Curative Chemoradiation of Low Rectal Cancer

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Oncology, Aalborg University Hospital, Aalborg, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment

Time frame: 2 years after end of treatment

Secondary outcomes

Cumulative incidence of local recurrence after surgery

Time frame: 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

Time frame: 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

Time frame: 6 and potentially 12 weeks after end of treatment

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

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

Acronym: WW2

Important dates

Study start: 2015
Primary completion: 2022
Study completion: 2026
First posted: May 8, 2015
Registry last updated: Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, not recruiting