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Study evaluating two treatment strategies for rectal cancer in patients ≥75 years old
EU CTIS ID: 2025-521619-37-00
What this study is testing
To compare efficacy of SCRT followed by 6 cycles of FOLFOX4s chemotherapy versus SCRT without chemotherapy in terms of organ preservation rate in elderly patients with locally advanced rectal cancer (cT3-T4).
- 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
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- Patients must be affiliated to a Social Security System (or equivalent).
- Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent
- Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures
- Age ≥75 years
- WHO performance status 0-1
You likely can't join if
- Metastatic disease
- Non resectable cancer, including extension to prostate or extension to perineal muscles
- History of pelvic irradiation
- Contraindication to FOLFOX 4s chemotherapy: Regarding the treatment with 5-fluorouracil: ➢ Recent (within the last 4 weeks) or concomitant treatment with brivudine ➢ Presence of a potentially serious infection Receipt of a live or live-attenuated vaccine within 30 days prior to the first dose of the study intervention ➢ Poor nutritional status/Clinically significant active heart disease or myocardial infarction within the past 6 months, given the cardiotoxicity of fluorouracil. Regarding the treatment with oxaliplatin: Due to the cardiotoxicity of oxaliplatin (risk of QT prolongation as described in section 4.4 of the oxaliplatin SmPC): ➢ hypokalemia less than normal ➢ hypomagnesemia ➢ hypocalcemia ➢ QT/QTc interval longer than 450 msec for men and longer than 470 msec for women on the inclusion ECG; Peripheral sensory neuropathy with functional impairment prior to the first treatment, according to the oxaliplatin SmPC. Known history of hypersensitivity to fluorouracil, oxaliplatin, folinic acid, or any of their excipients, as stated in the respective SmPCs.
- Contraindication to MRI
- Microsatellite instability (MSI) and/or mismatch repair deficiency (dMMR)
See the full eligibility criteria
Who can join
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- Patients must be affiliated to a Social Security System (or equivalent).
- Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent
- Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures
- Age ≥75 years
- WHO performance status 0-1
- cT3a-b with maximum diameter > 5 cm, T3c-d or cT4 tumor on pretreatment pelvic MRI
- General condition considered suitable for radical pelvic surgery and a systemic therapy with FOLFOX,
- Distal part of the tumor ≤10 cm from the anal margin, the measurement done by pelvic MRI
- Oncogeriatrician approval
- Adequate biological function defined by: a. Neutrophils ≥ 1500/mm3 b. Platelets ≥ 100 000/mm3 c. Hemoglobin ≥ 10g/dL d. Total bilirubin ≤ 1,5 x ULN e. Alkaline phosphatases ≤ 1,5 x ULN f. Creatinine clearance >50mL/mn (MDRD) g.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels 2.5× ULN
- Men must agree to use adequate contraception methods during treatment and at least until 12 months after the end of the treatment with oxaliplatin
What rules you out
- Metastatic disease
- Non resectable cancer, including extension to prostate or extension to perineal muscles
- History of pelvic irradiation
- Contraindication to FOLFOX 4s chemotherapy: Regarding the treatment with 5-fluorouracil: ➢ Recent (within the last 4 weeks) or concomitant treatment with brivudine ➢ Presence of a potentially serious infection Receipt of a live or live-attenuated vaccine within 30 days prior to the first dose of the study intervention ➢ Poor nutritional status/Clinically significant active heart disease or myocardial infarction within the past 6 months, given the cardiotoxicity of fluorouracil. Regarding the treatment with oxaliplatin: Due to the cardiotoxicity of oxaliplatin (risk of QT prolongation as described in section 4.4 of the oxaliplatin SmPC): ➢ hypokalemia less than normal ➢ hypomagnesemia ➢ hypocalcemia ➢ QT/QTc interval longer than 450 msec for men and longer than 470 msec for women on the inclusion ECG; Peripheral sensory neuropathy with functional impairment prior to the first treatment, according to the oxaliplatin SmPC. Known history of hypersensitivity to fluorouracil, oxaliplatin, folinic acid, or any of their excipients, as stated in the respective SmPCs.
- Contraindication to MRI
- Microsatellite instability (MSI) and/or mismatch repair deficiency (dMMR)
- Complete or partial Dihydropyrimidine Deshydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before start of treatment
- Contradiction radiotherapy and/or TME surgery
- Any other serious concomitant disease or disorder that may interfere with the patient's participation in the study and safety during the study (e.g., severe liver, heart, kidney, lung, metabolic, or psychiatric disorders).
- Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomization
- Any psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
- No prior chemotherapy or surgery for rectal cancer
- Any serious underlying medical condition (as judged by the investigator) that could impair the ability of the patient to participate in the trial
- Persons deprived of their liberty or under protective custody or guardianship.
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.
- Other cancer within 3 years prior to rectal cancer diagnosis (except for in situ cancer and basal cell carcinoma of the skin)
The study team makes the final eligibility decision.
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.
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.