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

Sponsor
Vastra Gotaland Region
Study ID
NCT07483060
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Mar 19, 2026
Start date
Mar 12, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2031

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mesorectal chemoradiotherapy
    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.
  • Active Comparator: Standard Surgery (Total Mesorectal Excision)
    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.

Primary Outcome Measure

Sustained clinical complete response at 1 year [ Time Frame: 1 year ]

Central Contacts

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