A Phase 1 interventional study of Irinotecan and Oxaliplatin in GastroEsophageal Cancer, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Massachusetts General Hospital · Phase 1, Interventional, and Treatment
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:
This research study is a Pilot Study, which is the first time investigators are examining this study intervention.
In this research study, the investigators are studying the combination of FOLFIRINOX followed by radiation with paclitaxel and carboplatin before surgery. The investigators believe that this intervention may help decrease the growth and spread of the cancer cells.
FOLFIRINOX has shown to be very effective in patients whom disease has spread. The investigators are evaluating this regimen to see if there is an increase in curability when the cancer has not spread.
The FDA (the U.S. Food and Drug Administration) has approved FOLFIRINOX as a treatment option for this disease.
The FDA has not approved Paclitaxel or Carboplatin for this specific disease but they have both been approved for other uses.
FOLFIRINOX is a combination of 4 chemotherapy agents that may help shrink the tumor before surgery.
Carboplatin may stop the cancer cells from growing and paclitaxel may stop the cancer cells from growing and spreading
Participants must have adequate organ and marrow function as defined below:
Exclusion Criteria:
* FOLFIRINOX is a combination of 4 drugs that is administered twice per cycle * Oxaliplatin is administered intravenously * Leucovorin is administered intravenously * Irinotecan is administered intravenously * 5-Fluorouracil is administered intravenously * Paclitaxel and Carboplatin will be given concurrently with radiation therapy every 7 days
Drug: Irinotecan · Drug: Oxaliplatin · Drug: Leucovorin · Drug: 5-Fluorouracil · Drug: Paclitaxel · Radiation: Radiation Therapy · Drug: Carboplatin
May help shrink tumor before surgery.
Also known as: Camptosar
May help shrink tumor before surgery.
Also known as: Eloxatin
May help shrink tumor before surgery.
May help shrink tumor before surgery.
Also known as: Efudex
Paclitaxel may stop cancer cells from growing and spreading.
Also known as: Abraxane
May help shrink tumor.
Carboplatin may stop cancer cells from growing.
The Completion Rate of Chemotherapy in Combination With Chemoradiation
The number of participants that complete the assigned study intervention.
Time frame: 21 weeks
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
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).
Time frame: From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks)
Clinical Response Rate
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.
Time frame: After 4 and 8 cycles of FOLFIRINOX (8 and 16 weeks); and 3-4 weeks after chemo radiation (24-25 weeks)
Pathologic Complete Response Rate
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.
Time frame: 29 Weeks
Progression Free Survival
Progression-free survival (PFS) is defined as the time from the date of first dosing to the first documentation of radiographic disease progression per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) or death due to any cause, whichever occurs first. Subjects who are alive with no documented progressive disease by the data cutoff date for PFS analysis will be censored at the date of their last evaluable disease assessment. Progressive Disease (PD) is defined as having at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Time frame: 5 Years
Overall Survival
The number of participants alive five years after the start of treatment. Overall survival (OS) is measured as the time from the date of first dosing until death due to any cause. If there is no death reported for a subject by the data cut-off date for overall survival analysis, OS will be censored at the last known alive date.
Time frame: 5 Years
| Milestone | FOLFIRINOX + Pre-operative Radiation |
|---|---|
| Started | 25 |
| Chemo-radiation | 23 |
| Surgical resection | 20 |
| Completed | 20 |
| Not completed | 5 |
The number of participants that complete the assigned study intervention.
| Participants | FOLFIRINOX + Pre-operative Radiation |
|---|---|
| The Completion Rate of Chemotherapy in Combination With Chemoradiation | 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).
| Participants | FOLFIRINOX + Pre-operative Radiation |
|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 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.
| Participants | FOLFIRINOX + Pre-operative Radiation |
|---|---|
| Clinical Response Rate | 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.
| Participants | FOLFIRINOX + Pre-operative Radiation |
|---|---|
| Pathologic Complete Response Rate | 7 |
Progression-free survival (PFS) is defined as the time from the date of first dosing to the first documentation of radiographic disease progression per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) or death due to any cause, whichever occurs first. Subjects who are alive with no documented progressive disease by the data cutoff date for PFS analysis will be censored at the date of their last evaluable disease assessment. Progressive Disease (PD) is defined as having at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Results for this outcome have not been posted.
The number of participants alive five years after the start of treatment. Overall survival (OS) is measured as the time from the date of first dosing until death due to any cause. If there is no death reported for a subject by the data cut-off date for overall survival analysis, OS will be censored at the last known alive date.
Results for this outcome have not been posted.
Collected over From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FOLFIRINOX + Pre-operative Radiation | 1/25 (4%) | 24/25 (96%) | — |
| Event | FOLFIRINOX + Pre-operative Radiation |
|---|---|
| Lymphopenia/Leukopenia/NeutropeniaBlood and lymphatic system disorders | 21/25 |
| Hypokalemia/Hyponatremia/HypocalcemiaMetabolism and nutrition disorders | 5/25 |
| ThrombocytopeniaBlood and lymphatic system disorders | 4/25 |
| Nausea/vomitingMetabolism and nutrition disorders | 4/25 |
| DiarrheaMetabolism and nutrition disorders | 4/25 |
| AnemiaBlood and lymphatic system disorders | 3/25 |
| DehydrationMetabolism and nutrition disorders | 3/25 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 2/25 |
| AnorexiaMetabolism and nutrition disorders | 2/25 |
| InfectionMetabolism and nutrition disorders | 2/25 |
| Age, Continuous(years) | FOLFIRINOX + Pre-operative Radiation |
|---|---|
| Median | 60 (30 to 76) |
| Sex: Female, Male(Participants) | FOLFIRINOX + Pre-operative Radiation |
|---|---|
| Female | 8 |
| Male | 17 |
| Race and Ethnicity Not Collected(Participants) | FOLFIRINOX + Pre-operative Radiation |
|---|
| Region of Enrollment(participants) | FOLFIRINOX + Pre-operative Radiation |
|---|---|
| United States | 25 |
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Massachusetts General Hospital