Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this clinical trial, patients with gastric and gastroesophageal junction adenocarcinoma will be included. Treatment with curative intent will be given with chemotherapy for 4 cycles with fluorouracil, oxaliplatin and irinotecan preoperatively followed by surgery, and then additionally 4 cycles of the same chemotherapy postoperatively. The standard treatment today is preoperative treatment with fluorouracil and oxaliplatin pre-and postoperatively. The rationale for this trial is, that the addition of irinotecan might improve treatments results.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with chemotherapy pre- and postoperative. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorouracil | Drug | Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the rate of histopathological response according to Becker criteria. | Assessment of histopathological response, ypTNM, resection margin and residual tumor status. If Laurén classification and mismatch repair (MMR) or microsatelite instability status (MSI) could not be assessed on pretreatment biopsies it should be assessed on the resected specimen. Results do not have to be awaited before start of chemotherapy. | After surgery. |
Not provided
Not provided
Inclusion Criteria:
Histologically verified, resectable gastric or gastroesophageal (GE) (gastroesophageal) junction (Siewert type I-III) adenocarcinoma Confirmation of patient operability by surgeon
Primary tumor, regional nodes, metastasis (TNM), 8th edition): cT2-4a or cN+, cM0
Age: 18 years or older
World Health Organization (WHO) performance status ≤ 1
Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy
Adequate laboratory findings:
Fertile men and women must use highly effective means of contraception (failure rate <1%) such as:
Signed written informed consent
The patient must be able to comply with the protocol
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital, Ullevål Hospital | Oslo | 0450 | Norway | |||
| Lund University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oxaliplatin | Drug | Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles. |
|
| Irinotecan | Drug | Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles. |
|
| Lund |
| 221 85 |
| Sweden |
| Karolinska University Hospital | Stockholm | 141 86 | Sweden |
| Centrallasarettet i Växjö | Vaxjo | 352 34 | Sweden |
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
Not provided
Not provided