Plain English Summary
Background and study aims
Rectal cancer is cancer that starts in the rectum, the lower part of the large bowel. Locally advanced rectal cancer means that the cancer has spread into the tissues around the rectum but hasn’t spread to other organs. The aim of this study is to find out whether it is better to treat patients aged over 70 with radiotherapy before they undergo surgery to remove the cancer.
Who can participate?
Patients aged over 70 with locally advanced rectal cancer who are medically unfit for standard radiochemotherapy treatment
What does the study involve?
Participants are randomly allocated to one of two groups. One group are treated with radiotherapy followed by surgery followed by chemotherapy if tolerated. The other group are treated with surgery followed by chemotherapy. Both groups are followed up to see which treatment has better results.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
South City Hospital Rostock (Klinikum Suedstadt Rostock) (Germany)
When is the study starting and how long is it expected to run for?
January 2013 to January 2021
Who is funding the study?
South City Hospital Rostock (Klinikum Suedstadt Rostock) (Germany)
Who is the main contact?
Prof. Dr med. habil. Kaja Ludwig
kfch@kliniksued-rostock.de
Trial website
Contact information
Type
Scientific
Primary contact
Prof Kaja Ludwig
ORCID ID
Contact details
Department of Surgery
Klinikum Suedstadt Rostock
Suedring 81
Rostock
18059
Germany
-
kfch@kliniksued-rostock.de
Additional identifiers
EudraCT number
2007-006758-24
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
NEROP-RC (NEoadjuvant Radiotherapy for Older Patients Rectal Cancer): a randomised controlled phase III study
Acronym
NEROP-RC
Study hypothesis
The primary aim of the study is to demonstrate the superiority of preoperative radiotherapy (5x5Gy) followed by total mesorectal excision (TME) or abdomino-sacral rectum extirpation in patients over 70 years of age with locally advanced rectal cancer, up to a max. of uT1-3N1-2M0 versus surgery alone with TME or abdomino-sacral rectum extirpation with regard to locoregional control.
Ethics approval
University of Rostock Ethics Commission, 31/05/2010, ref: FK-2010-0008
Study design
Prospective randomised controlled multicentre phase III study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Optimal therapy for patients > 70 years with rectal cancer
Intervention
All patients over 70 years of age and having preoperatively diagnosed locally advanced rectal cancer (uT1-3 and/or uN1-2), for whom the neoadjuvant standard RCT appears to present too high a risk, are randomised to two study arms:
Arm A: neoadjuvant short-term RT (5x5Gy) followed by TME or abdominosacral rectum extirpation
Arm B (control arm): TME alone or abdomino-sacral rectum extirpation.
Four weeks following surgery re-evaluation takes place in both arms if possible, then administration of 5-FU- based Chemotherapy (CT) for 6 months. If no CT is possible, then control arm is followed up.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
Superiority of preoperative radiotherapy (5x5Gy) followed by TME and abdomino-sacral rectum extirpation in patients over 70 years of age with locally advanced rectal cancer up to a maximum of uT1-4N1-2M0 versus surgery alone with TME or abdomino-sacralen rektum extirpation with respect to locoregional control.
Secondary outcome measures
1. Disease-free survival (DFS) (first case of tumor illness locoregional or distant metastases)
2. Occurrence of distant metastases
3. Frequency of other, non-tumor-related deaths
4. Determination for comorbidity based on the Charlson Index and the ADL Index
5. Determination of how often chemotherapy can be performed postoperatively
7. Acute and long-term toxicity of preoperative radiotherapy
8. Overall survival (OS)
Overall trial start date
01/01/2013
Overall trial end date
01/01/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with primary diagnosis of histologically bioptically secured diagnosis of rectal cancer
2. Rectal cancer at any height (up to 16cm lower edge of tumor measured from the anal line using inflexible rectoscopy)
3. Decision made by the treating tumor team that intensified RCT is not possible
4. Preoperative tumor staging max. uT1-4uN1-2M0
5. Age >/= 70 years
6. Karnofsky index >/= 70%
7. ASA-classification < IV
8. Oral and written consent according to
9. Good Clinical Practice and corresponding local, national and international regulations
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
The study was originally designed to include 800 patients, 400 patients in each arm
Participant exclusion criteria
1. Other previous cancer illnesses with the exception of appropriately treated in situ carcinoma of the cervix or skin tumors with no indication of melanoma or in cases of tumor-free state ≥ 10 years subsequent to appearance of cancer which has undergone appropriate treatment
2. Participation in studies elsewhere which include chemotherapy or radiotherapy
3. Inability to participate in regular check-ups
Recruitment start date
01/01/2013
Recruitment end date
01/01/2021
Locations
Countries of recruitment
Germany
Trial participating centre
Klinikum Suedstadt Rostock
Rostock
18059
Germany
Sponsor information
Organisation
South City Hospital Rostock (Klinikum Suedstadt Rostock) (Germany)
Sponsor details
Department of Surgery
Klinikum Suedstadt Rostock
Suedring 81
Rostock
18059
Germany
-
kfch@kliniksued-rostock.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
South City Hospital Rostock (Klinikum Suedstadt Rostock), Department of Surgery (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list