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Next Generation STAR-TREC (NG-ST) - Organ Preservation in Early Rectal Cancer

ConditionRectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region

About this trial

This study evaluates whether mesorectal chemoradiotherapy with a limited radiation target volume can achieve a sustained clinical complete response in patients with early-stage rectal cancer, allowing surgery to be safely deferred. Patients may choose between standard total mesorectal excision (TME) surgery or organ preservation with chemoradiotherapy followed by structured surveillance. The study aims to assess oncologic safety, organ preservation rates, and quality of life.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Written informed consent

Biopsy-proven rectal adenocarcinoma

Tumor located <12 cm from the anal verge

Disqualifiers

MRI-defined N1 or higher nodal disease

Distant metastases (M1)

MRI extramural vascular invasion (mriEMVI)

Threatened mesorectal fascia (≤1 mm on MRI)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Capecitabine + Radiotherapy

    Combination product

    Capecitabine is administered orally at a dose of 825 mg/m² twice daily on radiotherapy treatment days (5 days per week) during the 5-week course of mesorectal radiotherapy. External beam radiotherapy is delivered to the primary tumor and surrounding mesorectum at a total dose of 50 Gy in 25 fractions (2 Gy per fraction), administered once daily, 5 days per week, over approximately 5 weeks, according to protocol-defined target volumes.

  • Total Mesorectal Excision (TME)

    Procedure/Surgery

    Total mesorectal excision (TME) is performed according to standard surgical practice for rectal cancer. The surgical approach (open, laparoscopic, or robotic) is determined by the treating surgeon in accordance with local guidelines.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Mesorectal chemoradiotherapyExperimental treatment 1 intervention
Group B: Standard Surgery (Total Mesorectal Excision)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sustained clinical complete response at 1 year

Proportion of participants in the organ preservation arm who achieve a clinical complete response (cCR) and remain without surgical resection at 1 year after initiation of treatment. Clinical complete response is defined by absence of residual tumor on MRI, no visible tumor on endoscopy (scar/fibrosis permitted), and no palpable tumor on clinical examination.

Time frame
1 year

Secondary outcomes

1

Clinical Complete Response at 3 Years

Proportion of participants achieving and maintaining clinical complete response without surgical resection at 3 years.

Time frame
3 years
2

Local Recurrence Rate

Proportion of participants developing local recurrence after initial treatment.

Time frame
3 years
3

Distant metastases

Proportion of participants developing distant metastatic disease.

Time frame
3 years
4

Overall Survival

Overall survival measured from study inclusion to death from any cause.

Time frame
up to 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vastra Gotaland Region

Lead sponsor

Skane University Hospital

Collaborator

Stockholm South General Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: