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Status:

UNKNOWN

Oxaliplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients Undergoing Surgery for High-Risk Rectal Cancer

Lead Sponsor:

Royal Marsden NHS Foundation Trust

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Ra...

Detailed Description

OBJECTIVES: * Compare the pathological complete response rate at total mesorectal excision in patients with high-risk rectal cancer treated with neoadjuvant therapy comprising oxaliplatin, capecitabi...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed adenocarcinoma or undifferentiated non-small cell carcinoma of the rectum
  • MRI-defined high-risk, operable disease, defined by ≥ 1 of the following:
  • Tumors within 1 mm of mesorectal fascia (i.e., circumferential resection margin threatened or involved)
  • T3 tumors at or below levators
  • Tumors extending ≥ 5 mm into perirectal fat
  • T4 tumors
  • Presence of extramural venous invasion (primary tumor is therefore at least T3)
  • No evidence of metastatic disease by CT scan of the chest and abdomen or, if required, by positron emission tomography scan or biopsy
  • No rectal cancer that is unlikely to be operable even after neoadjuvant treatment (i.e., tumor involving the internal iliac vessels)
  • No T1-2 rectal cancer, in the absence of other high-risk factors
  • T2 tumors within 1 mm of mesorectal fascia allowed
  • No recurrent disease
  • PATIENT CHARACTERISTICS:
  • WHO performance status 0-2
  • Life expectancy \> 3 months
  • WBC \> 3,000/mm³
  • Absolute neutrophil count \> 1,500/mm³
  • Platelet count \> 100,000/mm³
  • Bilirubin \< 1.5 times upper limit of normal (ULN)
  • Transaminases \< 2.5 times ULN
  • Creatinine normal OR creatinine clearance \> 50 mL/min
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No concurrent uncontrolled medical condition
  • No other active malignant disease within the past 10 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No contraindications to MRI (e.g., pacemaker)
  • No medical or psychiatric conditions that would preclude informed consent
  • No known malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract
  • No clinically significant (i.e., active) cardiac disease, including any of the following:
  • Congestive heart failure
  • Symptomatic coronary artery disease
  • Cardiac dysrhythmia (e.g., atrial fibrillation, even if controlled with medication)
  • Myocardial infarction within the past 12 months
  • No symptoms or history of peripheral neuropathy
  • PRIOR CONCURRENT THERAPY:
  • No prior chemotherapy, radiotherapy, or investigational treatment for rectal cancer
  • No other concurrent cytotoxic agents or investigational drugs
  • No concurrent sorivudine or sorivudine analogues (e.g., brivudine)

Exclusion

    Key Trial Info

    Start Date :

    September 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    164 Patients enrolled

    Trial Details

    Trial ID

    NCT00383695

    Start Date

    September 1 2005

    Last Update

    January 13 2010

    Active Locations (13)

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    Page 1 of 4 (13 locations)

    1

    Vall d'Hebron University Hospital

    Barcelona, Spain, 08035

    2

    Hospital Universitario La Paz

    Madrid, Spain, 28046

    3

    Hospital Clinico Universitario de Valencia

    Valencia, Spain, 46010

    4

    Karolinska University Hospital - Solna

    Stockholm, Sweden, S-171 76