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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

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.

Condition or disease Intervention/treatment Phase
Rectal Neoplasms Malignant Rectum Carcinoma Rectal Cancer Drug: Capecitabine Drug: Oxaliplatin Radiation: Radiotherapy Procedure: Rectal cancer surgery Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Prospective Phase III Clinical Trial of Neoadjuvant CapOx in Patients With Intermediate Risk CRM-negative Middle Rectal Cancer
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Arm Intervention/treatment
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).
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

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).
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

Procedure: Rectal cancer surgery
Laparoscopic or open total mesorectal excision

Radiation: Radiotherapy
Pelvic radiotherapy dose: 25 Gy in 5 Gy fractions




Primary Outcome Measures :
  1. 2-year local recurrence rate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Adjuvant chemotherapy compliance [ Time Frame: 6 months ]
    Proportion of patients who receive a complete course of adjuvant chemotherapy

  2. Acute chemotherapy toxicity [ Time Frame: 6 months ]
    Toxicity measured according to NCI-CTCAE v.5.0

  3. pathologic complete response rate (pCR) [ Time Frame: 1 month ]
  4. 2-year overall survival [ Time Frame: 2 years ]
  5. 2-year disease-free survival [ Time Frame: 2 years ]
  6. Operative morbidity [ Time Frame: 30 days ]
    Morbidity measured according to Clavien-Dindo classification

  7. Neoadjuvant chemotherapy disease progression rate [ Time Frame: 3 months ]
    Proportion of patients with disease progression during neoadjuvant chemotherapy

  8. Preoperative tumor-associated complications rate [ Time Frame: 3 months ]
    The rate of tumor-associated complications (bowel obastruction, bleeding etc) during neoadjuvant chemotherapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134897


Locations
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Russian Federation
N.N.Blokhin Russian Cancer Research Center
Moscow, Russian Federation, 115478
Sponsors and Collaborators
Blokhin's Russian Cancer Research Center
Investigators
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Principal Investigator: Zaman Z Mamedli, PhD N.N.Blokhin Russian Cancer Research Center

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Responsible Party: Sergey Gordeyev, Principal Investigator, Consultant surgeon, Blokhin's Russian Cancer Research Center
ClinicalTrials.gov Identifier: NCT04134897    
Other Study ID Numbers: RuCorT-02
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sergey Gordeyev, Blokhin's Russian Cancer Research Center:
rectal cancer
neoadjuvant chemotherapy
neoadjuvant radiotherapy
Additional relevant MeSH terms:
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Rectal Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents