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A Pilot Study of Neoadjuvant Chemotherapy With Selective Use of Radiation for Locally Advanced Rectal Cancer

18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

A Pilot Study of Neoadjuvant Chemotherapy With Selective Use of Radiation for Locally Advanced Rectal Cancer



- Determine whether neoadjuvant chemotherapy comprising oxaliplatin, fluorouracil,
leucovorin calcium (FOLFOX), and bevacizumab can be substituted for pelvic radiotherapy
without compromising R0 resection rates in patients with locally advanced rectal


- Determine whether a 3-year local recurrence rate of ≤ 10% can be achieved in patients
treated with this regimen.

- Determine the proportion of patients who achieve a complete pathologic response after
treatment with this regimen.

OUTLINE: This is a non-randomized, open-label, pilot study.

- Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours, leucovorin
calcium IV over 2 hours, and bevacizumab IV over 10 minutes on day 1 and fluorouracil
IV continuously over 48 hours on days 1 and 2 in weeks 1, 3, 5, and 7. Patients then
receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and
fluorouracil IV continuously over 48 hours on days 1 and 2 in weeks 9 and 11. Treatment
continues in the absence of disease progression or unacceptable toxicity.

Within 3 weeks after completion of neoadjuvant chemotherapy, patients undergo restaging
evaluation. Patients with no evidence of disease progression by endorectal ultrasound
(ERUS), pelvic MRI, and CT scan of the chest/abdomen AND who remain candidates for R0
resection may proceed directly to surgical resection within 4-6 weeks after completion of
neoadjuvant chemotherapy. Patients with progressive disease who are not candidates for an R0
resection, proceed to neoadjuvant chemoradiotherapy.

- Neoadjuvant chemoradiotherapy: Patients undergo pelvic radiotherapy 5 days a week and
receive concurrent fluorouracil IV continuously for 5½ weeks. Within 4-7 weeks after
completion of chemoradiotherapy, patients undergo surgical resection.

After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Inclusion Criteria


- Histologically or pathologically confirmed adenocarcinoma of the rectum

- Clinical stage T1, N1; T2, N1; T3, N0; or T3, N1 by endorectal ultrasonography

- No bulky N2 disease by either ERUS or MRI

- No primary fixed or unresectable (clinical stage T4) rectal cancer or
recurrent colorectal cancer limited to the pelvis

- Primary unresectable rectal cancer is defined as a primary rectal
tumor which on the basis of either physical exam, ERUS or pelvic MRI
is deemed to be adherent or fixed to adjacent pelvic structures

- Must be a candidate for all of the following:

- Neoadjuvant chemoradiotherapy

- Systemic therapy with fluorouracil, leucovorin calcium, oxaliplatin (FOLFOX),
and bevacizumab

- Complete surgical resection via low anterior resection prior to administration
of any therapy

- No low-lying tumors deemed to require an abdominal perineal resection

- No large or bulky tumors that require a diverting colostomy or placement of an
endorectal stent prior to treatment initiation

- No clinical evidence of metastatic disease


- ECOG performance status 0-2

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count > 150,000/mm^3

- Hemoglobin > 8.0 g/dL

- Creatinine ≤ 1.5 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 4 weeks after
completion of study therapy

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- No arterial thrombotic event within the past 6 months, including stable or unstable
angina, myocardial infarction (MI), or cerebral vascular accident (CVA)

- Deep venous thrombosis, pulmonary embolus, MI, CVA, atrial fibrillation, or any
other conditions occurring more than 6 months ago allowed provided patient is on
stable doses of anticoagulant therapy

- No other medical or psychiatric condition or disease that would preclude study


- See Disease Characteristics

- No prior chemotherapy or surgery for rectal cancer

- No prior pelvic radiotherapy

- No other concurrent experimental therapy, including any of the following:

- Chemotherapy

- Radiotherapy

- Hormonal therapy

- Antibody therapy

- Immunotherapy

- Gene therapy

- Vaccine therapy

- Angiogenesis inhibitors

- Matrix metalloprotease inhibitors

- Thalidomide

- Anti-vascular endothelial growth factor/Flk-1 monoclonal antibody

- Any other experimental drugs

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:

R0 resection rate

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Leonard B. Saltz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2007

Completion Date:

December 2013

Related Keywords:

  • Colorectal Cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • adenocarcinoma of the rectum
  • Rectal Neoplasms
  • Colorectal Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021