Trial Outcomes & Findings for A Pilot Study of FOLFIRINOX in Combination With Neoadjuvant Radiation for Gastric and GE Junction Cancers (NCT NCT03279237)

NCT ID: NCT03279237

Last Updated: 2025-11-25

Results Overview

The number of participants that complete the assigned study intervention.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 25 participants
• Primary outcome timeframe: 21 weeks
• Results posted on: 2025-11-25

Participant Flow

Participant milestones

Measure	FOLFIRINOX + pre-operative radiation * 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 Irinotecan: May help shrink tumor before surgery. Oxaliplatin: May help shrink tumor before surgery. Leucovorin: May help shrink tumor before surgery. 5-Fluorouracil: May help shrink tumor before surgery. Paclitaxel: Paclitaxel may stop cancer cells from growing and spreading. Radiation Therapy: May help shrink tumor. Carboplatin: Carboplatin may stop cancer cells from growing.
Overall Study STARTED	25
Overall Study Chemo-radiation	23
Overall Study Surgical Resection	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	FOLFIRINOX + Pre-operative Radiation n=25 Participants * 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 Irinotecan: May help shrink tumor before surgery. Oxaliplatin: May help shrink tumor before surgery. Leucovorin: May help shrink tumor before surgery. 5-Fluorouracil: May help shrink tumor before surgery. Paclitaxel: Paclitaxel may stop cancer cells from growing and spreading. Radiation Therapy: May help shrink tumor. Carboplatin: Carboplatin may stop cancer cells from growing.
Age, Continuous	60 years n=25 Participants
Sex: Female, Male Female	8 Participants n=25 Participants
Sex: Female, Male Male	17 Participants n=25 Participants
Region of Enrollment United States	25 participants n=25 Participants

PRIMARY outcome

Timeframe: 21 weeks

The number of participants that complete the assigned study intervention.

Outcome measures

Measure

FOLFIRINOX + pre-operative radiation n=25 Participants * 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 Irinotecan: May help shrink tumor before surgery. Oxaliplatin: May help shrink tumor before surgery. Leucovorin: May help shrink tumor before surgery. 5-Fluorouracil: May help shrink tumor before surgery. Paclitaxel: Paclitaxel may stop cancer cells from growing and spreading. Radiation Therapy: May help shrink tumor. Carboplatin: Carboplatin may stop cancer cells from growing.

The Completion Rate of Chemotherapy in Combination With Chemoradiation

23 Participants

SECONDARY outcome

Timeframe: From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks)

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).

Outcome measures

Measure

FOLFIRINOX + pre-operative radiation n=25 Participants * 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 Irinotecan: May help shrink tumor before surgery. Oxaliplatin: May help shrink tumor before surgery. Leucovorin: May help shrink tumor before surgery. 5-Fluorouracil: May help shrink tumor before surgery. Paclitaxel: Paclitaxel may stop cancer cells from growing and spreading. Radiation Therapy: May help shrink tumor. Carboplatin: Carboplatin may stop cancer cells from growing.

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

25 Participants

SECONDARY outcome

Timeframe: After 4 and 8 cycles of FOLFIRINOX (8 and 16 weeks); and 3-4 weeks after chemo radiation (24-25 weeks)

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.

Outcome measures

Measure

FOLFIRINOX + pre-operative radiation n=25 Participants * 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 Irinotecan: May help shrink tumor before surgery. Oxaliplatin: May help shrink tumor before surgery. Leucovorin: May help shrink tumor before surgery. 5-Fluorouracil: May help shrink tumor before surgery. Paclitaxel: Paclitaxel may stop cancer cells from growing and spreading. Radiation Therapy: May help shrink tumor. Carboplatin: Carboplatin may stop cancer cells from growing.

Clinical Response Rate

20 Participants

SECONDARY outcome

Timeframe: 29 Weeks

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.

Outcome measures

Measure

FOLFIRINOX + pre-operative radiation n=25 Participants * 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 Irinotecan: May help shrink tumor before surgery. Oxaliplatin: May help shrink tumor before surgery. Leucovorin: May help shrink tumor before surgery. 5-Fluorouracil: May help shrink tumor before surgery. Paclitaxel: Paclitaxel may stop cancer cells from growing and spreading. Radiation Therapy: May help shrink tumor. Carboplatin: Carboplatin may stop cancer cells from growing.

Pathologic Complete Response Rate

7 Participants

SECONDARY outcome

Timeframe: 5 Years

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 Years

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.

Outcome measures

Outcome data not reported

Adverse Events

FOLFIRINOX + pre-operative radiation

Serious events: 24 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	FOLFIRINOX + pre-operative radiation n=25 participants at risk * 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 Irinotecan: May help shrink tumor before surgery. Oxaliplatin: May help shrink tumor before surgery. Leucovorin: May help shrink tumor before surgery. 5-Fluorouracil: May help shrink tumor before surgery. Paclitaxel: Paclitaxel may stop cancer cells from growing and spreading. Radiation Therapy: May help shrink tumor. Carboplatin: Carboplatin may stop cancer cells from growing.
Blood and lymphatic system disorders Lymphopenia/Leukopenia/Neutropenia	84.0% 21/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Blood and lymphatic system disorders Febrile Neutropenia	8.0% 2/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Blood and lymphatic system disorders Thrombocytopenia	16.0% 4/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Blood and lymphatic system disorders Anemia	12.0% 3/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders Hypokalemia/Hyponatremia/Hypocalcemia	20.0% 5/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders Dehydration	12.0% 3/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders Anorexia	8.0% 2/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders Weight loss	4.0% 1/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders Nausea/vomiting	16.0% 4/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders Diarrhea	16.0% 4/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders Dysphagia	4.0% 1/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders Mucositis, Oral	4.0% 1/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders Gastrointestinal, Other	4.0% 1/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders Infection	8.0% 2/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders Hypotension	8.0% 2/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders Fatigue	4.0% 1/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders ALT/ALK phosphatase elevated	4.0% 1/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders Cardiac	4.0% 1/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders Acute kidney injury	4.0% 1/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.
Metabolism and nutrition disorders Aspiration	4.0% 1/25 • From the start of treatment until 30 days after the end of treatment (up to approximately 25 weeks) Serious adverse events were defined as grade 3 or greater adverse events that were deemed to be at least possibly, probably, or definitely related to treatment. Non-serious adverse events were not captured.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Theodore Hong

Massachusetts General Hospital

Phone: (617) 726-2000

Email: TSHONG1@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place