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