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Total Neoadjuvant Therapy in Rectal Cancer Treatment

NCT04747951 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2021-02-15

No results posted yet for this study

Summary

This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.

Conditions

Interventions

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

PROCEDURE

TME

Total mesorectal excision

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

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

Sponsors & Collaborators

  • State Scientific Centre of Coloproctology, Russian Federation

    lead OTHER_GOV

Principal Investigators

  • Evgeny Rybakov, Dr.Med.Sc · Head of Surgical department of oncoproctology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-30
Primary Completion
2023-10-30
Completion
2023-11-01
FDA Drug
Yes

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04747951 on ClinicalTrials.gov