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

NCT07483060 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025-522955-25-00
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

Early rectal cancer; organ preservation; watch and wait; chemoradiotherapy; clinical complete response; quality of life; low anterior resection syndrom

Outcome Measures

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.

  1 year

Secondary Outcomes (10)

• Clinical Complete Response at 3 Years

  3 years

• Local Recurrence Rate

  3 years

• Distant metastases

  3 years

• Overall Survival

  up to 5 years

• Organ Preservation Rate

  3 years

Study Arms (2)

Mesorectal chemoradiotherapy

EXPERIMENTAL

Participants receive mesorectal chemoradiotherapy consisting of radiotherapy (50 Gy in 25 fractions over 5 weeks) combined with capecitabine 825 mg/m² orally twice daily on radiotherapy days. Treatment response is assessed 6-8 weeks after completion using high-resolution MRI, endoscopy, and clinical examination. Participants achieving clinical complete response enter a structured "watch and wait" surveillance program with regular MRI, endoscopy, and clinical follow-up. If incomplete response or tumor regrowth is detected at any time during surveillance, total mesorectal excision (TME) surgery is recommended according to standard of care.

Combination Product: Capecitabine + Radiotherapy

Standard Surgery (Total Mesorectal Excision)

ACTIVE COMPARATOR

Participants undergo upfront total mesorectal excision (TME) according to standard surgical practice and national guidelines for early rectal cancer. The surgical approach (open, laparoscopic, or robotic) is at the discretion of the treating surgeon. No neoadjuvant radiotherapy is administered. Postoperative care and oncologic follow-up are conducted according to national guidelines. Participants contribute clinical, oncologic, and patient-reported outcome data for comparison with the organ preservation arm.

Procedure: Total Mesorectal Excision (TME)

Interventions

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.

Mesorectal chemoradiotherapy

Total Mesorectal Excision (TME) PROCEDURE

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.

Standard Surgery (Total Mesorectal Excision)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Written informed consent
• Biopsy-proven rectal adenocarcinoma
• Tumor located \<12 cm from the anal verge
• MRI-staged T1-T3b tumor
• N0 or NX (no radiologic evidence of nodal metastases)
• M0 or MX (no radiological evidence of distant metastases)
• ECOG performance status 0-1
• Multidisciplinary team (MDT) assessment confirming that both total mesorectal excision (TME) and chemoradiotherapy are feasible treatment options

You may not qualify if:

• MRI-defined N1 or higher nodal disease
• Distant metastases (M1)
• MRI extramural vascular invasion (mriEMVI)
• Threatened mesorectal fascia (≤1 mm on MRI)
• Maximum tumor diameter \> 40 mm
• MRI defined mucinous tumor
• No residual luminal tumor following prior endoscopic resection
• Recurrent rectal cancer
• Prior pelvic radiotherapy
• Uncontrolled significant cardiorespiratory comorbidity
• Known complete dihydropyrimidine dehydrogenase (DPYD) deficiency
• Known Gilbert's syndrome
• Pregnancy or breastfeeding
• Concomitant medication contraindicated with capecitabine that cannot be safely discontinued
• Age \<18 years

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Skane University Hospital: collaborator
• Stockholm South General Hospital: collaborator

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine; Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Therapeutics

Central Study Contacts

Eva Angenete, MD, PhD

CONTACT

+46-31-342-10-00; eva.angenete@gu.se

Jennifer Park, MD, PhD

CONTACT

jennifer.park@gu.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a non-randomized, patient preference-based parallel assignment study. Eligible patients with early rectal cancer are offered a choice between standard upfront total mesorectal excision (TME) surgery and organ preservation with mesorectal chemoradiotherapy. Participants remain in their selected treatment group and are followed prospectively according to the study protocol.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 19, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 1, 2031
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share