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PRODIGE 87 FOXTROT II : Personalising and refining neo-adjuvant chemotherapy in locally advanced but resectable colon cancer in the elderly of 70 years old or more
EU CTIS ID: 2023-505214-23-00
What this study is testing
The primary objective is to demonstrate that the proportion of patients alive and disease-free at 3 years after randomization treated with 6 weeks (3 courses) of NeoAdjuvant Chemotherapy (FOLFOX) followed by surgery is superior compared to those going Straight To Surgery.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Biopsy-confirmed adenocarcinoma of the colon, high-grade dysplasia is acceptable with unequivocal radiological evidence of invasive cancer
- Adequate renal biochemistry
- Adequate hepatobiliary function
- Patient able to understand and willing to provide written informed consent for the study
- Patient affiliated to a social security scheme
- Radiological stage T3/T4 and N0/N1/N2 and M0
You likely can't join if
- Any patient for whom radiotherapy is advised by the multidisciplinary team metting
- Person under guardianship, curatorship, and safeguard of justice or person deprived of liberty
- Impossible to undergo the medical follow-up of the trial for geographical, social or psychological reasons
- 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
See the full eligibility criteria
- Biopsy-confirmed adenocarcinoma of the colon, high-grade dysplasia is acceptable with unequivocal radiological evidence of invasive cancer
- Adequate renal biochemistry
- Adequate hepatobiliary function
- Patient able to understand and willing to provide written informed consent for the study
- Patient affiliated to a social security scheme
- Radiological stage T3/T4 and N0/N1/N2 and M0
- Patient eligible for curative surgery
- No clinical or radiological evidence of bowel obstruction
- Age ≥ 70 at the time of registration
- pMMR/MSS tumour status
- Colon cancer specialist assessed fit to receive 6 weeks (3 courses) of NAC with FOLFOX and surgery
- Homozygous for DPYD germline mutation
- Homozygous for DPYD germline mutation
- Any patient for whom radiotherapy is advised by the multidisciplinary team metting
- Person under guardianship, curatorship, and safeguard of justice or person deprived of liberty
- Impossible to undergo the medical follow-up of the trial for geographical, social or psychological reasons
- 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 1 month before NAC
- Patients who have received live attenuated vaccines (yellow fever, varicella, shingles, measles, mumps, rubella, tuberculosis, rotavirus, influenza) 1 month before NAC
- Any chronic condition not balanced in the last 6 months: liver failure, renal failure, respiratory failure, heart failu
- QT/QTc interval > 450 msec for men and > 470 msec for women
- Known Pernicious anaemia or other anaemias due to vitamin B12 deficiency
- Strong evidence of distant metastases or peritoneal nodules
- Peritonitis
- T1-T2
- Serious medical comorbidity, as assessed by leading clinician
- 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
- Recent (within four weeks prior to randomisation) or concomitant treatment with brivudine, sorivudine or their chemically related analogues
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.