Clinical trial · Interventional
Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer
A Phase II Trial of Postoperative Chemotherapy and Chemo-radiotherapy for Resected Adenocarcinoma of the Stomach and Gastro-esophageal Junction
NCT00718913CI-TRIAL-00017935completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study will determine the feasibility of adjuvant chemotherapy and chemo-radiotherapy for patients with surgically resected adenocarcinoma of the stomach and gastro-esophageal junction.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- TCX -\>RT -\> TCX
- interventionNames
- Drug: Docetaxel
- Drug: Cisplatin
- Drug: Capecitabine
- Radiation: Radiation
Primary outcomes (1)
- measure
- The proportion of patients completing protocol therapy (feasibility)
- timeFrame
- The feasibility will be defined as the proportion of patients who receive adjuvant chemotherapy and chemo-radiation over total registered
Secondary outcomes (3)
- measure
- Toxicity profile
- timeFrame
- Toxicity assessment on each cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with radically resected adenocarcinoma of the stomach and/or gastroesophageal junction with histologic proof of adenocarcinoma, pathologically staged T2-3, any N, M0 * No prior radiation therapy to the stomach or immunotherapy or chemotherapy for any reason * Patients must have a life expectancy of at least 16 weeks and a performance status of \< 2 ECOG scale * Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen. Patients who relapse within the first 6 months after the completion of adjuvant treatment are not eligible for the study. * Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of \> 2.000/µL, and platelet count of \> 100.000/µL), adequate liver function (bilirubin \< 1,5 mg/dl), and adequate renal function (creatinine \< 1,5 mg/dl * Patients must be able to understand the nature of this study and give written informed consent Exclusion Criteria: * Patients with T1N0 carcinoma * Positive cytology of pleural, or pericardial effusion or patients with any peritoneal disease diagnosed intra-operatively) * Biopsy proof of lymph node metastases outside the study field such as supraclavicular, mediastinal, or para-aortic nodes * Evidence of metastatic disease to distant organs * Patients with cardiac disease graded as New York Heart Association Class III or IV, severe uncontrolled diabetes, hypertension, cerebron-vascular disease, or infection * Patients with diabetic neuropathy * Abnormalities of mental status such that either the patient cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements * Presence of concurrent or previous malignancies in the past 5 years (except for resected squamous or basal cell carcinoma of the skin) * Pregnant women are excluded from study entry due to the teratogenic effects of the study treatment
References
Publications (0)
Data not yet available
No reference posted for this study.