Watchful Waiting. An Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy

Conditions
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Rectal Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of local recurrence |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of cumulative local recurrence |  | Up to 5 years | 
| Frequency of distant metastases verified by planned PET/CT scans |  | Up to 5 years. | 
| Overall survival |  | Up to 5 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Watchful Waiting, Rectal cancer, Observation, Avoid operation