Gastric Cancer, Peritoneal Carcinomatosis
Conditions
Brief summary
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
Detailed description
The gastric carcinoma is one of the four most common tumors occurring worldwide. The advanced phase is characterized by metastasis and poses a very poor prognosis for survival. In 20%-30% of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to metastases in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis and its five-year survival rate is less than 2%. Even after R0 resection of a localized gastric carcinoma the five-year survival rate is only 40%, not least of all because relapses in the form of peritoneal metastases are a common occurrence. Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which stands in strong contrast to the 40% risk for patients with negative cytology. In the study presented here (group A) therapeutic hyperthermic intraperitoneal chemoperfusion (HIPEC, in the literature also known as HIIC (heated intraoperative intraperitoneal chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c and cisplatin will be administered following gastrectomy in patients with a gastric carcinoma with free tumor cells in cytology diagnosed in the preoperative laparoscopy in comparison to (group B) solely gastrectomy in patients with a gastric carcinoma and also with free tumor cells diagnosed in cytology in the preoperative laparoscopy. A randomization will be performed between group A and B. Patients with gastric carcinoma (TNM Stage ≥ T2\<T4) without proven metastases (TNM stage M0), with and without involved regional lymph nodes (TNM stage +N/-N) and positive cytology in preoperative abdominal lavage will be included. Exclusion criteria are extended disease or inoperable tumor. This study is already permitted by the local ethic commission and the German Federal Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code: HIPEC\_Stomach) and was initiated in August 2012.
Interventions
DRUGpositive cytology with HIPEC
HIPEC with mytomycin and cisplatin
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically proven gastric adenocarcinoma: uT1,uT2, uT3, Nx, M0 2. No prior chemotherapy 3. Patients of full age, independent of gender ECOG ≤ 2 4. No dissemination of the tumor confirmed by CT of the lung and the abdomen. 5. Signed Consent form of the Patient agreeing to investigations 6. Leucocytes \> 3.000/µl 7. Thrombocytes \> 100.000/µl 8. Creatinine ≤ 1.5mg/dl and or Clearance \> 60 ml/min 9. informed consent of the patient 10. normal ejection-fraction of the heart
Exclusion criteria
1. Dissemination of the tumor or non-resectable primary tumor 2. Malignant secondary disease \< 5 years in the past (Exception: in-situ-carcinoma of the cervix and appropriately treated basal cell carcinoma of the skin) 3. Patient not of full age 4. Inflammatory chronic bowel disease 5. Inclusion of the patient in a different study 6. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peritoneal Carcinosis Free Survival | 5 Years | Three patients were enrolled in the study. No study results because no patient has received study drug. |
| Disease Free Survival | 5 years | No study results because no patient has received study drug. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Procedure Related Complication | 60 days | No study results because no patient has received study drug. |
| Kinetics of Mitomycin and Cisplatin | 24 hours after application | — |
Countries
Germany
Participant flow
Recruitment details
Study was early terminated due to recruitment problem. All active patient have study
Participants by arm
| Arm | Count |
|---|---|
| Positive Cytology With HIPEC gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative positive cytology with HIPEC: HIPEC with mytomycin and cisplatin | 0 |
| Positive Cytology no HIPEC gastric cancer cytology positive without HIPEC | 0 |
| Negative Cytology Without HIPEC gastric cancer with negative cytology | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | Positive Cytology no HIPEC | Negative Cytology Without HIPEC | Total | Positive Cytology With HIPEC |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 | 0 | 0 | 0 |
| Age, Categorical >=65 years | — | — | 0 | — |
| Age, Categorical Between 18 and 65 years | — | — | 0 | — |
| Sex: Female, Male Female | 0 | 0 | — | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Disease Free Survival
No study results because no patient has received study drug.
Time frame: 5 years
Primary
Peritoneal Carcinosis Free Survival
Three patients were enrolled in the study. No study results because no patient has received study drug.
Time frame: 5 Years
Population: No study results because no patient has received study drug. Patient in the intervention group withdrawal of consent before intervention.
Other Pre-specified
Kinetics of Mitomycin and Cisplatin
Time frame: 24 hours after application
Other Pre-specified
Procedure Related Complication
No study results because no patient has received study drug.
Time frame: 60 days