Next generation StaR-TREC

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vaestra Goetalandsregionen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-01-09

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective of this trial is to achieve a sustained clinical complete response rate in
patients 1 year after treatment.

Secondary objectives 3

1. Oncologic safety
2. Treatment related safety
3. Functional outcome including quality of life (QoL)

Conditions and MedDRA coding

Rectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. The subject has given their written consent to participate in the trial
2. Be 18 years or older
3. Have an adenocarcinoma verified tumour within the rectum below 12 cm from anal verge
4. Have a tumour stage of TX/T1-3b (regardless of tumour size)
5. Have no nodal metastases (NX/N0)
6. Have no distant metastases (MX/M0)
7. Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
8. For female subjects of childbearing potential: Have a negative pregnancy test within 7 days prior to study entry and Agree to use adequate, medically approved, contraceptive precautions from trial entry until 6 months after the end of study treatment
9. If non-sterilised male with a partner of childbearing potential, must: Agree to use adequate, medically approved, contraceptive precautions from trial entry until 6 months after the end of study treatment

Exclusion criteria 18

1. Give no informed consent
2. No biopsy confirmed rectal cancer (adenocarcinoma)
3. Have a recurrent rectal cancer
4. An age below 18
5. Have concomitant or previous malignancies within 3 years prior to trial entry, except those that in the opinion of the MDT are unlikely to relapse within 3 years or lead to death within 5 years
6. Have unequivocal evidence of metastatic disease (includes respectable metastases)(Patients with equivocal radiological lesions (e.g. retroperitoneal, liver, lung) that are not classified as M1 are eligible if agreed by MDT)
7. Have an MRI node positive tumour (≥N1, defined by protocol guidelines) (Patients with equivocal radiological findings that are either classified as NX or N0 are eligible)
8. Have MRI extramural vascular invasion (mriEMVI) positive (defined by protocol guidelines)
9. Have a threatened mesorectal fascia (≤1 mm on MRI or ERUS)
10. Have no residual luminal tumour following endoscopic resection prior to first visit at surgical department
11. Have contraindications to radiotherapy including previous pelvic radiotherapy
12. Have uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction or arrhythmia within 6 months prior to trial entry)
13. Have known complete dihydropyrimidine dehydrogenase (DPYD) deficiency
14. Have known Gilbert’s disease (hyperbilirubinemia)
15. Have been taking coumarin-derivative anticoagulants (e.g. warfarin) that cannot be discontinued at least 7 days prior to starting treatment or substituted by low molecular weight heparin
16. Are taking metronidazole, phenytoin or sorivudine or its chemically related analogues, such as brivudine, within 4 weeks of trial entry (see Section 8.3.5 for further details)
17. Are Pregnant or lactating woman
18. Have history of severe and unexpected reactions to fluoropyrimidine therapy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Ratio of patients with a non-operative approach at onset that after evaluation by a combination of MRI, clinical and endoscopic examination have a clinical complete response at 1 year.

Secondary endpoints 13

1. Local recurrence
2. Local regrowth
3. Survival (overall)
4. Metastases
5. Organ preservation rate
6. Clinical complete response rate
7. Morbidity measured with Comprehensive Complications Classification Index (41)
8. Total length of hospital stay
9. Radical resection (R0) after surgery
10. Urinary function
11. Sexual function
12. Bowel function
13. Presence of a stoma

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vaestra Goetalandsregionen

Sponsor organisation

Vaestra Goetalandsregionen

Address

Regionens Hus

City

Vaenersborg

Postcode

462 80

Country

Sweden

Scientific contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Eva Angenete

Public contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Eva Angenete

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications