beta
Trial Radar AI
Clinical Trial NCT05378919 (RECTUM2015) for Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer (RECTUM2015) Phase 2 250 Randomized Open-Label

Recruiting
Clinical Trial NCT05378919 (RECTUM2015) is designed to study Treatment for Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX. It is a Phase 2 interventional study that is recruiting, having started on June 1, 2015, with plans to enroll 250 participants. Led by Lithuanian University of Health Sciences, it is expected to complete by June 1, 2027. The latest data from ClinicalTrials.gov was last updated on May 18, 2022.
Brief Summary
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
Detailed Description
This is a biomedical research, phase II, multicenter, open-label, randomized study, comparing neoadjuvant CT with FOLFOX4, versus immediate preoperative chemoradiotherapy (CRT), in patients with locally advanced rectal cancer. Randomization in a 1: 1 ratio, neoadjuvant chemotherapy or chemoradiation. The purpose of the study is to evaluate the efficacy, tolerability, and comparability of new standard preoperative che...Show More
Official Title

Evaluation and Comparison of the Efficacy of a New Standard Pre-operative Chemotherapy for Stage II and III Colorectal Cancer According to the FOLFOX4 Regimen With Routine Chemoradiation Therapy

Conditions
Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX
Other Study IDs
  • RECTUM2015
NCT ID Number
NCT05378919
Start Date (Actual)
2015-06-01
Last Update Posted
2022-05-18
Completion Date (Estimated)
2027-06-01
Enrollment (Estimated)
250
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorArm A (Control): Radiotherapy + fluorouracil
Chemoradiotherapy 5 weeks (50 Grays (Gy), 2 Gy/session; 25 fractions) + fluorouracil/leucovorin 400 mg/m² 1-4 day the first and fifth weeks of radiotherapy) , then 6-8 weeks after chemoradiation, surgery, followed by adjuvant chemotherapy for 4-6 months, either Folfox4 or fluorouracil, depending on the center's choice.
Radiotherapy 50 Gy
Radiotherapy 50 Gy 5 radiations per week of 2 Gy for 5 weeks
Fluorouracil/folic acid
Fluorouracil 400 mg/m² D1-4 and folic acid 20mg/m2 D1-4 the first and fifth weeks of radiotherapy
ExperimentalArm B (Experimental): Chemotherapy with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4) regimen
Neoadjuvant CT FOLFOX4, 8 cycles (ca. 4 months; each cycle = 2 weeks): oxaliplatin: 85 mg/m² in 2 hours at D1; folinic acid: 100 mg/m² simultaneously in 2 hours at D1 and D2 during the Oxaliplatin; bolus 5-fluorouracil (5-FU) 400mg/m² D1+D2; infusion 5-fluorouracil (5-FU): 600 mg/m² continuous infusion during 22hours at D1 and D2, every 14 days during 42 months (8 cycles).
Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4)
oxaliplatin: 85 mg/m² in 2 hours at D1; folinic acid: 100 mg/m² simultaneously in 2 hours at D1 and D2 during the Oxaliplatin; bolus 5-fluorouracil (5-FU) 400mg/m² D1+D2; infusion 5-fluorouracil (5-FU): 600 mg/m² continuous infusion during 22hours at D1 and D2, every 14 days during 42 months (8 cycles).
Radiotherapy 50 Gy
Chemoradiotherapy 5 weeks (50 Grays (Gy), 2 Gy/session; 25 fractions) + fluorouracil/leucovorin 400 mg/m² 1-4 day the first and fifth weeks of radiotherapy. FOLOFX4 will be administrated for 8 cycles over a 16 week period. Patients will undergo re-staging within 6 weeks of their 8th cycle of FOLFOX. This will include MRI of the pelvis. If the reassessment reveals that there has been no disease progression compared t...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
disease-free survival
To compare the 3-year disease-free survival between the investigational arm and the control arm.
3 year
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Overall survival
Overall survival will be defined as the time from randomisation to the time of occurrence of the first death regardless to its cause. Patients alive at the time of analysis will be censored at the date of the last follow up.
7 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
Lithuanian University of Health Sciences logoLithuanian University of Health Sciences
Study Responsible Party
Rita Ambraziene, Principal Investigator, Sub-Investigator, Lithuanian University of Health Sciences
Study Central Contact
Contact: Rita Ambraziene, +37037326196, [email protected]
1 Study Locations in 1 Countries
Rita Ambraziene, Kaunas, 45304, Lithuania
Rita Ambraziene, Contact, 837326196, [email protected]
Contact, [email protected]
Rita Ambraziene, MD, Principal Investigator
Rasa Jančiauskienė, prof, Principal Investigator
Tadas Latkauskas, prof, Sub-Investigator
Laimonas Jaruševičius, assoc.prof, Sub-Investigator
Algimantas Tamelis, prof, Sub-Investigator
Žilvinas Saladžinskas, prof, Sub-Investigator
Irina Gineikienė, phd, Sub-Investigator
Ingrida Pikūnienė, MD, Sub-Investigator
Recruiting