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Efficacy of hyperth...
Efficacy of hyperthermic intraperitoneal chemotherapy in colorectal cancer : A phase I and III open label randomized controlled registry-based clinical trial protocol
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- Ghanipour, Lana (författare)
- Uppsala University,Uppsala universitet,Gastrointestinalkirurgi,Uppsala Univ Hosp, Uppsala, Sweden,Uppsala University Hospital
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- Jansson Palmer, Gabriella (författare)
- Karolinska Institutet,Karolinska Univ Hosp, Dept Pelv Canc, GI Oncol & Colorectal Surg Unit, Stockholm, Sweden.
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- Nilsson, Per J. (författare)
- Karolinska Institutet,Karolinska Univ Hosp, Dept Pelv Canc, GI Oncol & Colorectal Surg Unit, Stockholm, Sweden.
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- Nordenvall, Caroline (författare)
- Karolinska Institutet,Karolinska Univ Hosp, Dept Pelv Canc, GI Oncol & Colorectal Surg Unit, Stockholm, Sweden.
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- Frödin, Jan-Erik (författare)
- Karolinska Institutet
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- Bexe Lindskog, Elinor (författare)
- Sahlgrens Univ Hosp, Inst Clin Sci, Dept Surg, Gothenburg, Sweden.,Sahlgrenska University Hospital
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- Asplund, Dan (författare)
- Sahlgrens Univ Hosp, Inst Clin Sci, Dept Surg, Gothenburg, Sweden.,Sahlgrenska University Hospital
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- Swartling, Torbjörn (författare)
- Sahlgrens Univ Hosp, Inst Clin Sci, Dept Surg, Gothenburg, Sweden.,Sahlgrenska University Hospital
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- Graf, Wilhelm (författare)
- Uppsala University,Uppsala universitet,Gastrointestinalkirurgi,Uppsala Univ Hosp, Uppsala, Sweden,Uppsala University Hospital
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- Birgisson, Helgi (författare)
- Uppsala University,Uppsala universitet,Gastrointestinalkirurgi,Uppsala Univ Hosp, Uppsala, Sweden,Uppsala University Hospital
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- Syk, Ingvar (författare)
- Lund University,Lunds universitet,Kirurgi,Forskargrupper vid Lunds universitet,Surgery,Lund University Research Groups,Lund Univ, Skane Univ Hosp, Dept Clin Sci, Malmö, Sweden.
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- Verwaal, Victor (författare)
- Lund University,Lunds universitet,Kirurgi,Forskargrupper vid Lunds universitet,Surgery,Lund University Research Groups,Lund Univ, Skane Univ Hosp, Dept Clin Sci, Malmö, Sweden.
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- Brändstedt, Jenny (författare)
- Lund University,Lunds universitet,Kirurgi,Forskargrupper vid Lunds universitet,Surgery,Lund University Research Groups,Lund Univ, Skane Univ Hosp, Dept Clin Sci, Malmö, Sweden.
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- Cashin, Peter H., 1984- (författare)
- Uppsala University,Uppsala universitet,Gastrointestinalkirurgi,Uppsala Univ Hosp, Uppsala, Sweden,Uppsala University Hospital
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D'Acapito, F (författare)
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(creator_code:org_t)
- Public Library of Science (PLoS), 2024
- 2024
- Engelska.
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Ingår i: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 19:3
- Relaterad länk:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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http://dx.doi.org/10... (free)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://lup.lub.lu.s...
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http://kipublication...
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http://kipublication...
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Abstract
Ämnesord
Stäng
- Standard treatment for patient with peritoneal metastases from colorectal cancer is cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). In recent years, the efficacy of oxaliplatin-based HIPEC has been challenged. An intensified HIPEC (oxaliplatin+irinotecan) in combination with early postoperative intraperitoneal chemotherapy (EPIC) has shown increased recurrence-free survival in retrospective studies. The aim of this trial is to develop a new HIPEC/EPIC regimen and evaluate its effect on morbidity, oncological outcome, and quality-of-life (QoL). This study is designed as a combined phase I/III multicenter randomized trial (RCT) of patients with peritoneal metastases from colorectal cancer eligible for CRS-HIPEC. An initial phase I dose escalation study, designed as a 3+3 stepwise escalation, will determine the maximum tolerable dose of 5-Fluorouracil (5-FU) as 1-day EPIC, enrolling a total of 15–30 patients in 5 dose levels. In the phase III efficacy study, patients are randomly assigned intraoperatively to either the standard treatment with oxaliplatin HIPEC (control arm) or oxaliplatin/irinotecan-HIPEC in combination with single dose of 1-day 5-FU EPIC (experimental arm). 5-FU is administered intraoperatively after CRS-HIPEC and closure of the abdomen. The primary endpoint is 12-month recurrence-free survival. Secondary endpoints include 5-year overall survival, 5-year recurrence-free survival (registry based), postoperative complications, and QoL up to 3 years after study treatment. This phase I/III trial aims to identify a more effective treatment of colorectal peritoneal metastases by combination of HIPEC and EPIC.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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- Av författaren/redakt...
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Ghanipour, Lana
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Jansson Palmer, ...
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Nilsson, Per J.
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Nordenvall, Caro ...
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Frödin, Jan-Erik
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Bexe Lindskog, E ...
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visa fler...
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Asplund, Dan
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Swartling, Torbj ...
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Graf, Wilhelm
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Birgisson, Helgi
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Syk, Ingvar
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Verwaal, Victor
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Brändstedt, Jenn ...
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Cashin, Peter H. ...
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D'Acapito, F
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- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Kirurgi
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Cancer och onkol ...
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PLOS ONE
- Av lärosätet
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Uppsala universitet
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Lunds universitet
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Karolinska Institutet