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Aggressive chemo cocktail aims to wipe out rectal cancer before surgery

NCT ID NCT03997435

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether adding a stronger chemotherapy regimen (FOLFOXIRI) before the usual chemoradiation and surgery can improve outcomes for people with high-risk locally advanced rectal cancer. About 72 participants will be randomly assigned to either standard treatment or the intensified approach. The main goal is to see if more tumors completely disappear (pathologic complete response) with the extra chemo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FOLFOXIRI chemotherapy regimen
What this could lead to
If successful, this could lead to a more effective treatment approach for high-risk rectal cancer, potentially increasing the chance of a complete response before surgery.
What could go wrong
This is a small, early-phase trial with only 72 participants, so results may not apply broadly. Adding more chemotherapy also raises the risk of side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

72 people

The number who actually took part.

Started

Sep 2019

Expected to finish

Dec 2027

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

18 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: * Able to provide written informed consent * Age \>= 18 years of either sex. * ECOG performance status 0-1 * Measurable disease by RECIST 1.1 criteria. * Histologically confirmed rectal adenocarcinoma (defined as either mid- or low rectal cancer that is located within 12 cm from the anal verge OR below the peritoneal reflection) that is previously untreated. * 'High risk' rectal cancer, or rectal cancers that are considered marginally perable where there is a significant risk of positive surgical margin: * T3 or T4, and / or * Tumour infiltrating perirectal fat and/ or mesorectal fascia, and / or Involvement of pelvic lymph nodes, and/or * Tumour invading surrounding structures or peritoneum or vasculature. * Adequate bone marrow, renal and hepatic function as defined by: absolute neutrophil count \>= 1.5 x 109/L, hemoglobin \>= 9 g/L, platelets \>= 100 x 109/L, serum creatinine level \< 1.5 x ULN (or calculated creatinine clearance \>=50 ml/min, whichever is worse), total bilirubin \<=1.5 x the upper limit of normal, alanine aminotransferase (ALT) \< 3 upper limit of normal. Exclusion Criteria: * Known distant metastasis, even if the metastasis has been resected. * History of another invasive malignancy within the last 5 years, except for treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia, or breast DCIS. * Upper rectal cancer that is located above the peritoneal reflection. * Patients with synchronous colon and rectal cancers are not excluded as long as: (1) these tumors are considered as two separate primaries (i.e. not metastasis or a contiguous part of a large primary), (2) both tumors are not causing imminent obstruction; (3) pelvic radiotherapy is not considered a contraindication. * Primary tumour associated with any one of the following features:Frank intestinal obstruction, or * Endoscope unable to pass through the tumour's lumen plus worsening local obstructive symptoms. Note: Patients with such features should be assessed by the surgical team regarding stomal bypass prior to study enrolment. Such patients can still be considered for study enrolment after undergoing stomal bypass. * Known hypersensitivity reaction to the study drugs (i.e. fluoropyrimidine, irinotecan, oxaliplatin) * Known peripheral neuropathy of grade 2 or more in severity.\\ -Patients who have received an experimental anticancer therapy within the last 28 days. * Previous pelvic radiotherapy * Previous oxaliplatin or irinotecan for the treatment of colon or rectal cancer. * Patient with hip prosthesis * Major surgery (i.e. requiring general anaesthetics) within the last 28 days. Exception: Any patient who underwent stomal bypass for obstructing primary tumour within the last 14 days are still eligible, as long as the patient has sufficiently recovered from the surgery at the investigator's discretion. * Known cardiac disease that is symptomatic or poorly controlled, including cardiac failure, arrhythmia or ischemic heart disease. * Myocardial infarction or cerebrovascular accident within the last 12 months. * Intercurrent infections or medical illnesses that are serious/ potentially life-threatening and require ongoing treatment. * Patients who are unable to take capecitabine tablets uncrushed by the oral route (e.g. enteral feeding). Patients with significantly impaired gastrointestinal integrity and absorption are excluded. * Patients with known and untreated bilateral hydronephrosis and/or hydroureters (or unilateral hydronephrosis and/or hydroureters in any patient with a single kidney) are excluded. The obstruction should be treated with ureteric stent(s) or percutaneous nephrostomy(s) prior to study enrolment. Patients with unilateral hydronephrosis and/or hydroureters and adequate renal function (i.e. as stated in the eligibility criteria: serum creatinine level \< 1.5 x ULN, or calculated creatinine clearance \>=50 ml/min - whichever is worse) are not excluded. * Patients on warfarin therapy. Patients on low molecular weight heparin are not excluded. * Pregnant or lactating women. * Patients with reproductive potential who are not willing to use barrier method of birth control. * Patients who are unable to provide written informed consent, or to comply with study requirements as judged by the investigator. * Patients who refuse surgical treatment of the rectal cancer.

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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.

Contacts and locations

Locations

  • Department of Clinical Oncology, Queen Mary Hospital

    Hong Kong, Hong Kong

  • Department of Oncology, Princess Margaret Hospital

    Hong Kong, Hong Kong

  • The Chinese University of Hong Kong

    Hong Kong, Hong Kong

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