Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

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

Trial website

Contact information



Primary contact

Prof Kaja Ludwig


Contact details

Department of Surgery
Klinikum Suedstadt Rostock
Suedring 81

Additional identifiers

EudraCT number

2007-006758-24 number

Protocol/serial number


Study information

Scientific title

NEROP-RC (NEoadjuvant Radiotherapy for Older Patients – Rectal Cancer): a randomised controlled phase III study



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Optimal therapy for patients > 70 years with rectal cancer


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment


Trial participating centre

Klinikum Suedstadt Rostock

Sponsor information


South City Hospital Rostock (Klinikum Suedstadt Rostock) (Germany)

Sponsor details

Department of Surgery
Klinikum Suedstadt Rostock
Suedring 81

Sponsor type

Hospital/treatment centre



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


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

Publication citations

Additional files

Editorial Notes

31/03/2017: Plain English summary added.