Curative Chemoradiation of Low Rectal Cancer

Rectal Cancer Clinical Trial

— WW2  

Official title:

Curative Chemoradiation of Low Rectal Cancer. A Prospective Multicenter Observational Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02438839
• Other study ID #: WW2
• Status: Active, not recruiting
• Start date: September 2015
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: December 2024
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
Denmark	Department of Oncology, Aalborg University Hospital	Aalborg
Denmark	Department of Surgery, Aalborg University Hospital	Aalborg
Denmark	Department of Oncology, Rigshospitalet	Copenhagen
Denmark	Department of Oncology, Vejle Hospital	Vejle
Denmark	Department of Surgery, Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment		2 years after end of treatment
Secondary	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
Secondary	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
Secondary	Response and tumor control on MRI scans compared to clinical observations, including rectoscopic examination		6 and potentially 12 weeks after end of treatment