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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

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: Folfox Protocol Drug: Capox Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
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
Official Title: NEO: Neoadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer
Actual Study Start Date : August 22, 2017
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2022

Arm Intervention/treatment
Experimental: chemotherapy (FOLFOX or CAPOX) followed by tumour excision Drug: Folfox Protocol
6 cycles of q2weekly FOLFOX, or

Drug: Capox
4 cycles of q3weekly CAPOX




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Locoregional Relapse Rate (LRR) [ Time Frame: 3 years ]
  2. Distant Relapse Rate (DRR) estimated based on Kaplan-Meier method [ Time Frame: 3 years ]
  3. Disease Free Survival (DFS) estimated based on Kaplan-Meier method [ Time Frame: 3 years ]
  4. Rate of post-operative complications [ Time Frame: 3 years ]
  5. Number and severity of adverse events using CTCAE V5 [ Time Frame: 3 years ]
  6. Quality of Life using QLQ-C30 [ Time Frame: 3 years ]
  7. Cost effectiveness using the EQ-5D-5L questionnaire [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.

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): NCT03259035


Locations
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United States, California
UC Irvine Medical Center
Orange, California, United States, 92868
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 97101
Canada, British Columbia
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Health Sciences North
Sudbury, Ontario, Canada, P3E 5J1
Canada, Quebec
The Research Institute of the McGill University
Montreal, Quebec, Canada, H4A 3J1
Sponsors and Collaborators
Canadian Cancer Trials Group
Investigators
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Study Chair: Hagen Kennecke Virginia Mason Medical Centre, WA USA
Study Chair: Carl Brown St. Paul's Hospital, Vancouver BC
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Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT03259035    
Other Study ID Numbers: CO28
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases