Rectal Cancer
Conditions
Keywords
rectal cancer, radiotherapy, overall survival, recurrence rate, downstaging
Brief summary
The purpose of this study is to establish the influence of time-interval between preoperative hyperfractionated radiotherapy (5x5 Gy) and surgery on long term overall survival (5 years), local and distant recurrence rate, downstaging rate, sphincter saving procedures, radical resection rate (R0) in patients with locally advanced rectal cancer operated on according to TME technique. In particular 3D endosonography and 3rd generation ultrasonic contrast agents are evaluated to assess response to radiotherapy.
Detailed description
The treatment group comprises patients with locally advanced rectal cancer who were operated on in the 1st Department of General Surgery, Jagiellonian University, Cracow. The data on survival has been systematically collected using national census registry. Patients are qualified to preoperative radiotherapy 5x5 Gy and then randomly assigned to subgroups with different time interval between radiotherapy and surgery: one subgroup consists of patients operated on 7-10 days after the end of irradiation, the second subgroup consists of patients operated on after 4-5 weeks. Both should be homogenous in sex, age, cancer stage and localization, distal and circumferential resection margins, number of resected lymph nodes. 3D endorectal ultrasound and endorectal ultrasound with SonoVue are performed to assess the tumor before and after preoperative radiotherapy.
Interventions
RADIATIONPreoperative radiotherapy
Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)
PROCEDURESurgery
Total mesorectal excision of rectal cancer
Sponsors
Jagiellonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histologically confirmed rectal cancer * tumor localised in middle or lower rectum * age \> 18 years * locally advanced cancer
Exclusion criteria
* previous pelvis radiotherapy * lack of patient's consent * lack of possibility to begin radiotherapy during 14 days after inclusion to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| local and systemic recurrence rate | 5 years | Rate of local and sytemic recurrences in patients included to the protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| radical resections rate (R0) | 1 month | Rate of R0, R1 and R2 procedures according to Hermanek. |
| sphincter saving (sparing) procedures | 1 month | Rate of sphincter saving operations in both arms. |
| overall survival | 5 years | Overall survival and disease specific survival at 5 years follow-up |
| downstaging of rectal cancer | 1 month | Downstaging of the rectal cancer after preoprearite radiotherapy - assessed by comparison of preoperative ERUS, 3D ERUS, contrast enhanced ERUS and postoperative histologic staging |
Countries
Poland
Outcome results
None listed