Back to results

Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer (RECTUM2015)

Primary Purpose

Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX

Status

Recruiting

Phase

Phase 2

Locations

Lithuania

Study Type

Interventional

Intervention

Radiotherapy 50 Gy

Fluorouracil/folic acid

Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4)

Radiotherapy 50 Gy

About this trial

This is an interventional treatment trial for Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rita AmbrazieneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A (Control): Radiotherapy + fluorouracil

Arm B (Experimental): Chemotherapy with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4) regimen

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

disease-free survival

To compare the 3-year disease-free survival between the investigational arm and the control arm.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05378919

First Posted

May 8, 2022

Last Updated

May 12, 2022

Sponsor

Lithuanian University of Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05378919

Brief Title

Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer

Acronym

RECTUM2015

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2015 (Actual)

Primary Completion Date

June 1, 2025 (Anticipated)

Study Completion Date

June 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lithuanian University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 chemotherapy with FOLFOX4 in patients with stage II and III colorectal cancer compared to routine chemoradiation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoadjuvant Therapy in Rectal Cancer, Radiotherapy, FOLFOX

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A (Control): Radiotherapy + fluorouracil

Arm Type

Active Comparator

Arm Description

Arm Title

Arm B (Experimental): Chemotherapy with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4) regimen

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy 50 Gy

Intervention Description

Radiotherapy 50 Gy 5 radiations per week of 2 Gy for 5 weeks

Intervention Type

Drug

Intervention Name(s)

Fluorouracil/folic acid

Intervention Description

Fluorouracil 400 mg/m² D1-4 and folic acid 20mg/m2 D1-4 the first and fifth weeks of radiotherapy

Intervention Type

Drug

Intervention Name(s)

Chemotherapy in regimen with Oxaliplatin, fluorouracil, folinic acid (FOLFOX4)

Intervention Description

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).

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy 50 Gy

Intervention Description

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 to the pre-treatment evaluation and the patient remains a candidate for an R0 resection, the patient will proceed to definitive rectal cancer surgery within 8 weeks from the last chemotherapy dose. If the surgical oncologist's reassessment reveals that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous fluorouracil.

Primary Outcome Measure Information:

Title

disease-free survival

Description

To compare the 3-year disease-free survival between the investigational arm and the control arm.

Time Frame

3 year

Secondary Outcome Measure Information:

Title

Overall survival

Description

Time Frame

7 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rita Ambraziene

Phone

+37037326196

rita.ambraziene@gmail.com

Facility Information:

Facility Name

Rita Ambraziene

City

Kaunas

ZIP/Postal Code

45304

Country

Lithuania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rita Ambraziene

Phone

837326196

rita.ambraziene@gmail.com

Ext

Ambraziene

rita.ambraziene@gmail.com

First Name & Middle Initial & Last Name & Degree

Rita Ambraziene, MD

First Name & Middle Initial & Last Name & Degree

Rasa Jančiauskienė, prof

First Name & Middle Initial & Last Name & Degree

Tadas Latkauskas, prof

First Name & Middle Initial & Last Name & Degree

Laimonas Jaruševičius, assoc.prof

First Name & Middle Initial & Last Name & Degree

Algimantas Tamelis, prof

First Name & Middle Initial & Last Name & Degree

Žilvinas Saladžinskas, prof

First Name & Middle Initial & Last Name & Degree

Irina Gineikienė, phd

First Name & Middle Initial & Last Name & Degree

Ingrida Pikūnienė, MD

12. IPD Sharing Statement

Learn more about this trial

Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer

We'll reach out to this number within 24 hrs