NCT00220051

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

First QC Date

September 19, 2005

Last Update Submit

May 30, 2013

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (2)

  • Pathological complete response rate.

  • Acute toxicity has been evaluated in previous phase I studies and should occur to a similar extent.

Secondary Outcomes (7)

  • Progression-free survival

  • Treatment related toxicity

  • Overall survival

  • Radiological response rate

  • Proportion of patients achieving pathological down staging compared with the pre-treatment MRI scan

  • +2 more secondary outcomes

Interventions

Oxaliplatin, CapecitabineDRUG
Pre operative radiotherapyPROCEDURE
Surgical ResectionPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20106720DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

OxaliplatinCapecitabine

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • D Cunningham

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

November 1, 2001

Last Updated

May 31, 2013

Record last verified: 2013-05