Condition category
Cancer
Date applied
06/06/2012
Date assigned
16/10/2012
Last edited
30/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review 4

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

Eudra-CT-Number 2007-006758-24

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 below 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

Drug

Phase

Phase III

Drug names

5-FU

Primary outcome measures

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 (DSF); (first case of tumor illness locoregional or distant metastases)
2. Occurrence of distant metastases
3. Frequency of other, non-tumor-related deaths
4. Determination fo 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

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

http://www.kliniksued-rostock.de

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes