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Neoadjuvant Chemotherapy in Patients With Moderate Risk Mid Rectal Cancer (RuCorT-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134897
Recruitment Status : Enrolling by invitation
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Sergey Gordeyev, Blokhin's Russian Cancer Research Center

Tracking Information
First Submitted Date  ICMJE October 19, 2019
First Posted Date  ICMJE October 22, 2019
Last Update Posted Date October 22, 2019
Actual Study Start Date  ICMJE October 14, 2019
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2019)
2-year local recurrence rate [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2019)
  • Adjuvant chemotherapy compliance [ Time Frame: 6 months ]
    Proportion of patients who receive a complete course of adjuvant chemotherapy
  • Acute chemotherapy toxicity [ Time Frame: 6 months ]
    Toxicity measured according to NCI-CTCAE v.5.0
  • pathologic complete response rate (pCR) [ Time Frame: 1 month ]
  • 2-year overall survival [ Time Frame: 2 years ]
  • 2-year disease-free survival [ Time Frame: 2 years ]
  • Operative morbidity [ Time Frame: 30 days ]
    Morbidity measured according to Clavien-Dindo classification
  • Neoadjuvant chemotherapy disease progression rate [ Time Frame: 3 months ]
    Proportion of patients with disease progression during neoadjuvant chemotherapy
  • Preoperative tumor-associated complications rate [ Time Frame: 3 months ]
    The rate of tumor-associated complications (bowel obastruction, bleeding etc) during neoadjuvant chemotherapy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Chemotherapy in Patients With Moderate Risk Mid Rectal Cancer
Official Title  ICMJE A Multicenter Prospective Phase III Clinical Trial of Neoadjuvant CapOx in Patients With Intermediate Risk CRM-negative Middle Rectal Cancer
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.
Detailed Description This trial aims to investigate the efficacy of neoadjuvant chemotherapy compared to 5x5 Gy neoadjuvant radiotherapy in moderate risk CRM-negative rectal cancer patients. This is a prospective multicenter open-label non-inferiority randomized phase III clinical trial. Patients will be randomized using an online randomization system to receive either 4 cycles of neoadjuvant CapOx (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 per os bid days 1-14) chemotherapy, surgery and 4 cycles of adjuvant CapOx chemotherapy or 5x5 Gy radiotherapy, surgery and 8 cycles of adjuvant CapOx chemotherapy. A stratification will be performed based on сN stage and clinical center. Patients with сT3c-T3dN0-1M0, cT1-T3dN2M0 cancer in the middle rectum are included. Chemoradiotherapy (50 Gy with concomitant capecitabine 825 mg/m2 per os bid on radiation days) will be performed for patients with tumor progression after neoadjuvant chemotherapy. The main hypothesis is that the 2-year local recurrence rate is non-inferior after neoadjuvant chemotherapy and neoadjuvant radiotherapy in moderate risk mid rectal cancer patients. The target accrual is 158 patients in each treatment arm (including 10% potential data loss) based on non-recurrence rate of 98% in investigated and 96% in the control group with a non-inferiority margin of 3%, α=0,05, power 80%. An interim analysis is planned after 50% of the patients will reach a 2-year followup. Pelvic Magnetic Resonance Imaging (MRI) is performed in all patients for staging before and after neoadjuvant chemotherapy and before surgery. Pelvic MRI is subject to central review. Conduction of this study and data collection are controlled by a local institutional board.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Rectal Neoplasms Malignant
  • Rectum Carcinoma
  • Rectal Cancer
Intervention  ICMJE
  • Drug: Capecitabine
    2000 mg/m2, bid, per os, days 1-14, 4 cycles
    Other Name: Xeloda
  • Drug: Oxaliplatin
    130 mg/m2 iv day 1, 4 cycles
  • Drug: Capecitabine
    825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
    Other Name: Xeloda
  • Radiation: Radiotherapy
    Pelvic radiotherapy dose: 44 Gy on regional nodes, 50 Gy on primary tumor
  • Procedure: Rectal cancer surgery
    Laparoscopic or open total mesorectal excision
  • Radiation: Radiotherapy
    Pelvic radiotherapy dose: 25 Gy in 5 Gy fractions
Study Arms  ICMJE
  • Experimental: Neoadjuvant chemotherapy
    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).
    Interventions:
    • Drug: Capecitabine
    • Drug: Oxaliplatin
    • Drug: Capecitabine
    • Radiation: Radiotherapy
    • Procedure: Rectal cancer surgery
  • Active Comparator: Neoadjuvant radiotherapy
    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).
    Interventions:
    • Drug: Capecitabine
    • Drug: Oxaliplatin
    • Procedure: Rectal cancer surgery
    • Radiation: Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 19, 2019)
316
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2024
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • inability of long-term followup of the patient
  • HIV
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04134897
Other Study ID Numbers  ICMJE RuCorT-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sergey Gordeyev, Blokhin's Russian Cancer Research Center
Study Sponsor  ICMJE Blokhin's Russian Cancer Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zaman Z Mamedli, PhD N.N.Blokhin Russian Cancer Research Center
PRS Account Blokhin's Russian Cancer Research Center
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP