Clinical trial NCT01941641: Colon Neoadjuvant FOLFOXIRI Study
Official title: A Phase II Study of Neoadjuvant FOLFOXIRI Followed by Concurrent Capecitabine and Radiotherapy for High Risk Rectal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Rectal Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Objective tumour response rate
timeFrame: 2 years
Secondary outcomes:
measure: Tumour regression grade
timeFrame: 2 years
measure: pathologic complete response
timeFrame: 2 years
measure: Rate of circumferential resection margin (CRM) clearance
timeFrame: 2 years
measure: Rate of tumour downstaging
timeFrame: 2 years
measure: Number of Participants with Adverse Events
timeFrame: 2 years
measure: Overall survival
timeFrame: 5 years
measure: disease-free survival, relapse-free survival
timeFrame: 5 years
measure: Time to local (and distant) recurrence
timeFrame: 5 years
measure: Number of patients with 30-day post-operative mortality
timeFrame: 1 month
measure: Compliance to study treatment
timeFrame: 2 years
measure: Number of response to neoadjuvant therapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology
Study officials:
affiliation: Chinese University of Hong Kong
name: Brigette MA, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: