Neoadjuvant short-term radiotherapy followed by surgery versus surgery alone for patients over 70 years of age with local advanced rectal cancer and who are medically unfit for standard neoadjuvant radiochemotherapy treatment

ISRCTN	ISRCTN74475000
DOI	https://doi.org/10.1186/ISRCTN74475000
EudraCT/CTIS number	2007-006758-24
Secondary identifying numbers	N/A

Submission date: 06/06/2012
Registration date: 16/10/2012
Last edited: 31/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Kaja Ludwig
Scientific

Department of Surgery
Klinikum Suedstadt Rostock
Suedring 81
Rostock
18059
Germany

Email	kfch@kliniksued-rostock.de

Study information

Study design	Prospective randomised controlled multicentre phase III study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	NEROP-RC (NEoadjuvant Radiotherapy for Older Patients Rectal Cancer): a randomised controlled phase III study
Study acronym	NEROP-RC
Study objectives	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(s)	University of Rostock Ethics Commission, 31/05/2010, ref: FK-2010-0008
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2013
Completion date	01/01/2021

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	The study was originally designed to include 800 patients, 400 patients in each arm
Key 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
Key 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
Date of first enrolment	01/01/2013
Date of final enrolment	01/01/2021

Locations

Countries of recruitment

Germany

Study participating centre

Klinikum Suedstadt Rostock

Rostock
18059
Germany

Sponsor information

South City Hospital Rostock (Klinikum Suedstadt Rostock) (Germany)
Hospital/treatment centre

Department of Surgery
Klinikum Suedstadt Rostock
Suedring 81
Rostock
18059
Germany

Email	kfch@kliniksued-rostock.de
Website	http://www.kliniksued-rostock.de
"ROR"	https://ror.org/02m0p4y77

Funders

Funder type

Hospital/treatment centre

South City Hospital Rostock (Klinikum Suedstadt Rostock), Department of Surgery (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

31/03/2017: Plain English summary added.