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Compares treatment options for Rectal Cancer
Official title Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT04495088
What this study is testing
What is mFOLFOX (neoadjuvant)?
mFOLFOX (neoadjuvant) is an investigational medicine, being studied as a potential treatment for rectal cancer.
Also referred to as Folinic acid, Oxaliplatin, 5-FU.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, prospective, randomized, stratified, controlled, open-label study comparing preoperative FOLFOX versus postoperative risk-adapted chemotherapy in patients with locally advanced rectal cancer and low risk for local failure
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localised 0 - 16 cm from the anocutaneous line as measured...
- Staging requirements: High-resolution magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
- Transrectal endoscopic ultrasound (EUS) is used to help discriminate between T1/2 and early T3 tumors.
- MRI-defined i. Lower third (0-6 cm):
- cT1/2 with clear cN+ based on defined MRI criteria or T3a-b (i.e. maximum infiltration into the perirectal fat of 5mm), provided CRM \> 2mm and...
You likely can't join if
- Distant metastases (to be excluded by CT scan of the thorax and abdomen).
- Prior antineoplastic therapy for rectal cancer.
- Prior radiotherapy of the pelvic region.
- Major surgery within the last 4 weeks prior to inclusion.
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- Subject (male or female) is not willing to use highly effective\ \ \ methods of contraception during treatment and for 6 months (male or female)...
See the full eligibility criteria
- Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localised 0 - 16 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower, middle and upper third of the...
- Staging requirements: High-resolution magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
- Transrectal endoscopic ultrasound (EUS) is used to help discriminate between T1/2 and early T3 tumors.
- MRI-defined i. Lower third (0-6 cm):
- cT1/2 with clear cN+ based on defined MRI criteria or T3a-b (i.e. maximum infiltration into the perirectal fat of 5mm), provided CRM \> 2mm and EMVI-\ \ ii. Middle third (≥ 6-12 cm):
- cT1/2 with clear cN+ provided CRM- and EMVI-\ \
- cT3 irrespective of the depth of invasion into the perirectal fat, provided no evidence that tumor is adjacent to (defined as within 2 mm of) the mesorectal fascia on MRI (i.e. CRM \> 2 mm), N0 or N1, EMVI-\ \ iii...
- cT1/2 with clear cN+, irrespective of CRM and EMVI
- any cT3-4 irrespective of nodal status, CRM and EMVI.
- Spiral-CT of the abdomen and chest to exclude distant metastases.
- Aged at least 18 years. No upper age limit.
- WHO/ECOG Performance Status ≤1.
- Adequate haematological, hepatic, renal and metabolic function parameters:
- Leukocytes ≥ 3.000/mm³, ANC ≥ 2.000/mm³, platelets ≥ 100.000/mm³, Hb \> 9 g/dl
- Serum creatinine ≤ 1.5 x upper limit of normal
- Bilirubin ≤ 2.0 mg/dl, SGOT-SGPT, and AP ≤ 3 x upper limit of normal.
- QTc interval (Bazett\ \ ) ≤ 440 ms
- Informed consent of the patient. "\ \ " Formula for QTc interval calculation (Bazett): QTc= ((QT) ̅" (ms)" )/√(RR (sec))= ((QT) ̅" (ms)" )/√(60/(frequency (1/min)))
- Distant metastases (to be excluded by CT scan of the thorax and abdomen).
- Prior antineoplastic therapy for rectal cancer.
- Prior radiotherapy of the pelvic region.
- Major surgery within the last 4 weeks prior to inclusion.
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- Subject (male or female) is not willing to use highly effective\ \ \ methods of contraception during treatment and for 6 months (male or female) after the end of treatment Male patients treated with Oxaliplatin should...
- On-treatment participation in a clinical study in the period 30 days prior to inclusion.
- Previous or current drug abuse.
- Other concomitant antineoplastic therapy.
- Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections, active, disseminated coagulation disorder.
- Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrolment.
- Chronic diarrhea (\> grade 1 according NCI CTCAE).
- Prior or concurrent malignancy ≤ 3 years prior to enrolment in study (Exception: non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1), if the patient is continuously disease-free.
- Known allergic reactions or hypersensitivity on study medication or to any of the other excipients.
- Evidence of peripheral sensory neuropathy \> grade 1 according to CTCAE version 5.0 (see appendix).
- Severe kidney dysfunction (creatinine clearance \< 30 ml/min).
- Recent or concurrent treatment with brivudine.
- Pernicious or other megaloblastic anaemia caused by vitamin B12 deficiency.
- Known dihydropyrimidine dehydrogenase deficiency.
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration...
The study team makes the final eligibility decision.
Where it's taking place
- Mannheim, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mannheim, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.