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


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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


OBJECTIVES:

Primary

- 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
cancer.

Secondary

- 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


DISEASE CHARACTERISTICS:

- Histologically or pathologically confirmed adenocarcinoma of the rectum

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

- 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

PATIENT CHARACTERISTICS:

- 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
therapy

PRIOR CONCURRENT THERAPY:

- 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:

Interventional

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:

No

Principal Investigator

Leonard B. Saltz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

07-021

NCT ID:

NCT00462501

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021