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

This study is currently recruiting participants.
Verified December 2012 by Vejle Hospital
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT00952926
First received: August 3, 2009
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition
Rectal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Frequency of local recurrence [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of cumulative local recurrence [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Frequency of distant metastases verified by planned PET/CT scans [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients referred from surgical departments in Denmark.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952926

Contacts
Contact: Anders Jakobsen, DMsc +45 7940 6010 anders.jakobsen@slb.regionsyddanmark.dk
Contact: John Ploeen, MD +45 7940 6016 john.ploeen.mortensen@slb.regionsyddanmark.dk

Locations
Denmark
Vejle Hospital Recruiting
Vejle, Denmark, DK-7100
Contact: Anders Jakobsen, Prof., DMSc         anders.jakobsen@slb.regionsyddanmark.dk    
Principal Investigator: Anders Jakobsen, Prof., DMSc            
Sub-Investigator: John Ploen, MD            
Sponsors and Collaborators
Vejle Hospital
  More Information

No publications provided

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT00952926     History of Changes
Other Study ID Numbers: S-20090063
Study First Received: August 3, 2009
Last Updated: December 10, 2012
Health Authority: Denmark: National Board of Health
Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Vejle Hospital:
Watchful Waiting
Rectal cancer
Observation
Avoid operation

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013