Can adding chemo after radiation help older adults with rectal cancer avoid surgery?

NCT ID NCT07118800

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jan 2032

An estimate. End dates often move.

Lead sponsor

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

75 years and older

Sex

Anyone

Healthy volunteers

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

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

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How to take part

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