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Preoperative Concurrent Chemotherapy and Intensity Modulated Radiotherapy (IMRT) in Locally Advanced Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01340508
Recruitment Status : Unknown
Verified April 2011 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : April 22, 2011
Last Update Posted : April 22, 2011
Tan Tock Seng Hospital
Information provided by:
National University Hospital, Singapore

Brief Summary:
The hypothesis of this study is that dose escalated intensity modulated radiotherapy (IMRT) to a dose of 55Gy in 25# to primary rectal tumor concurrent with oral capecitabine results in an improved pathological response rate from 8% (German trial) to 25%.

Condition or disease Intervention/treatment Phase
Rectal Cancers. Radiation: Intensity Modulated Radiotherapy Phase 2

Detailed Description:
This study aims to look at whether radiation dose escalation with intensity modulated radiotherapy can increase the rates of pathological complete response in patients with locally advanced rectal cancer treated with neoadjuvant chemoradiotherapy

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Preoperative Concurrent Chemotherapy and (IMRT) in Locally Advanced Rectal Cancer
Study Start Date : January 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Arm Intervention/treatment
Experimental: Intensity modulated Radiotherapy
Intensity modulated radiotherapy, dose escalation, rectal cancer, volumetric modulated arc therapy
Radiation: Intensity Modulated Radiotherapy
Intensity modulated radiotherapy to a dose of 55Gy in 25 fractions
Other Name: Intensity modulated radiotherapy. Dose escalation.

Primary Outcome Measures :
  1. Pathological complete response rates [ Time Frame: 8 weeks post chemoradiotherapy ]
    Pathogical complete response rate 8 weeks post chemoradiotherapy at surgery according to Ryan's classification

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 2 years ]
    Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis, proctitis, urinary frequency/urgency as per common toxicity criteria v3.0

  2. Disease Free survival [ Time Frame: 2 years ]
    Time from study entry to disease recurrence or death

  3. Downstaging rates [ Time Frame: 8 weeks after chemoradiotherapy ]
    percentage of patients who achieve downstaging 8 weeks post chemoradiotherapy at surgery according to TNM classification

  4. Sphincter Preservation rates [ Time Frame: 8 weeks after chemoradiotherapy ]
    Sphincter Preservation rates 8 weeks post chemoradiotherapy at surgery.Percentage of patients who underwent sphincter salvage surgery after chemoradiotherapy

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pathologically proven diagnosis of adenocarcinoma of the rectum
  • Clinically determined to be stage T3 or T4,N0-N2, and M0 -staged by MRI or transrectal ultrasound of the rectum
  • Patients who are medically operable and who have resectable adenocarcinoma of the rectum at least <15cm from the anal verge
  • Adequate liver/renal and haematological function.
  • Eastern Cooperative Oncology Group (ECOG) performance 0-2
  • Age ≥ 18 years
  • Full blood count obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:

    • Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
    • Platelets ≥ 100,000 cells/mm3
    • Haemoglobin ≥ 8.0 g/dl
  • Serum creatinine within normal institutional limits or creatinine clearance ≥ 50 ml/min
  • Bilirubin within normal institutional limits
  • AST and ALT < 2.5 x the IULN
  • Patient must sign study specific informed consent prior to study entry

Exclusion Criteria:

Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years

  • Prior systemic chemotherapy for colorectal cancer; note that prior chemotherapy for a different cancer is allowable.
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Severe, active comorbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months
    • Transmural myocardial infarction within the last 6 months
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
    • Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol.
    • Evidence of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake.
    • Known, existing uncontrolled coagulopathy. Patients on therapeutic anticoagulation may be enrolled provided that they have been clinically stable on anti-coagulation for at least 2 weeks.
    • Major surgery within 28 days of study enrollment (other than diverting colostomy)
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
  • Prior allergic reaction to capecitabine
  • Any evidence of distant metastases (M1)
  • A synchronous primary colon carcinoma
  • Extension of malignant disease into the anal canal
  • Lack of physical integrity of the gastrointestinal tract (i.e., severe Crohn's disease that results in
  • malabsorption; significant bowel resection that would make one concerned about the absorption of capecitabine) or malabsorption syndrome that would preclude feasibility of oral chemotherapy (capecitabine)
  • Participation in any investigational drug study within 28 days of study enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01340508

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National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Jeremy Tey, FRANZCR    + 6567724869   
Principal Investigator: Jeremy Tey, FRANZCR         
Sponsors and Collaborators
National University Hospital, Singapore
Tan Tock Seng Hospital
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Principal Investigator: Jeremy Tey, FRANZCR National University Hospital, Singapore

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Responsible Party: Dr Jeremy Tey, National University Hospital Identifier: NCT01340508     History of Changes
Other Study ID Numbers: B/09/377
First Posted: April 22, 2011    Key Record Dates
Last Update Posted: April 22, 2011
Last Verified: April 2011
Keywords provided by National University Hospital, Singapore:
Pathological complete response
Intensity modulated radiotherapy
Rectal cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases