Clinical trial NCT02438839: Curative Chemoradiation of Low Rectal Cancer
Official title: Curative Chemoradiation of Low Rectal Cancer. A Prospective Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rectal Cancer
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 105
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 with low rectal cancer (tumor located ≤ 6 cm from the anal verge) who are referred to the participating departments and who fulfill the inclusion criteria.

Brief summary: The aim of the present study is to investigate whether curative chemoradiation of low rectal cancer is feasible, safe and effective in a multicenter study with results comparable to those of single center studies.

Results from previous studies indicate that a considerable fraction of patients with low rectal cancer can be cured by a combination of radiation and chemotherapy alone and thus be spared from operation.


Eligibility criteria: Inclusion Criteria:

* Histopathologically verified adenocarcinoma of the rectum
* Planned abdominoperineal resection (APR) or ultralow resection
* Primary, resectable T1-T3, N0 tumor. N1 nodal disease is acceptable, if the positive lymph nodes are localized to the mesorectum at the level of the tumor.
* Distance from anal verge to lower edge of tumor ≤ 6 cm measured by rigid rectoscope
* Performance status 0-2
* Patient acceptance to collection of biopsies and blood samples for translational research
* Age ≥ 18 years
* Normal function of bone marrow as evaluated by

  * neutrophils ≥ 1.5 x 10\^9/l
  * thrombocytes ≥ 100
* Normal function of liver

  * alanine aminotransferase (ALAT) \< 2.5 x upper limit of normal
  * bilirubin \< 2.5 x upper limit of normal
* Kidney function

  - Serum creatinine \< 1.5 x upper limit of normal or measured glomerular filtration rate (GFR) \> 30 ml/min
* Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment.
* Written and orally informed consent

Exclusion Criteria:

* Previous surgical treatment of the present cancer, including transanal excision of tumor.
* Other malignant disease within the past five years except basocellular skin cancer and carcinoma in situ cervicis uteri
* Distant metastases verified by imaging or biopsy
* Previous radiation treatment of the pelvis
* Pregnant or breastfeeding women

Primary outcomes:
measure: Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment
timeFrame: 2 years after end of treatment
Secondary outcomes:
measure: Cumulative incidence of local recurrence after surgery
timeFrame: Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years
measure: Rate of distant metastases
timeFrame: Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years
measure: Response and tumor control on MRI scans compared to clinical observations, including rectoscopic examination
timeFrame: 6 and potentially 12 weeks after end of treatment
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Oncology, Aalborg University Hospital
city: Aalborg
country: Denmark
facility: Department of Surgery, Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Department of Oncology, Rigshospitalet
city: Vejle
country: Denmark
facility: Department of Oncology, Vejle Hospital
city: Vejle
country: Denmark
facility: Department of Surgery, Vejle Hospital
Study officials:
affiliation: Department of Oncology, Vejle Hospital
name: Anders Jakobsen, DMSc
role: STUDY_CHAIR
affiliation: Department of Oncology, Vejle Hospital
name: Henrik Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: