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Selective Neoadjuvant Therapy of Rectal Cancer Patients: SELREC - a randomized controlled, open, multicentre non-inferiority trial

Organizational Data

DRKS-ID:
DRKS00030567
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2023-03-31
Last update in DRKS:
2023-05-05
Registration type:
Prospective

Acronym/abbreviation of the study

SELREC

URL of the study

No Entry

Brief summary in lay language

In patients with a malignant tumour of the middle and lower third of the rectum (rectal cancer), the recommended treatment is radio-chemotherapy before surgery (hereafter referred to as neoadjuvant) and surgical removal of this part of the rectum and all surrounding lymph nodes (rectal resection with total mesorectal excision, TME). Several studies have shown that irradiation with chemotherapy prior to surgery reduces local tumour recurrence. Nevertheless, no improvement in long-term survival (5 years after primary treatment) has been demonstrated. Further studies demonstrated the following in selected patients with rectal cancer that was at least 1mm from the envelope layer surrounding the rectum on cross-sectional imaging (MRI): Direct surgery (rectal resection with total mesorectal excision, TME as described above) was similarly effective to the therapeutic approach of neoadjuvant radiation with chemotherapy followed by surgery. This is an important finding because neoadjuvant radiation with chemotherapy can lead to impairment of the sphincter muscle at the anus and sexual function. This can result in faecal incontinence and disruption of sexual activity. Many patients could be spared these side effects if surgery alone were as effective for the course of the disease as a combination of neoadjuvant radiation and chemotherapy followed by surgery. Currently, we assume that omitting neoadjuvant radiation with chemotherapy will only benefit the course of the patient's disease. The prerequisite for this is that surgery is performed to the required extent, i.e., the envelope layer surrounding the rectum is completely removed to prevent local recurrence of the tumour. However, whether omitting neoadjuvant therapy is not detrimental to patients in the long term regarding local tumour recurrence has not yet been adequately investigated in studies. The SELREC study aims to answer this question. It is planned to enrol a total of 1074 patients in this study. These will be randomly assigned to one of the two treatment groups. The most important aim of the study (primary endpoint) is to clarify in how many patients a tumour recurs within three years (local recurrence). In addition, side effects, questions about sphincter function and quality of life are recorded.

Brief summary in scientific language

Current guidelines recommend neoadjuvant therapy (radiation or combined radiochemotherapy) for the routine treatment of patients with locally advanced rectal cancer. According to previous literature, this treatment strategy results in a lower local recurrence rate, but without improving overall patient survival. In addition, neoadjuvant treatment carries the risk of side effects and is associated with impaired postoperative bowel, bladder, and sexual organ function, particularly fecal incontinence and impotence, which may lead to reduced quality of life. The objective of the SELREC trial is to demonstrate that forgoing neoadjuvant therapy in selected patients with locally advanced rectal cancer and low risk of recurrence based on preoperative MRI characteristics, is non-inferior to a general use of neoadjuvant radiochemotherapy in these patients. A total of 1,074 patients will be randomized to the intervention (total mesorectal excision only) or control (neoadjuvant radiochemotherapy followed by total mesorectal excision) group. The primary endpoint is local recurrence rate within 3 years after surgery. Secondary endpoints include functional outcome, quality of life, 3-year overall survival. If our hypothesis is proven, practice-changing implications can be expected.

Health condition or problem studied

ICD10:
C20 - Malignant neoplasm of rectum
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
TME (total mesorectal excision): open or minimally-invasive surgery (laparoscopic or robotic) in terms of low anterior resection or abdomino-perineal resection with dissection of the rectum and all pararectal lymph nodes within the mesorectal envelope; duration: 3-6h.
Arm 2:
Guideline-compliant neoadjuvant (chemo)radiotherapy (n(C)RT) according to the German S3-guideline followed by open or minimally-invasive surgery (laparoscopic or robotic) in terms of low anterior resection or abdomino-perineal resection with TME (total mesorectal excision) performed up to twelve weeks after the end of n(C)RT.

Endpoints

Primary outcome:
Local recurrence within three years after surgery
Secondary outcome:
major low anterior resection syndrome (LARS), overall survival, perioperative morbidity, perioperative mortality, quality of life, functional socres (urinary and sexual)

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Heidelberg

Recruitment period and number of participants

Planned study start date:
2023-04-01
Actual study start date:
2023-05-04
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
1074
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
- Primary adenocarcinoma of the rectum <12cm from the anal verge - T3 and/or N1 disease - CRM >1mm (MRI based) - No evidence of distant metastasis (M0) - Age ≥18 years - Ability of patient subject to understand character and individual consequences of the clinical trial - Written informed consent

Exclusion Criteria

- Patients who should not receive multimodal treatment for safety reasons - Patients needing neoadjuvant treatment for sphincter preservation - Previous radiotherapy to the small pelvis - Patients with extensive lymph node spread (N2) - Extramural vascular invasion or tumour deposits - Participation in another interventional trial with interference of intervention and/or outcome of this trial - Previous diagnosis of malignant disease except basal cell carcinoma - Contraindications for MRI (e.g. non-MRI-compatible cardiac pacemaker) - Pregnancy or lactation - Any condition that could result in an undue risk for the patient based on the investigator’s assessment

Addresses

Primary Sponsor

Universitätsklinikum Heidelberg; Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
PD Dr. med. Rosa Klotz
Im Neuenheimer Feld 420
69120 Heidelberg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum Heidelberg, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
PD Dr. med. Rosa Klotz
Im Neuenheimer Feld 420
69120 Heidelberg
Germany
Telephone:
+49 6221 56 37426
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universitätsklinikum Heidelberg, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
PD Dr. med. Rosa Klotz
Im Neuenheimer Feld 420
69120 Heidelberg
Germany
Telephone:
+49 6221 56 37426
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universitätsklinikum Heidelberg, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
PD Dr. med. Rosa Klotz
Im Neuenheimer Feld 420
69120 Heidelberg
Germany
Telephone:
+49 6221 56 37426
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Bundesministerium für Bildung und Forschung
Kappelle-Ufer 1
10117 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.bmbf.de

Ethics Committee

Address Ethics Committee

Ethikkommission der Medizinischen Fakultät Heidelberg
Alte Glockengießerei 11/1
69115 Heidelberg
Germany
Telephone:
+49-6221-338220
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2023-01-31
Ethics committee number:
S-059/2023
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-03-07

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
Anonymous data will be made publicly available (in an appropriate data repository) for re- and meta-analyses after completion of the trial upon request.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry