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NEO: Neoadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer

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: NCT03259035
Recruitment Status : Active, not recruiting
First Posted : August 23, 2017
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Tracking Information
First Submitted Date  ICMJE August 21, 2017
First Posted Date  ICMJE August 23, 2017
Last Update Posted Date November 10, 2020
Actual Study Start Date  ICMJE August 22, 2017
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2017)
Measurement of organ preservation rate [ Time Frame: 3 years ]
The primary endpoint of this study is the protocol specified organ preservation rate, defined as the proportion of patients with tumour downstaging to ypT0/T1good N0 and who avoid radical surgery. The 95% confidence interval for the organ preservation rate will be calculated
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2018)
  • Locoregional Relapse Rate (LRR) [ Time Frame: 3 years ]
  • Distant Relapse Rate (DRR) estimated based on Kaplan-Meier method [ Time Frame: 3 years ]
  • Disease Free Survival (DFS) estimated based on Kaplan-Meier method [ Time Frame: 3 years ]
  • Rate of post-operative complications [ Time Frame: 3 years ]
  • Number and severity of adverse events using CTCAE V5 [ Time Frame: 3 years ]
  • Quality of Life using QLQ-C30 [ Time Frame: 3 years ]
  • Cost effectiveness using the EQ-5D-5L questionnaire [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2017)
  • Locoregional Relapse Rate (LRR) [ Time Frame: 3 years ]
  • Distant Relapse Rate (DRR) estimated based on Kaplan-Meier method [ Time Frame: 3 years ]
  • Disease Free Survival (DFS) estimated based on Kaplan-Meier method [ Time Frame: 3 years ]
  • Rate of post-operative complications [ Time Frame: 3 years ]
  • Number and severity of adverse events using CTCAE V4 [ Time Frame: 3 years ]
  • Quality of Life using QLQ-C30 [ Time Frame: 3 years ]
  • Cost effectiveness using the EQ-5D-5L questionnaire [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NEO: Neoadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer
Official Title  ICMJE NEO: Neoadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer
Brief Summary The purpose of this study is to find out the effects of chemotherapy followed by less invasive surgery on patients and their early rectal cancer. The approach of this trial will be considered a success if at least 65% of participants are able to keep the rectum.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This is a two staged, single arm phase II trial of chemotherapy (FOLFOX or CAPOX) followed by tumour excision in patients with early stage rectal cancer
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectal Cancer
Intervention  ICMJE
  • Drug: Folfox Protocol
    6 cycles of q2weekly FOLFOX, or
  • Drug: Capox
    4 cycles of q3weekly CAPOX
Study Arms  ICMJE Experimental: chemotherapy (FOLFOX or CAPOX) followed by tumour excision
Interventions:
  • Drug: Folfox Protocol
  • Drug: Capox
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 21, 2017)
58
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed invasive well-moderately differentiated rectal adenocarcinoma diagnosed within 90 days prior to enrollment.
  • Tumour stage cT1-T3abN0 based on pelvic MRI

    • cT1N0- tumour invasion into submucosa, no radiographic evidence of mesorectal nodal metastasis, tumour deposits or vascular invasion.
    • cT2N0 - tumour invasion into muscularis propria, no radiographic evidence of mesorectal nodal metastasis, tumour deposits or vascular invasion.
    • cT3a,bN0- tumour invasion through the muscularis propria no more than 5 mm into the subserosa/perirectal tissue and clear of the circumferential radial margin (CRM). Absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or lymphovascular invasion.

Note: If the tumour is not visualized in the MRI but there is histological confirmation of rectal adenocarcinoma the patient is eligible.

  • cN0 stage based on pelvic MRI. Any nodes ≥ 10 mm in longest dimension are considered malignant, regardless of nodal morphology. For pelvic nodes < 10 mm in longest dimension, if nodes are seen and are deemed to be morphologically benign in the opinion of the radiologist and surgeon, the patient is eligible. Patients with visible pelvic sidewall nodes are excluded
  • M0 stage based on no evidence of metastatic disease by CT imaging.
  • Mid to low-lying tumour eligible for local tumour excision in the opinion of the treating surgeon.
  • Age of at least 18 years.
  • Medically fit to undergo radical surgery as per treating surgeon's discretion
  • No contraindications to protocol chemotherapy.
  • Adequate normal organ and marrow function as defined below (must be done within 30 days prior to enrolment):

    • ANC ≥ 1.5 x 109/L
    • platelet count ≥100 x 109/L
    • bilirubin < 1.5 ULN, excluding Gilbert's syndrome
    • Calculated creatinine clearance of ≥ 50 ml/min.
    • Clearance to be calculated using Cockcroft formula: Males: 1.23 x (140 - age) x weight (kg) - serum creatinine (μmol/l) ; Females: 1.05 x (140 - age) x weight (kg) - serum creatinine (μmol/l)
  • The patient must have an ECOG performance status of 0, 1.
  • Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and health utility questionnaires.
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
  • Must be accessible for treatment and follow up. Patients registered on this trial must be treated with chemotherapy and followed at the enrolling centre.
  • Protocol treatment is to begin within 5 working days of patient enrollment.
  • Women/men of childbearing potential must have agreed to use a highly effective contraceptive method during and for 6 months after completion of chemotherapy.

Exclusion Criteria:

  • Patient has pathologic high risk factors on either the initial biopsy specimen report or follow-up biopsy (if done): high histologic grade, mucinous histology, lymphatic or vascular invasion.
  • History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
  • Synchronous cancer.
  • Prior treatment for rectal cancer.
  • Previous pelvic radiation for any reason.
  • Patients with known dihydropyrimidine dehydrogenase deficiency
  • Treatment with other investigational drugs or anti-cancer therapy within 28 days prior to enrolment.
  • Clinically significant (i.e. active) cardiovascular disease for example cerebro vascular accidents (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina, New York Heart Association (NYHA) grade II or higher, congestive heart failure, serious cardiac arrhythmia requiring medication.
  • Any contra-indications to undergo MRI imaging.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03259035
Other Study ID Numbers  ICMJE CO28
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Canadian Cancer Trials Group
Study Sponsor  ICMJE Canadian Cancer Trials Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hagen Kennecke Virginia Mason Medical Centre, WA USA
Study Chair: Carl Brown St. Paul's Hospital, Vancouver BC
PRS Account Canadian Cancer Trials Group
Verification Date May 2020

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