Total Neoadjuvant Therapy in Rectal Cancer Treatment
Overview
- Phase
- Phase 4
- Intervention
- Concurrent Chemoradiotherapy
- Conditions
- Rectal Cancer
- Sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- The rate of complete responses
- Last Updated
- 5 years ago
Overview
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.
Investigators
Rybakov Evgeny, MD
Head of Surgical department of oncoproctology
State Scientific Centre of Coloproctology, Russian Federation
Eligibility Criteria
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
Arms & Interventions
total neoadjuvant therapy
Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.
Intervention: Concurrent Chemoradiotherapy
total neoadjuvant therapy
Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.
Intervention: TME
total neoadjuvant therapy
Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.
Intervention: consolidation chemotherapy
total neoadjuvant therapy
Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.
Intervention: adjuvant chemotherapy
standard therapy
Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
Intervention: Concurrent Chemoradiotherapy
standard therapy
Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
Intervention: TME
standard therapy
Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
Intervention: adjuvant chemotherapy
Outcomes
Primary Outcomes
The rate of complete responses
Time Frame: 3-6 months
The rate of pathological or clinical complete responses
Secondary Outcomes
- Rate of R0-resections(immediately after surgery)
- Rate of compliance with radiotherapy and chemotherapy(6-8 months)
- rate of intraoperative and postoperative complications(0-30 days after surgery)