Last reviewed · How we verify
A Pilot Study of FOLFIRINOX in Combination With Neoadjuvant Radiation for Gastric and GE Junction Cancers
Phase 1 trial testing Irinotecan in GastroEsophageal Cancer in 25 participants. Completed in 29 February 2024.
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 24 October 2017 |
| Primary completion | 26 September 2018 |
| Estimated completion | 29 February 2024 |
| Sites | 1 location across United States |
Massachusetts General Hospital
18 and older, any sex, with GastroEsophageal Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The number of participants that complete the assigned study intervention.
| Group | Value | 95% CI |
|---|---|---|
| FOLFIRINOX + pre-operative radiation | 23 |
The number of participants that experienced at least one treatment related adverse event as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4.0).
| Group | Value | 95% CI |
|---|---|---|
| FOLFIRINOX + pre-operative radiation | 25 |
The number of participants that achieved a clinical response following treatment. Clinical response is defined as achieving a best overall response of a complete response (CR) or a partial response (PR). * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
| Group | Value | 95% CI |
|---|---|---|
| FOLFIRINOX + pre-operative radiation | 20 |
The number of participants that achieve a pathologic complete response at surgery following FOLFIRINOX and chemoradiation. All patients will undergo a full pathological review of their surgical specimen according to the American Joint Committee on Cancer (AJCC) Staging Classification, 6th edition. Initial gross evaluation and identification of resection margins will be performed jointly by the surgeon and the pathologist. Pathological complete response will be defined as the absence of any viable tumor cells within the pathologic specimen.
| Group | Value | 95% CI |
|---|---|---|
| FOLFIRINOX + pre-operative radiation | 7 |
Time frame: From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | FOLFIRINOX + pre-operative… |
|---|---|---|
| Lymphopenia/Leukopenia/Neutropenia | Blood and lymphatic system disorders | — |
| Hypokalemia/Hyponatremia/Hypocalcemia | Metabolism and nutrition disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Nausea/vomiting | Metabolism and nutrition disorders | — |
| Diarrhea | Metabolism and nutrition disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Febrile Neutropenia | Blood and lymphatic system disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Infection | Metabolism and nutrition disorders | — |
| Hypotension | Metabolism and nutrition disorders | — |
| Weight loss | Metabolism and nutrition disorders | — |
| Dysphagia | Metabolism and nutrition disorders | — |
| Mucositis, Oral | Metabolism and nutrition disorders | — |
| Gastrointestinal, Other | Metabolism and nutrition disorders | — |
| Fatigue | Metabolism and nutrition disorders | — |
| ALT/ALK phosphatase elevated | Metabolism and nutrition disorders | — |
| Cardiac | Metabolism and nutrition disorders | — |
| Acute kidney injury | Metabolism and nutrition disorders | — |
| Aspiration | Metabolism and nutrition disorders | — |
Most-reported serious reactions: Lymphopenia/Leukopenia/Neutropenia, Hypokalemia/Hyponatremia/Hypocalcemia, Thrombocytopenia, Nausea/vomiting, Diarrhea, Anemia, Dehydration, Febrile Neutropenia.
Data from ClinicalTrials.gov NCT03279237 adverse events section.
This research study is studying a combination of interventions as a possible treatment for gastroesophageal (GE) junction cancer. The interventions involved in this study are: -FOLFIRINOX which is made up of 4 different drugs: * 5-Fluorouracil (5-FU) * Oxaliplatin * Irinotecan * Leucovorin * Paclitaxel * Carboplatin * Proton Beam Radiation Therapy
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03279237.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing