Total Neoadjuvant Therapy in Rectal Cancer Treatment

February 10, 2021 updated by: Rybakov Evgeny, MD, State Scientific Centre of Coloproctology, Russian Federation
This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 123453
        • Recruiting
        • State Scientific Centre of Coloproctology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: TME
Total mesorectal excision
Combination product: Concurrent 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

Other Names:
  • Radiotherapy
Drug: consolidation chemotherapy
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
Other Names:
  • XELOX
  • CAPOX
Drug: adjuvant 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
Other Names:
  • mFOLFOX
Active Comparator: standard therapy
Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)
Procedure: TME
Total mesorectal excision
Combination product: Concurrent 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

Other Names:
  • Radiotherapy
Drug: adjuvant 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
Other Names:
  • mFOLFOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of complete responses
Time Frame: 3-6 months
The rate of pathological or clinical complete responses
3-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of R0-resections
Time Frame: immediately after surgery
Rate of R0-resections
immediately after surgery
Rate of compliance with radiotherapy and chemotherapy
Time Frame: 6-8 months
Rate of complications III-VI grade of radiotherapy (RTOG) and chemotherapy (NCI-CTC)
6-8 months
rate of intraoperative and postoperative complications
Time Frame: 0-30 days after surgery
Frequency and structure of intraoperative and postoperative complications according to the Clavien-Dindo classification
0-30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State Scientific Centre of Coloproctology, Russian Federation

Investigators

  • Principal Investigator: Evgeny Rybakov, Dr.Med.Sc, Head of Surgical department of oncoproctology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2020

Primary Completion (Anticipated)

October 30, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 127872

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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