Clinical trial · Interventional
Neoadjuvant Therapy for the Treatment of Gastroesophageal Junction and Gastric Cancers
Total Neoadjuvant Therapy for the Treatment of Gastroesophageal Junction (GEJ) and Gastric Cancers: A Pilot Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI Decision
Summary
Brief summary (as posted)
This phase I trial tests the safety, side effects studies chemotherapy followed by chemotherapy at the same time as radiation therapy (chemoradiation) before surgery (neoadjuvant) in treating patients with stage gastric (stomach) or gastroesophageal junction cancer . Chemotherapy drugs, such as docetaxel, oxaliplatin , leucovorin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy and chemoradiation before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.
Conditions
Conditions (25)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Stage I Gastric Cancer AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IIA Gastric Cancer AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IIB Gastric Cancer AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage II Gastric Cancer AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage III Gastric Cancer AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Surgical Procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy, chemoradiation, surgery)
- description
- NEOADJUVANT CHEMOTHERAPY: Patients receive FLOT chemotherapy consisting of docetaxel intravenously (IV) , oxaliplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on day 1 or FOLFOX chemotherapy consisting of oxaliplatin IV and leucovorin IV, and fluorouracil IV continuously over 24 hours on days 1 and 2. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. NEOADJUVANT CHEMORADIATION: Within 4 weeks after completing neoadjuvant chemotherapy, patients undergo radiation therapy in 25 fractions over 5 weeks. Patients also receive either fluorouracil IV continuously for 24 hours on days 1-5 or capecitabine orally (PO) twice daily (BID) on days 1-5. Cycles repeat weekly for 5 weeks in the absence of disease progression or unacceptable toxicity. SURGERY: Within 4-8 weeks after neoadjuvant chemoradiation, patients undergo surgical resection according to tumor location and per surgeon expertise.
- interventionNames
- Drug: Capecitabine
- Drug: Docetaxel
- Drug: Fluorouracil
- Drug: Leucovorin
- Drug: Oxaliplatin
- Radiation: Radiation Therapy
- Procedure: Surgical Procedure
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically proven, cT2N0-T4aN3M0 (TNM 8th edition), gastric or Siewert II-III GEJ adenocarcinoma * Evaluation with endoscopic ultrasound (EUS) and staging laparoscopy prior to enrollment is strongly recommended. * Patient should be a candidate for neoadjuvant chemotherapy with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) or fluorouracil and oxaliplatin (FOLFOX). * Patients should be \>= 18 years old * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Patient should be eligible for surgical intervention * T1 N0 disease (assessed by endoscopic ultrasound) Exclusion Criteria: * Evidence of distant metastatic disease * Solitary functioning kidney within the potential radiation field * Peripheral polyneuropathy \> National Cancer Institute (NCI) grade II
References
Publications (0)
Data not yet available