/s12885-024-13333-zLocally advanced pancreatic ductal adenocarcinoma (laPDAC)Gemcitabine and nab-paclitaxel (GEM-NABP)All-trans-retinoic acid (ATRA)ChemotherapyStromaProgression |
| spellingShingle | Hemant M. Kocher BCI-STARPAC2 team BPTB team Precision-Panc team Peter Sasieni Pippa Corrie Mairéad G. McNamara Debashis Sarker Fieke E. M. Froeling Alan Christie Roopinder Gillmore Khurum Khan David Propper Study protocol: multi-centre, randomised controlled clinical trial exploring stromal targeting in locally advanced pancreatic cancer; STARPAC2 BMC Cancer Locally advanced pancreatic ductal adenocarcinoma (laPDAC) Gemcitabine and nab-paclitaxel (GEM-NABP) All-trans-retinoic acid (ATRA) Chemotherapy Stroma Progression |
| title | Study protocol: multi-centre, randomised controlled clinical trial exploring stromal targeting in locally advanced pancreatic cancer; STARPAC2 |
| title_full | Study protocol: multi-centre, randomised controlled clinical trial exploring stromal targeting in locally advanced pancreatic cancer; STARPAC2 |
| title_fullStr | Study protocol: multi-centre, randomised controlled clinical trial exploring stromal targeting in locally advanced pancreatic cancer; STARPAC2 |
| title_full_unstemmed | Study protocol: multi-centre, randomised controlled clinical trial exploring stromal targeting in locally advanced pancreatic cancer; STARPAC2 |
| title_short | Study protocol: multi-centre, randomised controlled clinical trial exploring stromal targeting in locally advanced pancreatic cancer; STARPAC2 |
| title_sort | study protocol multi centre randomised controlled clinical trial exploring stromal targeting in locally advanced pancreatic cancer starpac2 |
| topic | Locally advanced pancreatic ductal adenocarcinoma (laPDAC) Gemcitabine and nab-paclitaxel (GEM-NABP) All-trans-retinoic acid (ATRA) Chemotherapy Stroma Progression |
| url | https://doi.org/10.1186/s12885-024-13333-z |
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