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Surgery before chemo for advanced rectal cancer? small trial offers few answers
NCT ID NCT02314182
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether removing the primary rectal tumor before starting chemotherapy helps people with rectal cancer that has spread to other organs (but cannot be cured) live longer. Only 5 people took part, and the trial was completed early. The results are too limited to draw firm conclusions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Primary tumor resection followed by chemotherapy
- What this could lead to
- If successful, this could show that removing the main tumor before chemotherapy helps people with advanced rectal cancer live longer.
- What could go wrong
- This was a very small trial (only 5 participants) and was completed early, so results are not reliable. The approach may not improve survival and surgery carries risks like infection or complications.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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5 people
The number who actually took part.
- Started
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Nov 2014
- Finished
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Feb 2018
- 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 to 75 years
- 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: * Non-complicated primary tumor (i.e. tumor without obstruction, bleeding, abscess or perforation requiring emergency surgery and/or contra-indicating first-line chemotherapy) * Unresectable synchronous metastases * ECOG performance status 0-1 * Rectal adenocarcinoma (\<15 cm from the anal verge) with few or no symptoms and unresectable metastasis (assessed by the investigator) unsuitable for curative treatment * No known unresectable primary tumor (with clear margin \>1mm) on CT-scan and MRI * No disease progression under chemotherapy (for at least 4 cycles); * Assessment of KRAS status before randomization (wild type or mutated); * Life expectancy without cancer \>2 years * White blood cell count ≥ 3 x 109/L, with neutrophils ≥ 1,5 x 109/L, platelet count ≥ 100 x 109/L, hemoglobin°≥ 9 g/dL (5,6 mmol/l) * Total bilirubin ≤ 1.5 x ULN (upper limit of normal), ASAT and ALAT ≤ 2.5 x ULN, alkaline phosphatase°≤°1.5°x ULN, serum creatinine ≤ 1.5 x ULN; * Age ≥ 18 years ≤ 75 years * Patients with childbearing potential should use effective contraception during the study and up 6 months after the end of chemotherapy * Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research; * Signed written informed consent obtained prior to any study-specific screening procedures Exclusion Criteria: * Rectal tumor operated before inclusion * Symptoms related to the rectal tumor requiring first intention rectal surgery (appreciated by investigator) * Contra-indication for surgery * Resectable metastases * Complicated (obstruction, bleeding, abscess, perforation) primary tumor requiring emergency surgery and/or contra-indicating first line-chemotherapy * Non-resectable primary tumor (with wild margin) * Age \> 75 years \< 18 years * ECOG performance status \> 2 * Under nutrition (albumin \< 30 g/l) * Peritoneal carcinomatosis * Disease progression under chemotherapy (RECIST 1.1 criteria) * Known hypersensitivity reaction or specific contraindications to any of the components of study treatments * Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia * Pregnancy (absence to be confirmed by ß-hCG test) or breast-feeding; * Previous malignancy in the last 5 years * Medical, geographical, sociological, psychological or legal conditions that would prevent the patient from completing the study or signing the informed consent; in the investigator's opinion * Any significant disease which, in the investigator's opinion, excludes the patient from the study * Under an administrative or legal supervision.
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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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Service d'Oncologie Médicale, Clinique du Cap-d'Or
La Seyne-sur-Mer, 83500, France
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Service de Chirurgie Générale et Digestive, CHRU Claude Huriez
Lille, 59067, France
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Service de Chirurgie Générale et Digestive, Centre hospitalier Lyon Sud, HCL
Pierre-Bénite, France, 69495, France
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