- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03280407
NEOadjuvant Chemotherapy Only Compared With Standard Treatment for Locally Advanced Rectal Cancer (NEOLAR)
NEOadjuvant Chemotherapy Only Compared With Standard Treatment for Locally Advanced Rectal Cancer: a Randomized Phase II Trial
The main clinical hypothesis is that compared to radio-chemotherapy for low and mid rectal tumors or surgery for high rectal tumors neoadjuvant chemotherapy reduces the rate of distant relapse without increasing the rate of local relapse.
The aim of the present study is to compare long term and short term outcomes in rectal cancer patients undergoing standard treatment (radio-chemotherapy/surgery) or experimental neoadjuvant chemotherapy/surgery Furthermore, early surgical and medical complications, the functional outcome, toxicity and quality of life (QoL) may be improved if radiotherapy can be avoided.
Exploratory analyses are planned in order to find potential predictive markers for selecting patients to either radio-chemotherapy/surgery or neoadjuvant combination chemotherapy/surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Ismail Gögenur, MD
- Phone Number: +45 26336426
- Email: igo@regionsjaelland.dk
Study Contact Backup
- Name: Lars Henrik Jensen, MD
Study Locations
-
-
-
Vejle, Denmark
- Recruiting
- Vejle Hospital
-
Contact:
- Lars Henrik Jensen, MD PhD
- Email: lars.henrik.jensen@rsyd.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adenocarcinoma of the rectum with the lower boarder within 15 cm from the anal verge
- Locally advanced tumor based on imaging
- T3 tumors within 10 cm from the anal verge fulfilling the criteria for preoperative radio-chemotherapy according to Danish Colorectal Cancer Group (DCCG) guidelines
- T3c or T4 tumors 10-15 cm from the anal verge
- Deemed resectable at the multidisciplinary team (MDT) conference
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Age at least 18 years
- Adequate bone marrow, liver and renal function allowing systemic chemotherapy
- Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l.
- Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value
- Calculated or measured renal glomerular filtration rate at least 30 mL/min
- Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable
- Written and orally informed consent
Exclusion Criteria:
- Distant metastasis
- Invasive ingrowth into other organs
- Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy
- Previous radiotherapy to the pelvis
- Previous treatment with 5FU or oxaliplatin
- Surgery within two weeks
- Neuropathy NCI grade > 1
- Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri
- Pregnant (positive pregnancy test) or breast feeding women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A, capecitabine
Radiochemotherapy with 50.4 Gy in 28 fractions concomitantly with chemotherapy
|
Radio-chemotherapy with 50.4 Gy in 28 fractions to tumor and regional lymph nodes concomitantly with capecitabine 825 mg/m2 b.i.d
|
Experimental: B, FOLFOX or CAPOX
Neoadjuvant chemotherapy with CAPOX (oxaliplatin/capecitabine) or FOLFOX regimen (oxaliplatin/leucovorin/5FU), according to institutional practice
|
Six cycles: Oxaliplatin 85 mg/m2 day 1, leucovorin 400 mg/m2 day 1, 5FU 400 mg/m2 bolus day 1 and 5FU 2400 mg/ m2 over 46-48 hours day 1-3, repeated every two weeks.
Other Names:
Four cycles: Oxaliplatin 130 mg/m2 day 1 and capecitabine 1000 mg/m2 b.i.d.
days 1-14, repeated every 3 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease free survival
Time Frame: 5 years
|
All patients will be evaluated with CT and MRI scans and clinically every 6 months for 2 years and annually until the number of events is reached and the trial is stopped (max 5 years)
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 5 years
|
All patients will be evaluated with CT and MRI scans and clinically every 6 months for 2 years and annually for maximum 5 years
|
5 years
|
Local relapse
Time Frame: 5 years
|
Defined to be within the pelvis.
Any relapse should be verified by biopsy
|
5 years
|
Distant relapse
Time Frame: 5 years
|
Defined to be outside the pelvis.
Any relapse should be verified by biopsy
|
5 years
|
Early toxicity
Time Frame: 5 years
|
Evaluated using CTCEA (Common Terminology Criteria for Adverse Events) version 4.
|
5 years
|
Late toxicity
Time Frame: 5 years
|
Evaluated using CTCEA version 4.
|
5 years
|
Functional outcome
Time Frame: 5 years
|
Measured with LARS questionnaire
|
5 years
|
Quality of life (QoL)
Time Frame: 5 years
|
Measured with EORTC QoL questionnaire
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ismail Gögenur, MD, Department of Surgery, ZUH
- Principal Investigator: Lars Henrik Jensen, MD, Vejle Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Rectal Diseases
- Neoplasms
- Colorectal Neoplasms
- Rectal Neoplasms
- Intestinal Diseases
- Intestinal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Protective Agents
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Capecitabine
- Oxaliplatin
- Leucovorin
- Levoleucovorin
Other Study ID Numbers
- S-20160158
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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