Colorectal CancerNCT05780684
Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer
A study testing FOX dose-escalation algorithm in people with Colorectal Cancer and Esophagus Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This is a single-arm clinical trial to evaluate the feasibility of a chemotherapy regimen using adaptive, individualized dose escalation of 5-FU chemotherapy for patients who have good tolerance of the initial dose. Study participants will also receive oxaliplatin chemotherapy together with 5-FU, at standard doses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Esophagus Cancer, Appendix Cancer
- What is being tested?
- FOX dose-escalation algorithm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosis of metastatic or locally advanced/inoperable colorectal cancer or non-colorectal gastrointestinal cancer (including cancers of the stomach, esophagus, appendix, small bowel, and ampulla)
- Clinically appropriate staging imaging of the chest, abdomen, and pelvis performed within 30 days prior to registration
- ECOG Performance Status: 0-1
Who cannot join
- Any prior receipt of oxaliplatin or fluoropyrimidine chemotherapy (other than radiation-sensitizing fluoropyrimidine chemotherapy)
- Prior receipt of systemic chemotherapy in the 6 months prior to Day 1 of Cycle 1 of FOX (other than radiation-sensitizing chemotherapy)
- Known mismatch repair deficiency or microsatellite instability-high disease
- Known dihydropyrimidine dehydrogenase (DPD) deficiency, as identified by clinically indicated screening
- Any confirmed second malignancy that is likely to require systemic therapy during the course of the six-month study period, in the opinion of the enrolling investigator
- Any of the following baseline laboratory abnormalities:
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- Absolute neutrophil count (ANC) < 2,500/mm3
- Platelet count < 100,000/mm3
- Hemoglobin < 9 g/dL
- Creatinine > 1.5 x ULN
- Total bilirubin > 1.5 x ULN
- AST/ALT > 5 x ULN
- Patients who are unable to provide informed consent
- Patients who are pregnant or breastfeeding
- Patients who are incarcerated, homeless, or have active substance use disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Gabriel A Brooks, MD, 603-650-9474, gabriel.a.brooks@hitchcock.org
Gabriel A Brooks, MD
About this study
Official title: Adaptive, Individualized Dose Escalation of Fluorouracil-Based Chemotherapy for Gastrointestinal Cancer: Pilot Study of the FOX Regimen
This is a single-arm clinical trial to evaluate the feasibility of a chemotherapy regimen using adaptive, individualized dose escalation of 5-FU chemotherapy for patients who have good tolerance of the initial dose. Study participants will also receive oxaliplatin chemotherapy together with 5-FU, at standard doses. The goal of the study is to examine the feasibility and effectiveness of this approach, using individualized dose escalation of 5-FU in patients who do not have serious side effects at lower doses.
- Conditions
- Colorectal Cancer, Esophagus Cancer, Appendix Cancer, Small Bowel Cancer, Ampullary Cancer
- Being tested
- FOX dose-escalation algorithm
- Medical subject headings
- Colorectal Neoplasms, Esophageal Neoplasms, Appendiceal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOX dose-escalation algorithmOther
Chemotherapy dose-escalation algorithm based on the FOLFOX and FOLFOXIRI regimens
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | All patients in this single-study arm will be exposed to the FOX regimen, an adaptively dose-escalated chemotherapy regimen. The FOX regimen is comprised of oxaliplatin 85 mg/m2 IV on Day 1; leucovorin calcium 350 mg IV on Day 1; and infusional 5-FU IV over 46 hours (Days 1 and 2) - starting at a dose of 2,400 mg/m2 and adaptively adjusted toward a maximum dose of 3,200 mg/m2 over Cycles 2-4 using a clinical algorithm. Receives: Other: FOX dose-escalation algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that receive dose intensified infusional 5-FU in Cycle 6 of the FOX regimen
The proportion of patients who receive dose-intensified infusional 5-FU (dosed at greater than or equal to 2,800 mg/m2) in Cycle 6 of the FOX regimen.
Measured: Through day 1 of Cycle 6 of FOX regimen (cycle length is 14 days)
Secondary outcomes (5)
Response rate to chemotherapy
Response rate (stratified by colorectal cancer vs. gastroesophageal cancer) as defined using RECIST 1.1 imaging criteria
Measured: Through 6 months from Cycle 1 Day 1 of FOX regimen
Progression-free survival
Progression-free survival (PFS, stratified by colorectal cancer vs. gastroesophageal cancer, determined by retrospective review of medical records)
Measured: Through 12 months from Cycle 1 Day 1 of FOX regimen
Dose intensity of 5-FU and oxaliplatin
Dose intensity of 5-FU and oxaliplatin over Cycles 1-6. Dose intensity will be calculated separately for each component of the FOLFOX regimen (5-FU infusion and oxaliplatin).
Measured: Through day 1 of Cycle 6 of FOX regimen (cycle length is 14 days)
Mean plasma uracil concentration
Difference in mean plasma uracil concentration between patients who did and did not achieve sustained 5-FU dose escalation to ≥ 2,800 mg/m2 (primary endpoint)
Measured: Single treatment visit 0-30 days before Day 1 of Cycle 1 of FOX regimen, (cycle length is 14 days)
5-FU drug exposure
5-FU drug exposure, measured as the area under the drug concentration curve (AUC). AUC will be calculated by multiplying the measured 5-FU concentration at steady state by the 5-FU infusion duration in hours.
Measured: Single treatment visit on Day 3 of treament Cycle 5 or Cycle 6 of FOX regimen, (cycle length is 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start14 Jul 2023
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel A. Brooks, Dartmouth-Hitchcock Medical Center
- Investigators
- Gabriel A Brooks, M.D., Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780684
- Sponsor's protocol ID
- STUDY02001873
- Other IDs
- 22BRO873
- Status last verified
- May 2026
- First submitted
- 10 Mar 2023
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive, Individualized Dose Escalation of Fluorouracil-Based Chemotherapy for Gastrointestinal Cancer: Pilot Study of the FOX Regimen
- ClinicalTrials.gov ID
- NCT05780684
- Acronym / sponsor ID
- STUDY02001873
- Conditions
- Colorectal Cancer, Esophagus Cancer, Appendix Cancer, Small Bowel Cancer, Ampullary Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm clinical trial to evaluate the feasibility of a chemotherapy regimen using adaptive, individualized dose escalation of 5-FU chemotherapy for patients who have good tolerance of the initial dose. Study participants will also receive oxaliplatin chemotherapy together with 5-FU, at standard doses. The goal of the study is to examine the feasibility and effectiveness of this approach, using individualized dose escalation of 5-FU in patients who do not have serious side effects at lower doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Other: FOX dose-escalation algorithmAll patients in this single-study arm will be exposed to the FOX regimen, an adaptively dose-escalated chemotherapy regimen. The FOX regimen is comprised of oxaliplatin 85 mg/m2 IV on Day 1; leucovorin calcium 350 mg IV on Day 1; and infusional 5-FU IV over 46 hours (Days 1 and 2) - starting at a dose of 2,400 mg/m2 and adaptively adjusted toward a maximum dose of 3,200 mg/m2 over Cycles 2-4 using a clinical algorithm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Diagnosis of metastatic or locally advanced/inoperable colorectal cancer or non-colorectal gastrointestinal cancer (including cancers of the stomach, esophagus, appendix, small bowel, and ampulla)
- Clinically appropriate staging imaging of the chest, abdomen, and pelvis performed within 30 days prior to registration
- ECOG Performance Status: 0-1
Key exclusion criteria (15 listed)
- Any prior receipt of oxaliplatin or fluoropyrimidine chemotherapy (other than radiation-sensitizing fluoropyrimidine chemotherapy)
- Prior receipt of systemic chemotherapy in the 6 months prior to Day 1 of Cycle 1 of FOX (other than radiation-sensitizing chemotherapy)
- Known mismatch repair deficiency or microsatellite instability-high disease
- Known dihydropyrimidine dehydrogenase (DPD) deficiency, as identified by clinically indicated screening
- Any confirmed second malignancy that is likely to require systemic therapy during the course of the six-month study period, in the opinion of the enrolling investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOX dose-escalation algorithmChemotherapy dose-escalation algorithm based on the FOLFOX and FOLFOXIRI regimens | Other | Study Arm |
Primary outcome
Proportion of patients that receive dose intensified infusional 5-FU in Cycle 6 of the FOX regimen
Time frame: Through day 1 of Cycle 6 of FOX regimen (cycle length is 14 days)
The proportion of patients who receive dose-intensified infusional 5-FU (dosed at greater than or equal to 2,800 mg/m2) in Cycle 6 of the FOX regimen.
5 secondary outcomes
Response rate to chemotherapy
Time frame: Through 6 months from Cycle 1 Day 1 of FOX regimen
Progression-free survival
Time frame: Through 12 months from Cycle 1 Day 1 of FOX regimen
Dose intensity of 5-FU and oxaliplatin
Time frame: Through day 1 of Cycle 6 of FOX regimen (cycle length is 14 days)
Mean plasma uracil concentration
Time frame: Single treatment visit 0-30 days before Day 1 of Cycle 1 of FOX regimen, (cycle length is 14 days)
5-FU drug exposure
Time frame: Single treatment visit on Day 3 of treament Cycle 5 or Cycle 6 of FOX regimen, (cycle length is 14 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriel A Brooks, M.D. principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOX dose-escalation algorithm in people with Colorectal Cancer and Esophagus Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Nurse (603-653-3637, cancer.research.nurse@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients that receive dose intensified infusional 5-FU in Cycle 6 of the FOX regimen (time frame: Through day 1 of Cycle 6 of FOX regimen (cycle length is 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.