This trial is active, not recruiting.

Condition rectal cancer
Sponsor Vejle Hospital
Start date September 2009
End date January 2014
Trial size 100 participants
Trial identifier NCT00952926, S-20090063


The purpose of this study is to investigate if operation and permanent stoma can be omitted in patients with cancer in the lower part of the rectum.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Frequency of local recurrence
time frame: 1 year

Secondary Outcomes

Frequency of cumulative local recurrence
time frame: Up to 5 years
Frequency of distant metastases verified by planned PET/CT scans
time frame: Up to 5 years.
Overall survival
time frame: Up to 5 years.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histopathologically verified adenocarcinoma in the rectum - Planned APR or ultra low resection - Primary resectable T2 or T3 tumor - Distance from anus to lower edge of tumor ≤ 6 cm - Suited for curative intended radiation and chemotherapy - Accept taking of biopsy and blood samples for translational research - Age ≥ 18 years - Normal function of bone marrow - leukocytes ≥ 3 x 10^9/l - thrombocytes ≥ 100 - Normal liver function - ALAT < 2.5 x upper normal value - bilirubin < 2.5 x upper normal value - Renal function - Serum creatinin < 1.5 x upper normal value - Written and orally informed consent Exclusion Criteria: - Other malignant disease within the last 5 years apart from basocellular skin cancer and carcinoma in situ cervicis uteri - Distant metastases - Pregnant or breast feeding patients

Additional Information

Official title A Prospective Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
Description Patients entering this study are offered the possibility of avoiding an extensive operation and a permanent stoma. Over the past 2 years Vejle Hospital examined patients with rectal cancer during their course of treatment and we have developed a method to predict complete response. Patients in this study are treated with chemotherapy and external irradiation supplemented with an endorectal boost (2 fractions). At the start of treatment and weeks 2, 4, and 6 of the treatment course an endoscopy is performed to evaluate the response. The final evaluation is performed 6 weeks after end of treatment. Patients with complete remission are offered observation. Patients with residual tumor are advised to be operated. Follow-up is performed every 2 months the first year and every 3 months the second year. 2 follow-up visits are planned for the third year. A yearly follow-up is scheduled for the fourth and fifth year.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Vejle Hospital.