Total Neoadjuvant Therapy in Rectal Cancer Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-30

Study Completion Date

2023-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Total Neoadjuvant Therapy Versus Standard Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer

NCT05274945

Rectal Cancer

COMPLETED PHASE2

Total Neoadjuvant Treatment vs. Chemoradiotherapy in Local Advanced Rectal Cancer With High Risk Factors

NCT03177382

Total Neoadjuvant Treatment Chemoradiotherapy Local Advanced Rectal Cancer +1 more

UNKNOWN PHASE3

Neoadjuvant Chemoradiotherapy Versus Total Neoadjuvant Therapy in the Treatment of T3 Rectal Cancer

NCT06097416

Rectal Cancer

NOT_YET_RECRUITING PHASE3

Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial

NCT05496491

Rectal Neoplasms

RECRUITING NA

Neoadjuvant Radiotherapy Followed by Transanal Endoscopic Microsurgery for T1-T2 Extraperitoneal Rectal Cancer

NCT02127645

RECTAL CANCER

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Concurrent Chemoradiotherapy

Intervention Type 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

TME

Intervention Type PROCEDURE

Total mesorectal excision

consolidation chemotherapy

Intervention Type 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

Intervention Type 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

standard therapy

Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy)

Group Type ACTIVE_COMPARATOR

Concurrent Chemoradiotherapy

Intervention Type 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

TME

Intervention Type PROCEDURE

Total mesorectal excision

adjuvant chemotherapy

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type COMBINATION_PRODUCT

TME

Total mesorectal excision

Intervention Type PROCEDURE

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Radiotherapy XELOX CAPOX mFOLFOX

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No