New combo therapy aims to shrink tough rectal tumors before surgery
NCT ID NCT01941641
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests a two-step approach for high-risk rectal cancer: first, a strong chemotherapy cocktail (FOLFOXIRI), followed by radiation combined with a chemo pill (capecitabine). The goal is to shrink tumors before surgery, making them easier to remove. The study involves 40 adults with aggressive rectal cancer and will measure how well the tumor responds and how safe the treatment is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FOLFOXIRI (combination chemotherapy) and capecitabine (chemotherapy pill)
- What this could lead to
- If successful, this approach could shrink high-risk rectal tumors before surgery, making them easier to remove and potentially reducing the chance of cancer coming back.
- What could go wrong
- This is a small, early-phase trial with only 40 participants, so results may not apply to everyone. Chemotherapy and radiotherapy have significant side effects, and the treatment may not work for all patients.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2013
- Expected to finish
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Dec 2027
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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18 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: * 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 operable where there is a significant risk of positive surgical margin: * T3 (low-lying tumour at or below the levators) or T4, or * Tumour infiltrating perirectal fat, or * Any T-stage (T1-4) and node-positive tumour (invading surrounding structures or peritoneum) * 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, calculated creatinine clearance \>= 55 ml/min, total bilirubin =\<1.5 x the upper limit of normal, alanine aminotransferase (ALT) =\<2.5 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 non-invasive DCIS of the breast. * Upper rectal cancer that is located above the peritoneal reflection. * 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 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.
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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
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Department of Clinical Oncology
Hong Kong, Hong Kong
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Other studies related to the condition(s) this trial covers.
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