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Status:

ACTIVE_NOT_RECRUITING

No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer

Lead Sponsor:

Servicio de Salud Metropolitano Sur Oriente

Conditions:

Rectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This study is designed to explore the hypothesis that in patients with a Locally advanced rectal cancer (LARC) treated with a Total neoadjuvant therapy (TNT) strategy based on short course radiotherap...

Detailed Description

Non-operative management with a Watch and Wait (W\&W) strategy has been advocated for selected patients with a locally advanced rectal cancer (LARC) and a complete clinical response (cCR) after neoaju...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed diagnosis of adenocarcinoma of the rectum
  • Clinical Stage II (T3-4, N-) or Stage III (any T, N+) based on Magnetic Resonance Imaging (MRI)
  • Tumors \< 7cm from anal verge (palpable)
  • No prior history of rectal cancer
  • Exclusion Criteria
  • Patients with tumors \>7cm from anal verge
  • ECOG \>1,
  • Contraindication for chemotherapy: Hemoglobin \<8, White Blood Count \<4000, Platelets \<100,000, Creatinine Clearance \<50ml/min, Total Bilirubin \<5mg/dl,
  • Stage IV at diagnosis
  • Coronary artery disease, either no treated or recent acute coronary syndrome in the last 12 months.
  • Congestive heart failure
  • Peripheral neuropathy
  • Previous pelvic radiotherapy
  • Prior rectal cancer treatment
  • Pregnancy or nursery
  • Any contraindications to MRI (e.g. patients with pacemakers)
  • Indication of pelvic exenteration
  • Impossibility to consent.

Exclusion

    Key Trial Info

    Start Date :

    June 9 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 1 2026

    Estimated Enrollment :

    73 Patients enrolled

    Trial Details

    Trial ID

    NCT04864067

    Start Date

    June 9 2021

    End Date

    March 1 2026

    Last Update

    July 1 2025

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Complejo Asistencial Doctor Sótero del Rio

    Santiago, RM, Chile

    2

    Hospital La Florida

    Santiago, RM, Chile

    3

    Hospital Padre Hurtado

    Santiago, RM, Chile