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A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Recta

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Trial Conditions
  • Colorectal Cancer
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with intensity-modulated radiation therapy works in treating patients undergoing surgery for locally advanced rectal cancer.

Date & Status

Active, not recruiting

Who can Participate?


18 and older




- Pathologically confirmed diagnosis of adenocarcinoma of the rectum by biopsy
technique that does not completely excise the lesion (e.g., fine needle aspiration,
core needle biopsy)

- Located up to 12 cm from the anal verge with no extension of malignant disease
into the anal canal

- Clinically determined to be stage T3 or T4,N0-N2, and M0 tumor as determined by
the following assessments:

- Colonoscopy and biopsy within 56 days prior to registration

- History/physical examination (including medication history screen for
contraindications) within 56 days prior to registration

- Contrast-enhanced imaging of the abdomen and pelvis either by CT, MRI, or
PET-CT (whole body preferred) within 56 days prior to registration

- Chest x-ray (or CT) of the chest within within 56 days prior to
registration to exclude distant metastases (except for patients who have
had whole body PET-CT)

- Transrectal ultrasound (TRUS) within 56 days prior to registration required
to establish tumor stage

- TRUS not required if clinical exam, CT of the pelvis, and/or MRI
demonstrates T4 lesion

- No synchronous primary colon carcinoma

- No evidence of distant metastases (M1)


Inclusion criteria:

- Zubrod performance status 0-2

- ANC (absolute neutrophil count) ≥ 1,800/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0
g/dL allowed)

- AST (aspartate aminotransferase) < 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase < 2.5 times ULN

- Bilirubin ≤ 1.5 times ULN

- Creatinine clearance > 50 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior invasive malignancy except nonmelanoma skin cancer unless disease free for a
minimum of 3 years

Exclusion criteria:

- Severe, active comorbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 12 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy within the past 30 days

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects


- 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, unless clinically stable on
anticoagulation therapy for ≥ 2 weeks

- Evidence of peripheral neuropathy ≥ grade 2

- Prior allergic reaction to oxaliplatin or capecitabine

- Lack of physical integrity of the gastrointestinal tract (i.e., severe Crohn 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 (i.e., capecitabine)

- Prior systemic chemotherapy for colorectal cancer (prior chemotherapy allowed
provided it was for a cancer other than colorectal cancer)

- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiotherapy fields

- Major surgery within 28 days of study enrollment(other than diverting colostomy
without tumor resection)

- Participation in any investigational drug study within 28 days of study enrollment.

- Concurrent cimetidine, amifostine, and/or depot Sandostatin

Gender: Both
Steward Physician(s)
  • Michael C. Garofalo, MD
  • Adam C. Berger, MD
  • Johanna Bendell, MD
  • Saint Anne's Hospital - Active, not recruiting
Trial Interventions
  • capecitabine
  • oxaliplatin
  • resection
  • radiation therapy
Physician Researcher

Investigator Name:

  • Michael C. Garofalo, MD
  • Adam C. Berger, MD
  • Johanna Bendell, MD

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 2
Trial ID: NCT00613080
Volunteers:  Not Accepting Healthy Volunteers

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