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van CCT (UK)

van CCT (UK)

Treatment of peritoneal metastases in stomach cancer patients with extensive surgery and heated intraperitoneal chemotherapy

- candidate number15668
- NTR NumberNTR4250
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-nov-2013
- Secondary IDsNL42799.031.13 Toetsingonline
- Public TitleTreatment of peritoneal metastases in stomach cancer patients with extensive surgery and heated intraperitoneal chemotherapy
- Scientific TitleTreatment of PERItoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy
- hypothesisIn patients with limited peritoneal dissemination of stomach cancer, following neoadjuvant chemotherapy, cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy with oxaliplatin and docetaxel is a feasible option.
- Healt Condition(s) or Problem(s) studiedHIPEC, Gastric carcinoma, Cytoreductive surgery, Hyperthermia
- Inclusion criteria• Biopsy proven adenocarcinoma of the stomach (including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach for which the intended surgical treatment is a gastric resection, and not a resection of the oesophagus and cardia)
• T3-T4 tumour based upon CT-scan and/or EUS results
• Tumour positive peritoneal cytology and/or peritoneal carcinomatosis limited to the upper abdominal cavity (above the transverse colon) and/or at the most at one location in the lower abdominal cavity (e.g., Douglas’ pouch, ovarian metastasis, Sister Mary Joseph nodule) confirmed by diagnostic laparoscopy
• Age ≥ 18 years
• WHO performance status 0-1
• ASA classification I-III
• Adequate bone marrow, hepatic and renal function, i.e., minimal acceptable laboratory values at start of the study inclusion:
a. ANC ≥ 1.5 x 109 /L
b. Platelet count ≥ 100 x 109 /L
c. Serum bilirubin ≤ 1.5 x ULN, and ALAT and ASAT ≤ 2.5 x ULN
d. Creatinine clearance ≥ 50 ml/min (measured or calculated by Cockcroft-Gault formula).
• Wildtype for DPD*2A
• Negative pregnancy test (urine/serum) for female patients of childbearing potential
• Life expectancy ≥ 3 months, allowing adequate follow-up
• Able and willing to undergo blood sampling for pharmacokinetics
• Written informed consent
- Exclusion criteria• Distant metastases (e.g., liver, lung, para-aortic lymph nodes) or small bowel dissemination
• Signs of local irresectability
• Recurrent gastric cancer
• Metachronous peritoneal carcinomatosis
• Prior treatment of gastric cancer with systemic anticancer therapy
• Pregnancy, breast feeding or active pregnancy ambition
• Unreliable contraceptive methods. Patients enrolled in this study must agree to use a reliable contraceptive method throughout the study
• Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type
• A known history of hepatitis B or C with active viral replication
• Recent myocardial infarction (< 6 months) or unstable angina
• Uncontrolled diabetes mellitus
• Any medical condition not yet specified above that is considered to possibly, probably or definitely interfere with study procedures, including adequate follow-up and compliance and/or would jeopardize safe treatment
• Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate1-jan-2019
- Target number of participants30
- InterventionsNeoadjuvant treatment
Eligible patients will be scheduled for neoadjuvant systemic chemotherapy involving 3 cycles of docetaxel, oxaliplatin and capecitabine (DOC) - plus trastuzumab in case of a HER2-positive tumour (T-DOC) - at three-weekly intervals.

Surgical procedure
In absence of progressive disease, assessed by CT-scan after the second neoadjuvant chemotherapeutic course, surgery will be planned 3-6 weeks after the last course of chemotherapy. At laparotomy, the presence and extent of peritoneal tumour deposits will be recorded. Any peritoneal fluid is sampled for cytology. When a potentially radical resection of the primary tumour can be achieved, a total or partial gastrectomy with a D2 lymph node dissection is performed. In patients with limited peritoneal carcinomatosis, cytoreductive surgery (CRS) is done with the objective to leave no macroscopic tumour behind.

HIPEC procedure
Intraperitoneal chemoperfusion is performed using an open HIPEC technique. At an intraperitoneal temperature of 41-42 °C, 460 mg/m2 oxaliplatin is added to the perfusate. After 30 minutes, the perfusion fluid is drained from the abdomen. In successive patients a dose-escalation study will be performed with 0-50-75-100-125-150 mg/m2 docetaxel in the peritoneal cavity for 90 minutes.
- Primary outcomeTreatment related toxicity (graded according to the NCI Common Toxicity Criteria version 4.0)
- Secondary outcome- postoperative morbidity and mortality
- completion of the study protocol
- pharmacokinetic parameters
- cytoreductive completeness score
- peritoneal cancer index
- patterns of tumour recurrence
- disease free and overall survival
- TimepointsToxicity will be scored following 30 days after cytoreductive surgery and HIPEC, according to the CTC-criteria.
Patterns of tumour recurrence and disease free and overall survival will be measured up to 2 years after cytoreductive surgery and HIPEC.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL) , Sint Antonius Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
Investigator initiated trial ( IIT )
- PublicationsN/A
- Brief summaryThis is a Dutch two center, open label, dose-escalation phase I-II study aimed to evaluate the safety, tolerability and feasibility of HIPEC with oxaliplatin and docetaxel after neoadjuvant systemic chemotherapy with DOC or T-DOC in advanced gastric cancer patients with tumour positive peritoneal cytology (C+) and/or limited peritoneal carcinomatosis (P+). This will be accomplished by enrolling 20-30 patients meeting the inclusion criteria, using a 3+3 design. Safety will be assessed by toxicity graded according to the NCI Common Toxicity Criteria version 4.0.
- Main changes (audit trail)
- RECORD6-nov-2013 - 13-jan-2014

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