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Neoadjuvant systemic chemotherapy followed by cytoreductive surgery, hyperthermic intraperitoneal chemotherapy and early postoperative intraperitoneal chemotherapy

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.)

Multimodal treatment

Haile Mahteme, Ass prof

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.

Between January 2005 and March 2009, 18 consecutive patients with PC from gastric cancer were scheduled for neoadjuvant systemic chemotherapy followed by CRS+HIPEC+EPIC at Uppsala University Hospital, Uppsala, Sweden. The regional ethics committee approved the study and informed consent was obtained from each patient and the study was registered in ClinicalTrials.gov, with identifier NCT01379482. The eligibility requirements for treatment were: histologically confirmed diagnosis of primary gastric adenocarcinoma; histologically and radiologically confirmed PC diagnosis; no distant metastases; adequate renal, haematopoietic and liver functions, and Karnofsky performance status (KPS) of \> 70. Table 1 summarises demographic and basic clinical patient data.

Patients Eighteen patients (eight female and ten male), with a median age of 57 years (range 38-74), were included in the study. Treatment began with three months' (range 2-4.5) neoadjuvant systemic chemotherapy. Four weeks after receiving the last course of chemotherapy, patients with no clinical and radiological signs of tumour progression underwent laparotomy in preparation for CRS+HIPEC followed by EPIC for five days. Patients with clinical and radiological signs of tumour progression during the neoadjuvant systemic chemotherapy did not undergo the planned loco-regional treatment but continued with palliative systemic chemotherapy at the discretion of the physician in charge of the patient.

Neoadjuvant chemotherapy The intention was to treat the patients with combination chemotherapy for three months. The choice of chemotherapy was individualised, but all patients received optimal drug combinations suitable for good performance patients with metastatic gastric cancer.

Routine clinical controls and blood sampling were done before every treatment cycle. In order to rule out patients with progressive disease and distant metastasis, abdominal and thoracic CT scan evaluations were performed prior to surgery.

Surgical treatment Depending on disease extent, CRS was performed as described by Sugarbaker. Immediately postoperatively, tumour load and completeness of cytoreduction for PC were recorded using the Peritoneal Cancer Index (PCI) \[12\] and Completeness of Cytoreduction scores (CC) respectively. The PCI (range 1-39) consists of lesion size scores in 13 different regions of the abdomen: 0=no tumour seen, 1=tumour up to 0.5 cm, 2=tumour up to 5 cm and 3=tumour\>5 cm. The PCI score is calculated by adding together the lesion size scores for the 13 regions. The CC score is based upon the size of tumour left after cytoreduction: CC0=no peritoneal seeding visible, CC1=nodules up to 2.5 mm, CC2=nodules up to 2.5 cm and CC3=nodules\>2.5 cm.

HIPEC and EPIC HIPEC was administered according to the Coliseum technique and was combined with EPIC for five days. Before perfusion, the patient's body temperature was lowered to 35°C with a cooling blanket (Allon®). The intra-abdominal temperature during perfusion ranged from 42°C to 44°C. Four intra-abdominal drains were left in place after surgery and EPIC was given daily during the first five postoperative days.

Tumour markers, histopathology and adverse events Five serum tumour markers (CEA, CA 125, CA 19-9, CA 15-3 and CA 72-4) were taken one to six days before surgery and ten days after surgery, to analyse the frequency of the impact of gastric cancer with PC on these tumour markers.

The sixth edition of the TNM classification was used. The presence of signet ring cells and the grade of differentiation according to Lauren's classification were reported.

Therapy-related adverse events were graded according to the National Cancer Institute's common toxicity criteria (NCI-CTC) version 3.0. OS was calculated for all patients from the date of the first neoadjuvant chemotherapy.

Statistical methods All analyses were performed on the basis of intention-to-treat. OS and disease-free survival (DFS) were analysed for patients treated with CC0. Results were presented as the median, with a 95% confidence interval (CI). A P-value of less than 0.05 was considered statistically significant. The computer software package STATISTICA AXA version 10.0, StatSoft Scandinavia, Sweden, was used for statistical evaluation of the survival data.

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

Uppsala University

Nutritional and Metabolic Diseases

Adenocarcinoma

Malnutrition

Wasting Syndrome

Cachexia

Syndrome

Nutrition Disorders

Body Weight

Weight Loss

Body Weight Changes

Thinness

Metabolic Diseases

Evaluation of the nutritional status and body composition on tumor regression grade in gastric cancer patients scheduled for multimodal treatment. Nutritional status assessment will include: selected clinical variables evaluation (weight, BMI, nutritional status scales), bioelectrical impedance analysis and selected laboratory parameter assessment. After inclusion in the study, each patient will have four consecutive nutritional status assessments: (1) one day prior staging laparoscopy or during qualification to neoadjuvant chemotherapy, (2) one day before the gastrectomy, (3) one month after the gastrectomy, (4) after the last cycle of adjuvant chemotherapy.

Observational Survey

Zuzanna Pelc, PhD

Karol Rawicz-Pruszyński, Professor

Karol RawiczPruszyński, Professor

The aim of this single-arm prospective, multicenter, cross-sectional study is to evaluate the nutritional status and body composition on tumor regression grade with bioelectrical impedance analysis in gastric cancer patients undergoing multimodal treatment. Results of this study will reveal whether nutritional status and body composition assessment based on bioelectrical impedance analysis will become a validated and objective tool to support clinical decisions in gastric cancer patients undergoing multimodal treatment.

Up to 20% of gastric cancer patients experience unintentional loss of their pretreatment body weight. Malnutrition contributes to increased morbidity, higher risk of perioperative complications and systemic toxicity. A standardized approach to evaluate the nutritional status of gastric cancer patients is yet to be established. Bioelectrical impedance analysis is a non-invasive technique estimating changes in body composition over time.

125 patients with locally advanced gastric adenocarcinoma scheduled for multimodal treatment will be included in the study. Four consecutive nutritional status assessments will be performed throughout the treatment.

MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment

MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment - MOONRISE Study

determined using the Becker criteria (1- complete response, 2 - good response, 3 - partial response, 4 - no response)

evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0)

Assessed by the Comprehensive Complication Index (CCI). Min-Max values (0-100), higher scores mean a worse outcome

Overall survival analysis will determine whether bioelectrical impedance analysis is a prognostic factor in advanced gastric cancer patients

Assessment based on The European Organization for Research and Treatment of Cancer quality of life, gastric-cancer specific questionnaire(EORTC QLQ - STO22). Min-Max value (1-7); higher scores mean a better outcome

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neo-adjuvant Chemo + Peritonectomy + Hyperthermic Intraperitoneal Chemo in Peritoneal Carcinomatosis From Gastric Cancer	NCT01379482	Peritoneal Carc... Gastric Cancer	Multimodal trea...	- 80 Years	Uppsala University
MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment	NCT05723718	Gastric Cancer Gastric Adenoca... Malnutrition Cachexia	Observational S...	18 Years - 100 Years	Medical University of Lublin

Spots Global Cancer Trial Database for multimodal treatment