Curative Chemoradiation of Low Rectal Cancer

Active, not recruiting

• Conditions: Rectal Cancer

• Registration Number: NCT02438839
• Lead Sponsor: Vejle Hospital

Brief Summary

The aim of the present study is to investigate whether curative chemoradiation of low rectal cancer is feasible, safe and effective in a multicenter study with results comparable to those of single center studies.

Results from previous studies indicate that a considerable fraction of patients with low rectal cancer can be cured by a combination of radiation and chemotherapy alone and thus be spared from operation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-05
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-08
• Study Start: 2015-09
• Primary Completion: 2022-03-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Histopathologically verified adenocarcinoma of the rectum

• Planned abdominoperineal resection (APR) or ultralow resection

• Primary, resectable T1-T3, N0 tumor. N1 nodal disease is acceptable, if the positive lymph nodes are localized to the mesorectum at the level of the tumor.

• Distance from anal verge to lower edge of tumor ≤ 6 cm measured by rigid rectoscope

• Performance status 0-2

• Patient acceptance to collection of biopsies and blood samples for translational research

• Age ≥ 18 years

• Normal function of bone marrow as evaluated by

  • neutrophils ≥ 1.5 x 10^9/l
  • thrombocytes ≥ 100

• Normal function of liver

  • alanine aminotransferase (ALAT) < 2.5 x upper limit of normal
  • bilirubin < 2.5 x upper limit of normal

• Kidney function

  • Serum creatinine < 1.5 x upper limit of normal or measured glomerular filtration rate (GFR) > 30 ml/min

• Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment.

• Written and orally informed consent

Exclusion Criteria

• Previous surgical treatment of the present cancer, including transanal excision of tumor.
• Other malignant disease within the past five years except basocellular skin cancer and carcinoma in situ cervicis uteri
• Distant metastases verified by imaging or biopsy
• Previous radiation treatment of the pelvis
• Pregnant or breastfeeding women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment	2 years after end of treatment

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of local recurrence after surgery	Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years
Rate of distant metastases	Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years
Response and tumor control on MRI scans compared to clinical observations, including rectoscopic examination	6 and potentially 12 weeks after end of treatment

Trial Locations

Locations (5)

Department of Oncology, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Department of Oncology, Vejle Hospital; 🇩🇰 Vejle, Denmark

Department of Oncology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Department of Surgery, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Department of Surgery, Vejle Hospital; 🇩🇰 Vejle, Denmark