Neo-adjuvant Chemo + Peritonectomy + Hyperthermic Intraperitoneal Chemo in Peritoneal Carcinomatosis From Gastric Cancer
Phase II Study of Patients With Peritoneal Carcinomatosis From Gastric Cancer Treated With Preoperative Systemic Chemotherapy Followed by Peritonectomy and Intraperitoneal Chemotherapy
2 other identifiers
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2005
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 7, 2011
CompletedFirst Posted
Study publicly available on registry
June 23, 2011
CompletedMay 6, 2014
May 1, 2011
4.2 years
June 7, 2011
May 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Jan 2005 until Mars 2009
Study Arms (1)
Multimodal treatment
EXPERIMENTALNeoadjuvant systemic chemotherapy followed by cytoreductive surgery, hyperthermic intraperitoneal chemotherapy and early postoperative intraperitoneal chemotherapy
Interventions
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.)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Distant metastases
- Surgically not resectable lymph-node metastasis
- Contraindication to chemotherapy treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uppsala University
Uppsala, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haile Mahteme, Ass prof
Uppsala University, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2011
First Posted
June 23, 2011
Study Start
January 1, 2005
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
May 6, 2014
Record last verified: 2011-05