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Neo-adjuvant Chemo + Peritonectomy + Hyperthermic Intraperitoneal Chemo in Peritoneal Carcinomatosis From Gastric Cancer

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ClinicalTrials.gov Identifier: NCT01379482
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Brief Summary:
The aims of this study are to investigate whether multimodal treatment of peritoneal carcinomatosis from gastric cancer is feasible and to evaluate the clinical outcomes and clinical effectiveness of neoadjuvant systemic chemotherapy followed by cytoreductive surgery + hyperthermic intraperitoneal chemotherapy + early postoperative intraperitoneal chemotherapy, as compared to systemic chemotherapy only, in patients with peritoneal carcinomatosis from gastric cancer.

Condition or disease Intervention/treatment Phase
Peritoneal Carcinomatosis Gastric Cancer Drug: Multimodal treatment Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Patients With Peritoneal Carcinomatosis From Gastric Cancer Treated With Preoperative Systemic Chemotherapy Followed by Peritonectomy and Intraperitoneal Chemotherapy
Study Start Date : January 2005
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multimodal treatment
Neoadjuvant systemic chemotherapy followed by cytoreductive surgery, hyperthermic intraperitoneal chemotherapy and early postoperative intraperitoneal chemotherapy
Drug: Multimodal treatment

3 months (range 2-4.5) with neoadjuvant systemic chemotherapy. Four weeks after receiving the last course of chemotherapy, patients will undergo laparotomy with the objective of performing cytoreduction + hyperthermic intraperitoneal chemotherapy.

Early peritoneal chemotherapy though intrabdominal drains for the first five postoperative days.

Neo-adjuvant chemotherapy:

Irinotecan+Nordic FLv (6 pat.) EOX (6 pat.) FLOX (3 pat.) Docetaxel+Irinotecan+5-FU+LV (1 pat.) FOLFIRI (1 pat.) ECF (1 pat.)

Hyperthermic intraoperative chemotherapy:

Cisplatin+doxorubicin (5 pat.). Oxaliplatin +concomitant i.v. 5-FU+ i.v. LV (3 pat.)

Early postoperative chemotherapy:

5-FU + i.v. LV (5 pat.) Paclitaxel (1 pat.)

Other Names:
  • Irinotecan+Nordic FLv (6 pat.)
  • EOX (6 pat.)
  • FLOX (3 pat.)
  • Docetaxel+Irinotecan+5-FU+LV (1 pat.)
  • FOLFIRI (1 pat.)
  • ECF (1 pat.)
  • Cisplatin+doxorubicin (5 pat.).
  • Oxaliplatin +concomitant i.v. 5-FU+ i.v. LV (3 pat.)
  • 5-FU + i.v. LV (5 pat.)
  • Paclitaxel (1 pat.)




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Jan 2005 until Mars 2009 ]


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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of primary gastric cancer + histologically and/or radiologically confirmed peritoneal carcinomatosis diagnosis
  • Adequate renal-, hematopoietic- and liver functions
  • WHO performance status (WHO) of < 2.

Exclusion Criteria:

  • Distant metastases
  • Surgically not resectable lymph-node metastasis
  • Contraindication to chemotherapy treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379482


Locations
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Sweden
Uppsala University
Uppsala, Sweden
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Haile Mahteme, Ass prof Uppsala University, Sweden

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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01379482     History of Changes
Other Study ID Numbers: 2007/073
43145 ( Other Grant/Funding Number: Uppsala University sådd-ALF )
First Posted: June 23, 2011    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2011
Keywords provided by Uppsala University:
Peritoneal carcinomatosis from gastric cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Carcinoma
Peritoneal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Peritoneal Diseases
Paclitaxel
Docetaxel
Cisplatin
Oxaliplatin
Doxorubicin
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors