Rectal Cancer
Conditions
Keywords
rectal cancer, total neoadjuvant therapy, colorectal disease
Brief summary
This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.
Detailed description
In this randomized, controlled, parallel study we will comparison total neoadjuvant therapy with standard neoadjuvant therapy in rectal cancer treatment. Complete pathological response rate will be the primary endpoint in patients, who will undergoing surgery. In cases of complete clinical response we will provide watch and wait approach. Compliance of treatment and oncologic results will be the second endpoint.
Interventions
COMBINATION_PRODUCTConcurrent Chemoradiotherapy
50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d
PROCEDURETME
Total mesorectal excision
Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 3 courses, 3 weeks per course
DRUGadjuvant chemotherapy
Administration of l-LV (400 mg/m2) and oxaliplatin (85 mg/ m2) by intravenous infusion over 2 h, followed by rapid intravenous infusion (iv) of 5-FU (400 mg/m2) and then slow infusion (civ) of 5-FU (2400 mg/m2 over 46 h), is repeated every 2 weeks for 6-12 cycles
Sponsors
State Scientific Centre of Coloproctology, Russian Federation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have signed an approved informed consent form for the stud; * Histologically confirmed rectal adenocarcinoma low (cT2-4N0-2M0) or mid rectum (сТ2-T4N1-2M0);
Exclusion criteria
* rectal cancer recurrence; * Primary-multiple tumours of other localizations; * pelvis radiotherapy in anamnesis; * pregnancy, breastfeeding; * distant metastasis; * ECOG score 3-4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of complete responses | 3-6 months | The rate of pathological or clinical complete responses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of R0-resections | immediately after surgery | Rate of R0-resections |
| Rate of compliance with radiotherapy and chemotherapy | 6-8 months | Rate of complications III-VI grade of radiotherapy (RTOG) and chemotherapy (NCI-CTC) |
| rate of intraoperative and postoperative complications | 0-30 days after surgery | Frequency and structure of intraoperative and postoperative complications according to the Clavien-Dindo classification |
Countries
Russia
Contacts
Primary ContactSergey Sychev, Dr.Med.Sc
Outcome results
None listed