Colon CancerPhase 3FOxTROT2FranceNCT06293625
Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced but Resecable Colon Cancer in the Elderly of 70 Years Old or More
A Phase 3 study testing Folfox and Surgery in people with Colon Cancer, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Colon cancer (CC) is the 5th most common cancer worldwide. Standard care for locally advanced disease is surgical resection followed by 3-6 months of adjuvant chemotherapy (AC) with oxaliplatin and 5-fluorouracil (OxFp). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Folfox and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2024to Jun 2032
- Phase
- Phase 3
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Biopsy-confirmed adenocarcinoma of the colon (or upper rectum if too high for radiotherapy), high-grade dysplasia is not acceptable ,
- Patients with synchronous tumors are eligible, if the most advanced tumor meets the criteria above
- Radiological stage T3/T4 and N0/N1/N2 and M0
- Patient eligible for curative surgery (without the need for of chemotherapy)
- No clinical, radiological and colonoscopy evidence of bowel obstruction
- Age ≥ 70 at the time of registration
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- pMMR/MSS tumour status
- Fit to receive 6 weeks (3 courses) of NAC with FOLFOX (either full or 80% of FOLFOX dose) and surgery, as assessed by a colon cancer specialist or geriatric oncologist (if available on site).
- Uracilemia <16 ng/ml.
- Adequate full blood count: WBC >3.0 x109/l; platelets >100 x109/l and neutrophils ≥ 1.5 x x109/l Anaemia (Hb < 10.0 g/dl) is not an exclusion, but should be corrected by transfusion prior to surgery and chemotherapy. If Hb remains low despite transfusions, surgery and chemotherapy can be given according to the decision of the surgical and oncology teams.
- Serum electrolytes: Ca2+ > 2.1 mmol/L, Mg2+ > 0.65 mmol/L, K+> 3.4 mmol/LAdequate renal biochemistry: GFR >50 ml/min as assessed by local standards
- Adequate hepatobiliary function:
- bilirubin < 1.5 x ULN (Patients with Gilbert's syndrome who have raised bilirubin but otherwise normal liver function tests are eligible for the study if bilirubin < 3 x ULN)
- AST/ALT < 2.5 x ULN
- Patient able to understand and willing to provide written informed consent for the study
- Patient affiliated to a social security scheme
Who cannot join
- Any patient for whom radiotherapy is advised by the MDT
- Strong evidence of distant metastases or peritoneal nodules (cM1), However, cases with indeterminate abnormalities should be managed and investigated as per standard local MDT procedures and can be considered for trial entry if the MDT opinion is that these are considered most likely to be benign.
- Peritonitis (secondary to perforated tumour)
- T1-T2
- Serious medical comorbidity, as assessed by leading clinician (such as uncontrolled angina)
- Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk <10%
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- Known dMMR/ MSI-H tumour status
- Have a peripheral sensitive neuropathy with functional impairment (≥ grade 2 according to NCI-CTCAE v5.0)
- Recent (within four weeks prior to randomisation) or concomitant treatment with brivudine, sorivudine or their chemically related analogues
- Person under guardianship, curatorship, and safeguard of justice or person deprived of liberty
- Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons
- Known hypersensitivity to the active substance of the trial treatments or to any of the excipients
- Patient with poor nutritional status at appreciation by each clinician
- bone marrow hypoplasia
- Potentially severe infection within1 month before NAC
- Patients who have received live attenuated vaccines (yellow fever, varicella, shingles, measles, mumps, rubella, tuberculosis, rotavirus, influenza) within 1 month before NAC
- Any case of clinically significant active heart disease or myocardial infarction within 6 months,
- Any chronic condition not controlled in the last 6 months: Liver failure, renal failure, respiratory failure,
- QT/QTc interval > 450 msec for men and > 470 msec for women
- Known Pernicious anaemia or other anaemias due to vitamin B12 deficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Côme LEPAGE contact
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21000
Côme LEPAGE, come.lepage@u-bourgogne.fr
About this study
Official title: Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced but Resecable Colon Cancer in the Elderly of 70 Years Old or More Phase III Multicentric Open-label Randomized Controlled Trial
Colon cancer (CC) is the 5th most common cancer worldwide. Standard care for locally advanced disease is surgical resection followed by 3-6 months of adjuvant chemotherapy (AC) with oxaliplatin and 5-fluorouracil (OxFp).
Almost all of these patients undergo surgery, but many do not receive AC due to frailty (following surgery). This particularly affects patients over 70, who represent the majority of patients diagnosed with CC.
FOxTROT 2, a trial to test the role of NAC in older patients.
- Conditions
- Colon Cancer
- Being tested
- Folfox, Surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FolfoxDrug
Folfox chemotherapy (folinic acid, fluorouracil and oxaliplatin) for 6 weeks (3 courses) before surgery.
SurgeryProcedure or surgery
Experimental arm: Surgery should take place 21 days after the last dose of neoadjuvant chemotherapy Control arm: upfront surgery as soon as possible
| Study group | Role | What they receive |
|---|---|---|
| NeoAdjuvant Chemotherapy arm | Experimental | Not described Receives: Drug: Folfox; Procedure: Surgery |
| Current standard of care | Active comparator | Not described Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS (disease Free Survival)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start7 Jun 2024
- Primary completionJun 2032 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293625
- Sponsor's protocol ID
- LEPAGE PHRCK 2022-2
- Acronym
- FOxTROT2France
- Status last verified
- Mar 2025
- First submitted
- 19 Feb 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced but Resecable Colon Cancer in the Elderly of 70 Years Old or More Phase III Multicentric Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06293625
- Acronym / sponsor ID
- FOxTROT2France / LEPAGE PHRCK 2022-2
- Conditions
- Colon Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- Jun 2032 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 5 Mar 2024 (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.
Colon cancer (CC) is the 5th most common cancer worldwide. Standard care for locally advanced disease is surgical resection followed by 3-6 months of adjuvant chemotherapy (AC) with oxaliplatin and 5-fluorouracil (OxFp).
Almost all of these patients undergo surgery, but many do not receive AC due to frailty (following surgery). This particularly affects patients over 70, who represent the majority of patients diagnosed with CC.
FOxTROT 2, a trial to test the role of NAC in older patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeoAdjuvant Chemotherapy arm | Experimental | Drug: Folfox, Procedure: Surgery |
| Current standard of care | Active comparator | Procedure: Surgery |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
- Biopsy-confirmed adenocarcinoma of the colon (or upper rectum if too high for radiotherapy), high-grade dysplasia is not acceptable ,
- Patients with synchronous tumors are eligible, if the most advanced tumor meets the criteria above
- Radiological stage T3/T4 and N0/N1/N2 and M0
- Patient eligible for curative surgery (without the need for of chemotherapy)
- No clinical, radiological and colonoscopy evidence of bowel obstruction
Key exclusion criteria (20 listed)
- Any patient for whom radiotherapy is advised by the MDT
- Strong evidence of distant metastases or peritoneal nodules (cM1), However, cases with indeterminate abnormalities should be managed and investigated as per standard local MDT procedures and can be considered for trial entry if the MDT opinion is that these are considered most likely to be benign.
- Peritonitis (secondary to perforated tumour)
- T1-T2
- Serious medical comorbidity, as assessed by leading clinician (such as uncontrolled angina)
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 |
|---|---|---|
| FolfoxFolfox chemotherapy (folinic acid, fluorouracil and oxaliplatin) for 6 weeks (3 courses) before surgery. | Drug | NeoAdjuvant Chemotherapy arm |
| SurgeryExperimental arm: Surgery should take place 21 days after the last dose of neoadjuvant chemotherapy Control arm: upfront surgery as soon as possible | Procedure or surgery | Current standard of care, NeoAdjuvant Chemotherapy arm |
Primary outcome
DFS (disease Free Survival)
Time frame: 3 years
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 30 Mar 2025.
- 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.
Côme LEPAGE contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Folfox and Surgery in people with Colon Cancer, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 16 inclusion and 20 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 30 Mar 2025. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Côme LEPAGE (come.lepage@u-bourgogne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (disease Free Survival) (time frame: 3 years). 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 30 Mar 2025.