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

NCT ID: NCT00220051

Last Updated: 2013-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Oxaliplatin, Capecitabine

Intervention Type: DRUG

Pre operative radiotherapy

Intervention Type: PROCEDURE

Surgical Resection

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

D Cunningham

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

References

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.

Reference Type: DERIVED

PMID: 20106720 (View on PubMed)

Other Identifiers

1973

Identifier Type: -

Identifier Source: org_study_id