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

Conditions

Rectal Cancer

Keywords

Watchful Waiting, Rectal cancer, Observation, Avoid operation

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.

Caroline Brenner Thomsen, Rikke Fredslund Andersen, Lars Henrik Jensen, Anders Jakobsen, Torben Frøstrup Hansen

Gastrointestinal Disorders2020-10-14

10.3390/gidisord2040034

The clinical impact of MicroRNA-21 in low rectal cancers treated with curative radiotherapy in the organ preserving setting.

Torben Frøstrup Hansen, Caroline Brenner Thomsen, Rikke Fredslund Andersen, Lars Henrik Jensen, Anders Jakobsen

Journal of Clinical Oncology2020-05-20

10.1200/jco.2020.38.15_suppl.e16120

Long-term outcomes after high-dose chemoradiotherapy for non-surgical management of distal rectal cancer.

Edina Dizdarevic, Ane Appelt, Torben Frøstrup Hansen, John Ploeen, Henrik Jensen et al. (8 authors)

Journal of Clinical Oncology2019-05-201 citations

10.1200/jco.2019.37.15_suppl.3611

High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study.

Appelt AL, Pløen J, Harling H, Jensen FS, Jensen LH, Jørgensen JC, Lindebjerg J, Rafaelsen SR, Jakobsen A.

2015-07-05361 citations

10.1016/s1470-2045(15)00120-5

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Frequency of local recurrence	1 year

Secondary

Measure	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	Up to 5 years.

Countries

Denmark

Outcome results