Colon Neoadjuvant FOLFOXIRI Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01941641
Recruitment Status : Recruiting
First Posted : September 13, 2013
Last Update Posted : September 21, 2018
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong

Brief Summary:
Objective tumour response rate to FOLFOXIRI to pre-operative therapy.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: neoadjuvant FOLFOXIRI Drug: Capecitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Neoadjuvant FOLFOXIRI Followed by Concurrent Capecitabine and Radiotherapy for High Risk Rectal Cancer
Actual Study Start Date : October 9, 2013
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: neoadjuvant FOLFOXIRI Drug: neoadjuvant FOLFOXIRI
Drug: Capecitabine

Primary Outcome Measures :
  1. Objective tumour response rate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Tumour regression grade [ Time Frame: 2 years ]
  2. pathologic complete response [ Time Frame: 2 years ]
  3. Rate of circumferential resection margin (CRM) clearance [ Time Frame: 2 years ]
  4. Rate of tumour downstaging [ Time Frame: 2 years ]
  5. Number of Participants with Adverse Events [ Time Frame: 2 years ]
  6. Overall survival [ Time Frame: 5 years ]
  7. disease-free survival, relapse-free survival [ Time Frame: 5 years ]
  8. Time to local (and distant) recurrence [ Time Frame: 5 years ]
  9. Number of patients with 30-day post-operative mortality [ Time Frame: 1 month ]
  10. Compliance to study treatment [ Time Frame: 2 years ]
  11. Number of response to neoadjuvant therapy [ Time Frame: 2 years ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age >= 18 years of either sex.
  • ECOG performance status 0-1
  • Measurable disease by RECIST 1.1 criteria.
  • Histologically confirmed rectal adenocarcinoma (defined as either mid- or low rectal cancer that is located within 12 cm from the anal verge OR below the peritoneal reflection) that is previously untreated.
  • 'High risk' rectal cancer, or rectal cancers that are considered marginally operable where there is a significant risk of positive surgical margin:

    • T3 (low-lying tumour at or below the levators) or T4, or
    • Tumour infiltrating perirectal fat, or
    • Any T-stage (T1-4) and node-positive tumour (invading surrounding structures or peritoneum)
  • Adequate bone marrow, renal and hepatic function as defined by: absolute neutrophil count >= 1.5 x 109/L, hemoglobin >= 9 g/L, platelets >= 100 x 109/L, calculated creatinine clearance >= 55 ml/min, total bilirubin =<1.5 x the upper limit of normal, alanine aminotransferase (ALT) =<2.5 upper limit of normal.

Exclusion Criteria:

  • Known distant metastasis, even if the metastasis has been resected.
  • History of another invasive malignancy within the last 5 years, except for treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia, or non-invasive DCIS of the breast.
  • Upper rectal cancer that is located above the peritoneal reflection.
  • Primary tumour associated with any one of the following features:

    • Frank intestinal obstruction, or
    • Endoscope unable to pass through the tumour's lumen plus worsening local obstructive symptoms. Note: Patients with such features should be assessed by the surgical team regarding stomal bypass prior to study enrolment. Such patients can still be considered for study enrolment after undergoing stomal bypass.
  • Known hypersensitivity reaction to the study drugs (i.e. fluoropyrimidine, irinotecan, oxaliplatin)
  • Known peripheral neuropathy of grade 2 or more in severity.
  • Patients who have received an experimental anticancer therapy within the last 28 days.
  • Previous pelvic radiotherapy. Previous oxaliplatin or irinotecan for the treatment of colon or rectal cancer
  • Patient with hip prosthesis
  • Major surgery within the last 28 days. Exception: Any patient who underwent stomal bypass for obstructing primary tumour within the last 14 days are still eligible, as long as the patient has sufficiently recovered from the surgery at the investigator's discretion.

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 identifier (NCT number): NCT01941641

Contact: Brigette MA, MD, FRCP 3505 2118
Contact: Jane Koh, RN 3505 1142

Hong Kong
Department of Clinical Oncology Recruiting
Hong Kong, Hong Kong
Contact: Brigette MA, MD, FRCP    3505 2118   
Contact: Jane KOH, RN    3505 1142   
Principal Investigator: Brigette MA, MD,FRCP         
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Brigette MA, MD, FRCP Chinese University of Hong Kong

Responsible Party: CCTU, Comprehensive Cancer Trials Unit, Chinese University of Hong Kong Identifier: NCT01941641     History of Changes
Other Study ID Numbers: COL021
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents