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Total Neoadjuvant Therapy in Rectal Cancer Treatment

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Concurrent Chemoradiotherapy
TME
consolidation chemotherapy
adjuvant chemotherapy
Sponsored by
State Scientific Centre of Coloproctology, Russian Federation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, total neoadjuvant therapy, colorectal disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • State Scientific Centre of ColoproctologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

total neoadjuvant therapy

standard therapy

Arm Description

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 (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)

Outcomes

Primary Outcome Measures

The rate of complete responses
The rate of pathological or clinical complete responses

Secondary Outcome Measures

Rate of R0-resections
Rate of R0-resections
Rate of compliance with radiotherapy and chemotherapy
Rate of complications III-VI grade of radiotherapy (RTOG) and chemotherapy (NCI-CTC)
rate of intraoperative and postoperative complications
Frequency and structure of intraoperative and postoperative complications according to the Clavien-Dindo classification

Full Information

First Posted
February 5, 2021
Last Updated
February 10, 2021
Sponsor
State Scientific Centre of Coloproctology, Russian Federation
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1. Study Identification

Unique Protocol Identification Number
NCT04747951
Brief Title
Total Neoadjuvant Therapy in Rectal Cancer Treatment
Official Title
Total Neoadjuvant Therapy in Rectal Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State Scientific Centre of Coloproctology, Russian Federation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
rectal cancer, total neoadjuvant therapy, colorectal disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
total neoadjuvant therapy
Arm Type
Experimental
Arm Description
Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary.
Arm Title
standard therapy
Arm Type
Active Comparator
Arm Description
Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
Intervention Type
Combination Product
Intervention Name(s)
Concurrent Chemoradiotherapy
Other Intervention Name(s)
Radiotherapy
Intervention Description
50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d
Intervention Type
Procedure
Intervention Name(s)
TME
Intervention Description
Total mesorectal excision
Intervention Type
Drug
Intervention Name(s)
consolidation chemotherapy
Other Intervention Name(s)
XELOX, CAPOX
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
adjuvant chemotherapy
Other Intervention Name(s)
mFOLFOX
Intervention Description
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
Primary Outcome Measure Information:
Title
The rate of complete responses
Description
The rate of pathological or clinical complete responses
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
Rate of R0-resections
Description
Rate of R0-resections
Time Frame
immediately after surgery
Title
Rate of compliance with radiotherapy and chemotherapy
Description
Rate of complications III-VI grade of radiotherapy (RTOG) and chemotherapy (NCI-CTC)
Time Frame
6-8 months
Title
rate of intraoperative and postoperative complications
Description
Frequency and structure of intraoperative and postoperative complications according to the Clavien-Dindo classification
Time Frame
0-30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergey Sychev, Dr.Med.Sc
Phone
+7 9097845436
Email
dr.sychev.si@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny Rybakov, Dr.Med.Sc
Organizational Affiliation
Head of Surgical department of oncoproctology
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Scientific Centre of Coloproctology
City
Moscow
ZIP/Postal Code
123453
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Sychev
Phone
+79097845436
Ext
+79097845436
Email
dr.sychev.si@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22362002
Citation
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.
Results Reference
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PubMed Identifier
22434243
Citation
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.
Results Reference
background
PubMed Identifier
16246976
Citation
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.
Results Reference
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Total Neoadjuvant Therapy in Rectal Cancer Treatment

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