Clinical trial NCT00952926: Watchful Waiting. An Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
Official title: A Prospective Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: Watchful Waiting
Rectal cancer
Observation
Avoid operation
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred from surgical departments in Denmark.

Brief 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.

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 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

Primary outcomes:
measure: Frequency of local recurrence
timeFrame: 1 year
Secondary outcomes:
measure: Frequency of cumulative local recurrence
timeFrame: Up to 5 years
measure: Frequency of distant metastases verified by planned PET/CT scans
timeFrame: Up to 5 years.
measure: Overall survival
timeFrame: Up to 5 years.
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: Vejle Hospital
name: Anders Jakobsen, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Appelt AL, Ploen J, Harling H, Jensen FS, Jensen LH, Jorgensen JC, Lindebjerg J, Rafaelsen SR, Jakobsen A. High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study. Lancet Oncol. 2015 Aug;16(8):919-27. doi: 10.1016/S1470-2045(15)00120-5. Epub 2015 Jul 5.