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

Phase 2
21 Years
90 Years
Open (Enrolling)
Rectal Cancers.

Thank you

Trial Information

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

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

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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological complete response rates

Outcome Description:

Pathogical complete response rate 8 weeks post chemoradiotherapy at surgery according to Ryan's classification

Outcome Time Frame:

8 weeks post chemoradiotherapy

Safety Issue:


Principal Investigator

Jeremy Tey, FRANZCR

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

January 2011

Completion Date:

January 2013

Related Keywords:

  • Rectal Cancers.
  • Pathological complete response
  • Intensity modulated radiotherapy
  • Rectal cancer
  • Rectal Neoplasms