Induction and Consolidation Chemotherapy in Patients With Locally Advanced CRM-positive Rectal Cancer

NCT04135313 | Unknown Phase 3

• 1 other identifier: RuCorT-03
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the addition of 2 cycles of induction CapOx chemotherapy and 2 cycles of consolidation CapOx chemotherapy to standard chemoradiation improves 3-year disease-free survival in patients with locally advanced CRM"+" mid and low rectal cancer.

Conditions

Rectal Neoplasms Malignant; Rectum Carcinoma; Rectal Cancer

Keywords

rectal cancer; induction chemotherapy; consolidation chemotherapy; neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival

  3 years

Secondary Outcomes (8)

• Adjuvant chemotherapy compliance

  6 months

• Acute chemotherapy toxicity

  6 months

• pathologic complete response rate (pCR)

  1 month

• local recurrence rate

  3 years

• 3-year overall survival

  3 years

Study Arms (2)

Neoadjuvant chemotherapy

EXPERIMENTAL

Patients receive 2 cycles of induction CapOx (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 per os bid days 1-14) chemotherapy, followed by chemoradiotherapy (54 Gy in 2 Gy fractions with concomitant capecitabine 825 mg/m2 per os bid on radiation days), then 2 cycles of consolidation CapOx chemotherapy, surgery (10-12 weeks following chemoradiotherapy) and 2 cycles of adjuvant CapOx chemotherapy

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

Chemoradiotherpy

ACTIVE COMPARATOR

Patients receive 54 Gy pelvic chemoradiotherapy in 2 Gy fractions with capecitabine 825 mg/m2 bid per os on radiation days and then surgery following 10-12 weeks. After surgery patients receive 6 cycles of adjuvant CapOx chemotherapy.

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

Interventions

Capecitabine DRUG

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

Also known as: Xeloda

Chemoradiotherpy; Neoadjuvant chemotherapy

Oxaliplatin DRUG

130 mg/m2 iv day 1

Chemoradiotherpy; Neoadjuvant chemotherapy

Radiotherapy RADIATION

Pelvic radiotherapy dose: 44 Gy on regional nodes, 54 Gy on primary tumor in 2 Gy fractions

Chemoradiotherpy; Neoadjuvant chemotherapy

Rectal cancer surgery PROCEDURE

Laparoscopic or open total mesorectal excision or extralevator abdominoperineal resection

Chemoradiotherpy; Neoadjuvant chemotherapy

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 0-10 cm above the anal verge
• No distant metastases
• Circumferential resection margin (CRM) involvement (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
• cT2N0M0 rectal cancer
• 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

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 20, 2019
• First Posted: October 22, 2019
• Study Start: October 20, 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)