Clinical trial · Interventional
Preoperative Dose-dense Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel to Treat Patients With Locally Gastric Cancer
Preoperative Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel (Intensified PET) in Patients With Locally Gastric Cancer : a Phase II Proof-of-concept Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
If surgery remains the main treatment for gastric cancer without distant metastases; perioperative-chemotherapy increased the likelihood of progression free survival. Perioperative chemotherapy appears to have many advantages : to reduce the tumor volume, to improve the R0 resection rate, and to act on micro-metastases. Therefore, peri-operative chemotherapy combining cisplatin, epirubicin and 5-Fluorouracile is a validated strategy to treat gastric cancer. However, several pitfalls remained. Particularly, only 42% of patients could received post-chemotherapy, due to post-operative complications and toxicities. To overcome this limitation, the investigators will conduct a phase II clinical trial assessing the clinical interest of a dose-dense preoperative chemotherapy combining cisplatin (P), epirubicin (E) and paclitaxel (T). The increasing evidence of taxane's role in gastric cancer treatment, as well as the biological synergisms reported in paclitaxel/cisplatin and paclitaxel/epirubicin combinations, sustain the development of dose density based on PET combination in gastric carcinoma. The aim of the IPEC-GC study is to evaluate the effectiveness of this PET preoperative regimen
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lower Oesophagus Cancer | — | UNRESOLVED | — |
| Oesophageal Junction Cancer | — | UNRESOLVED | — |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| gastric surgery | Procedure | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET regimen
- interventionNames
- Drug: Epirubicin
- Drug: Cisplatin
- Drug: Paclitaxel
- Procedure: gastric surgery
Primary outcomes (1)
- measure
- curative resection rate
- timeFrame
- an expected average of 4 weeks after surgery
Secondary outcomes (5)
- measure
- response rate
- timeFrame
- between 2 and 4 weeks after the end of the last cycle of chemotherapy
- description
- Response rate will be evaluated using RECIST v1.1 criteria (Response Evaluation Criteria in Solid Tumors ; Eisenhauer et al, 2009) by a CT-scan done between 2 and 4 weeks after the end of the last cycle to verify the absence of local or distant progression before surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion criteria : * Age \> 18 and \< 70 years (male and female) * surgical resectability * ECOG performance status ≤ 1 * ASA score \< 3 (appreciation by a surgeon) * BMI \< 30 if an upper oesogastrectomy is required * no previous cytotoxic chemotherapy * ejection fraction \> 50% in echocardiography before start of therapy * written informed consent Non-inclusion criteria : * distant metastases or infiltration of adjacent structures or organs and all primarily not resectable stages * relapse * hypersensitivity against Paclitaxel, Epirubicin or Cisplatin * malignant secondary disease, dated back \< 5 years (exception: in situ carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma) * peripheral polyneuropathy * diabetes complicated by coronary artery disease or vasculopathy * Severe respiratory insufficiency * patient with weight loss \> 10% * pregnancy or lactation * inclusion in another trial * patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.
References
Publications (1)
- RESULTJary M, Ghiringhelli F, Jacquin M, Fein F, Nguyen T, Cleau D, Nerich V, El Gani M, Mathieu P, Valmary-Degano S, Arnould L, Lassabe C, Lamfichekh N, Fratte S, Paget-Bailly S, Bonnetain F, Borg C, Kim S. Phase II multicentre study of efficacy and feasibility of dose-intensified preoperative weekly cisplatin, epirubicin, and paclitaxel (PET) in resectable gastroesophageal cancer. Cancer Chemother Pharmacol. 2014 Jul;74(1):141-50. doi: 10.1007/s00280-014-2482-0. Epub 2014 May 14. PMID 24824852