Neoadjuvant Chemotherapy in Patients With Moderate Risk Mid Rectal Cancer

NCT04134897 | Unknown Phase 3

• 1 other identifier: RuCorT-02
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether 3 months of neoadjuvant CapOx is non-inferior to neoadjuvant radiotherapy in patients with moderate risk CRM"-" mid rectal cancer.

Conditions

Rectal Neoplasms Malignant; Rectum Carcinoma; Rectal Cancer

Keywords

rectal cancer; neoadjuvant chemotherapy; neoadjuvant radiotherapy

Outcome Measures

Primary Outcomes (1)

• 2-year local recurrence rate

  2 years

Secondary Outcomes (8)

• Adjuvant chemotherapy compliance

  6 months

• Acute chemotherapy toxicity

  6 months

• pathologic complete response rate (pCR)

  1 month

• 2-year overall survival

  2 years

• 2-year disease-free survival

  2 years

Study Arms (2)

Neoadjuvant chemotherapy

EXPERIMENTAL

Patients will receive 4 cycles of neoadjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks). In case of partial response or stable disease (based on pelvic MRI) patients proceed to surgery within 2 weeks. In case of disease progression patients receive 50 Gy pelvic chemoradiotherapy with capecitabine 825 mg/m2 bid per os on radiation days and then surgery following 8-10 weeks. After surgery patients receive 4 cycles of adjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks).

Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiotherapy; Procedure: Rectal cancer surgery

Neoadjuvant radiotherapy

ACTIVE COMPARATOR

Patients will receive 5x5 Gy radiotherapy and then surgery following 6-8 weeks. After surgery patients receive 8 cycles of adjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks).

Drug: Capecitabine; Drug: Oxaliplatin; Procedure: Rectal cancer surgery; Radiation: Radiotherapy

Interventions

Capecitabine DRUG

2000 mg/m2, bid, per os, days 1-14, 4 cycles

Also known as: Xeloda

Neoadjuvant chemotherapy; Neoadjuvant radiotherapy

Oxaliplatin DRUG

130 mg/m2 iv day 1, 4 cycles

Neoadjuvant chemotherapy; Neoadjuvant radiotherapy

Radiotherapy RADIATION

Pelvic radiotherapy dose: 44 Gy on regional nodes, 50 Gy on primary tumor

Neoadjuvant chemotherapy

Rectal cancer surgery PROCEDURE

Laparoscopic or open total mesorectal excision

Neoadjuvant chemotherapy; Neoadjuvant radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Histologically verified colon rectal adenocarcinoma
• сT3c-T3dN0-1M0, cT1-T3dN2M0. cancer of the middle rectum (based on pelvic MRI)
• Tumor more than 2 mm from mesorectal fascia (based on pelvic MRI)
• Eastern Cooperative Oncology Group (ECOG) status 0-2
• Haemoglobin (HGB) \> 90 g/L
• Platelet Count (PLT) \> 120x10\*9/L
• Serum creatinine \< 150 µmol/L
• Total bilirubin \< 25 µmol/L

You may not qualify if:

• inability to obtain informed consent
• distant metastases
• synchronous or metachronous tumors
• previous chemotherapy or radiotherapy
• clinically significant cardiovascular disorders (myocardial infarction \< 6 months before visit, stroke \< \< 6 months before visit, instable angina \< 3 months before visit, arrhythmia, uncontrolled hypertension \> 160/100 mm hg
• clinically significant neurological disorders
• previous neuropathy 2 or higher
• current infection or heavy systemic disease
• pregnancy, breastfeeding
• ulcerative colitis
• individual intolerance to treatment components
• proven dihydropyrimidine dehydrogenase (DPD) deficiency
• participation in other clinical trials
• psychiatric disorders, which render patient unable to follow instructions or understand his/her condition
• technical inability to perform pelvic MRI

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead

Study Sites (1)

N.N.Blokhin Russian Cancer Research Center

Moscow, 115478, Russia

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine; Oxaliplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Therapeutics

Study Officials

• Zaman Z Mamedli, PhD

  N.N.Blokhin Russian Cancer Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Consultant surgeon

Study Record Dates

• First Submitted: October 19, 2019
• First Posted: October 22, 2019
• Study Start: October 14, 2019
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)