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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952926
• Other study ID #: WW
• Status: Completed
• Start date: October 2009
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2019
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
Denmark	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	Frequency of local recurrence		1 year
Secondary	Frequency of cumulative local recurrence		Up to 5 years
Secondary	Frequency of distant metastases verified by planned PET/CT scans		Up to 5 years.
Secondary	Overall survival		Up to 5 years.