Neoadjuvant Chemotherapy for Locally Advanced Rectal Cancer
Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer
Recruiting
Phase 2Interventional Study
Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
Lithuanian University of Health Sciences · Other
Who this trial is looking for
This trial is looking for patients with stage II or III rectal cancer. Participants will receive a specific type of chemotherapy before surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with rectal adenocarcinoma
I have a measurable tumor size
My general health is rated as ECOG 0-2
I have a stage II or III rectal tumor
My cancer has not spread long-term
My tumor is located 0-15 cm from the anus
I had normal blood tests recently
I can provide signed informed consent
You may not be able to join if
I have signs of intestinal obstruction
I have had previous radiation therapy to the lower abdomen
I have had another tumor in the past five years
I am pregnant or breastfeeding
I do not agree to use contraception if I can become pregnant
I have other health issues that would make me unsuitable for this study
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Phase II, Multicenter, Open-label, Randomized Study evaluating neoadjuvant chemotherapy (FOLFOX4) in patients with stage II and III colorectal cancer with standard chemoradiation Defined by Magnetic Resonance Imaging
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Eligibility Criteria
Inclusion Criteria:
* diagnosed with rectal adenocarcinoma;
* radiologically measurable tumor size;
* general condition (ECOG 0-2 points);
* stage II or III rectal tumor clinically (pelvic MRI and endorectal ultrasound),
* in the absence of long-term spread of the disease (confirmed by radiological…
Inclusion Criteria:
* diagnosed with rectal adenocarcinoma;
* radiologically measurable tumor size;
* general condition (ECOG 0-2 points);
* stage II or III rectal tumor clinically (pelvic MRI and endorectal ultrasound),
* in the absence of long-term spread of the disease (confirmed by radiological examinations (computed tomography of the thorax and abdomen));
* during preoperative proctoscopy, the tumor is detected 0 -15 cm from the anus;
* Blood tests 28 days before the start of treatment:
and general blood count: neutrophils greater than 1.5x10 9 / l, platelets greater than 100 x 10 9 / l, Hemoglobin greater than 80 g / l, liver enzymes (Aspartate aminotransferase (AST/GOT), alanine aminotransferase (ALT/GPT) not more than 3 times upper limit), and renal function (creatinine up to 1.5 times the upper limit of normal) is normal; women of childbearing potential - negative pregnancy test;
• A signed informed consent form.
Exclusion Criteria:
* patients with signs of intestinal obstruction at the start of treatment;
* previous lower abdominal radiation therapy;
* other tumors over a five-year period;
* pregnant or breastfeeding women;
* men and women of childbearing potential who do not agree to use adequate contraception;
* Patient co-morbidities that would make the patient unsuitable for this study or significantly interfere with the assessment of safety and toxicity.
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