A Phase II Trial of Preoperative Concurrent Chemotherapy and (IMRT) in Locally Advanced Rectal Cancer

National University Hospital, Singapore1 site in 1 country63 target enrollmentJanuary 2011

ConditionsRectal Cancers.

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Rectal Cancers.
Sponsor: National University Hospital, Singapore
Enrollment: 63
Locations: 1
Primary Endpoint: Pathological complete response rates
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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%.

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

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

January 2013

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

National University Hospital, Singapore

Eligibility Criteria

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

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.