A Phase II Study of Oxaliplatin Capecitabine and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

A Phase II Study of Oxaliplatin (Eloxatin) Capecitabine (Xeloda) and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220051
• Other study ID #: 1973
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2005
• Last updated: May 30, 2013
• Start date: November 2001

Study information

• Verified date: May 2013
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Oxaliplatin, Capecitabine

Procedure:
• Pre operative radiotherapy

• Surgical Resection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response rate.
Primary	Acute toxicity has been evaluated in previous phase I studies and should occur to a similar extent.
Secondary	Progression-free survival
Secondary	Treatment related toxicity
Secondary	Overall survival
Secondary	Radiological response rate
Secondary	Proportion of patients achieving pathological down staging compared with the pre-treatment MRI scan
Secondary	Surgical complications
Secondary	Bowel function and quality of life