Can adding chemo after radiation help older adults with rectal cancer avoid surgery?
NCT ID NCT07118800
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This phase 3 trial is testing whether adding a three-month course of FOLFOX4s chemotherapy after short-course radiotherapy improves outcomes compared to radiotherapy alone in adults aged 75 and older with locally advanced rectal cancer. The study aims to see if the combination can shrink tumors enough to avoid major surgery. Participants are randomly assigned to receive either short-course radiation alone or radiation followed by chemotherapy, with close monitoring for tumor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FOLFOX4s chemotherapy (oxaliplatin, folinic acid, fluorouracil) after short-course radiotherapy
- What this could lead to
- If successful, this approach could offer a more effective, less invasive treatment option for elderly patients with rectal cancer, potentially avoiding surgery.
- What could go wrong
- Adding chemotherapy after radiation may increase side effects in older adults. The trial is still testing whether the combination is truly better than radiation alone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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75 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically confirmed diagnosis of adenocarcinoma of the rectum 2. Age ≥75 years 3. WHO performance status 0-1 4. cT3a-b with maximum diameter \> 5 cm, T3c-d or cT4 tumor on pretreatment pelvic MRI 5. General condition considered suitable for radical pelvic surgery and a systemic therapy with FOLFOX, 6. Distal part of the tumor ≤10 cm from the anal margin, the measurement done by pelvic MRI 7. Oncogeriatrician approval 8. Adequate biological function defined by: 1. Neutrophils ≥ 1500/mm3 2. Platelets ≥ 100 000/mm3 3. Hemoglobin ≥ 10g/dL 4. Total bilirubin ≤ 1,5 x ULN 5. Alkaline phosphatases ≤ 1,5 x ULN 6. Creatinine clearance \>50mL/mn (MDRD) 9. Men must agree to use adequate contraception methods for the duration of study treatment and for within 6 months after completing treatment 10. Patients must be affiliated to a Social Security System (or equivalent). 11. 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 12. 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. Exclusion Criteria: 1. Metastatic disease 2. Other cancer within 3 years prior to rectal cancer diagnosis (except for in situ cancer and basal cell carcinoma of the skin) 3. Non resectable cancer, including extension to prostate or extension to perineal muscles 4. History of pelvic irradiation 5. Contraindication to FOLFOX 4s chemotherapy and/or radiotherapy and/or TME surgery 6. Contraindication to MRI 7. Microsatellite instability (MSI) and/or mismatch repair deficiency (dMMR) 8. Complete or partial Dihydropyrimidine Deshydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL) 9. 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 10. 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). 11. Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomization 12. Any psychiatric disorder precluding understanding of information of trial related topics and giving informed consent 13. No prior chemotherapy or surgery for rectal cancer 14. Any serious underlying medical condition (as judged by the investigator) that could impair the ability of the patient to participate in the trial 15. Persons deprived of their liberty or under protective custody or guardianship. 16. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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