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

18 Years
Open (Enrolling)
Rectal Cancer

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Trial Information

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

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.

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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Frequency of local recurrence

Outcome Time Frame:

1 year

Safety Issue:



Denmark: National Board of Health

Study ID:




Start Date:

September 2009

Completion Date:

Related Keywords:

  • Rectal Cancer
  • Watchful Waiting
  • Rectal cancer
  • Observation
  • Avoid operation
  • Rectal Neoplasms