Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of local recurrence | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of cumulative local recurrence | Up to 5 years | |
| Frequency of distant metastases verified by planned PET/CT scans | Up to 5 years. | |
| Overall survival |
Not provided
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
Normal liver function
Renal function
Written and orally informed consent
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients referred from surgical departments in Denmark.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anders Jakobsen, DMSc | Vejle Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vejle Hospital | Vejle | DK-7100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26156652 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 5 years. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |