Clinical trial NCT00220051: A Phase II Study of Oxaliplatin Capecitabine and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer
Official title: A Phase II Study of Oxaliplatin (Eloxatin) Capecitabine (Xeloda) and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of pre-operative capecitabine and oxaliplatin followed by capecitabine with concurrent radiotherapy followed by post-operative capecitabine in the treatment of patients with locally advanced or inoperable rectal cancer.


Eligibility criteria: Inclusion Criteria:

* Age over 18.
* Histological diagnosis of adenocarcinoma of rectum.
* Locally advanced/ poor prognosis primary rectal cancer defined by MRI criteria of any of the categories below;

  * Tumour within 2 mm of mesorectal fascia ie circumferential resection margin threatened
  * Any T3 tumour at/below levatores
  * T3c tumour at any other level ie tumour extends \>5 mm into peri-rectal fat
  * T4 tumour
  * Any T stage with 4 or more involved lymph nodes
* WHO performance status 0, 1 or 2.
* No evidence of metastatic disease as determined by CT scan of chest, abdomen, pelvis or other investigations such as PET scan or biopsy if required.
* Adequate bone marrow function with platelets \> 100 X 109/l; WBC \> 3 X 109/l; neutrophils \> 1.5 X 109/l
* Normal renal function, with serum creatinine within the normal range or calculated creatinine clearance \>50 ml/min.
* Adequate hepatic function with serum total bilirubin \< 1.5 X upper limit of normal range.
* No concurrent uncontrolled medical conditions
* No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix
* Adequate contraceptive precautions if relevant
* Informed written consent

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent
* Presence of metastatic disease or recurrent rectal tumour
* Renal impairment (creatinine clearance\<30 ml/min)
* Pregnancy or breast feeding
* Patients with a lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes
* Participation in any investigational drug study within the previous 4 weeks.
* Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the last 12 months)
* Patients with any symptoms or history of peripheral neuropathy.
* Prior pelvic radiotherapy

Primary outcomes:
measure: Pathological complete response rate.
measure: Acute toxicity has been evaluated in previous phase I studies and should occur to a similar extent.
Secondary outcomes:
measure: Progression-free survival
measure: Treatment related toxicity
measure: Overall survival
measure: Radiological response rate
measure: Proportion of patients achieving pathological down staging compared with the pre-treatment MRI scan
measure: Surgical complications
measure: Bowel function and quality of life
Other outcomes:
Locations:
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: D Cunningham
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chua YJ, Barbachano Y, Cunningham D, Oates JR, Brown G, Wotherspoon A, Tait D, Massey A, Tebbutt NC, Chau I. Neoadjuvant capecitabine and oxaliplatin before chemoradiotherapy and total mesorectal excision in MRI-defined poor-risk rectal cancer: a phase 2 trial. Lancet Oncol. 2010 Mar;11(3):241-8. doi: 10.1016/S1470-2045(09)70381-X. Epub 2010 Jan 25.