Neoadjuvant Chemotherapy in Patients With Intermediate Risk Upper and Mid Rectal Cancer

NCT04103697 | Unknown Phase 3

• 1 other identifier: RuCorT-01
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether 4 cycles of neoadjuvant CapOx chemotherapy is more effective than the upfront surgery in patients with intermediate risk CRM"-" mid and upper rectal cancer.

Conditions

Rectal Neoplasms Malignant; Rectum Carcinoma; Rectal Cancer

Keywords

rectal cancer; neoadjuvant chemotherapy; mesorectal excision

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival

  3 years

Secondary Outcomes (8)

• Adjuvant chemotherapy compliance

  6 months

• Acute chemotherapy toxicity

  14 weeks

• pathologic complete response rate (pCR)

  1 month

• local recurrence rate

  3 years

• 3-year overall survival

  3 years

Study Arms (2)

4xCapOx

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. 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. The decision to proceed with adjuvant chemotherapy postoperatively will be based on pTNM stage

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

Surgery

ACTIVE COMPARATOR

Patients will receive standard surgery for rectal cancer with partial or total mesorectal excision (based on exact tumor location and surgeons discretion). The decision to proceed with adjuvant chemotherapy postoperatively will be based on pTNM stage

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

Interventions

Capecitabine DRUG

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

Also known as: Xeloda

4xCapOx; Surgery

Oxaliplatin DRUG

130 mg/m2 iv day 1, 4 cycles

4xCapOx; Surgery

Radiotherapy RADIATION

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

4xCapOx

Rectal cancer surgery PROCEDURE

Laparoscopic or open partial or total mesorectal excision (based on exact tumor location and surgeons discretion)

4xCapOx; Surgery

Eligibility Criteria

• Age: 18 Years - 70 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
• cT3-4aN1-2M0 cancer of the upper rectum or сТ2-Т3bN1M0 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: September 24, 2019
• First Posted: September 25, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

RU (1)