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This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| total neoadjuvant therapy | Experimental | Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary. |
|
| standard therapy | Active Comparator | Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concurrent Chemoradiotherapy | Combination Product | 50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of complete responses | The rate of pathological or clinical complete responses | 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of R0-resections | Rate of R0-resections | immediately after surgery |
| Rate of compliance with radiotherapy and chemotherapy | Rate of complications III-VI grade of radiotherapy (RTOG) and chemotherapy (NCI-CTC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergey Sychev, Dr.Med.Sc | Contact | +7 9097845436 | dr.sychev.si@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Evgeny Rybakov, Dr.Med.Sc | Head of Surgical department of oncoproctology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Scientific Centre of Coloproctology | Recruiting | Moscow | 123453 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22362002 | Background | Martin ST, Heneghan HM, Winter DC. Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancer. Br J Surg. 2012 Jul;99(7):918-28. doi: 10.1002/bjs.8702. Epub 2012 Feb 23. | |
| 22434243 | Background | Zorcolo L, Rosman AS, Restivo A, Pisano M, Nigri GR, Fancellu A, Melis M. Complete pathologic response after combined modality treatment for rectal cancer and long-term survival: a meta-analysis. Ann Surg Oncol. 2012 Sep;19(9):2822-32. doi: 10.1245/s10434-011-2209-y. Epub 2012 Mar 21. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| D011878 | Radiotherapy |
| D060830 | Consolidation Chemotherapy |
| C519688 | XELOX |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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Parallel Assignment
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|
| TME | Procedure | Total mesorectal excision |
|
| consolidation chemotherapy | Drug | 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 |
|
|
| adjuvant chemotherapy | Drug | 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 |
|
|
| 6-8 months |
| rate of intraoperative and postoperative complications | Frequency and structure of intraoperative and postoperative complications according to the Clavien-Dindo classification | 0-30 days after surgery |
| 16246976 | Background | Rodel C, Martus P, Papadoupolos T, Fuzesi L, Klimpfinger M, Fietkau R, Liersch T, Hohenberger W, Raab R, Sauer R, Wittekind C. Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer. J Clin Oncol. 2005 Dec 1;23(34):8688-96. doi: 10.1200/JCO.2005.02.1329. Epub 2005 Oct 24. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |