Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Centre Hospitalier Universitaire Dijon (Voir sur ClinicalTrials)
juin 2024
juin 2032
11 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | NGUEFACK Rolande | 18/09/2025 17:50:11 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Dijon Bourgogne - 21000 - Dijon - France | Côme LEPAGE | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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
- 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
- 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%
- 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