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Active Clinical Trials

N1048

Active NCT:
01515787
Allegheny Valley Hospital
Allegheny Valley Hospital

Allegheny General Hospital
Allegheny General Hospital

Forbes Hospital
Forbes Hospital

Jefferson Hospital
Jefferson Hospital

Sponsor: 
Alliance for Clinical Trials in Oncology
Contact: 

For more information, please contact Luann Healy by telephone at 412-359-8420 or email at Luann.Healy@ahn.org or Julie Russo by telephone at 412-359-6851 or email Julie.Russo@ahn.org.

N1048: A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision.

Purpose: 

This randomized phase II/III trial studies how well chemotherapy alone compared to chemotherapy plus radiation therapy works in treating patients with rectal cancer undergoing surgery.
Rationale: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy alone is more effective then chemotherapy plus radiation therapy in treating rectal cancer.

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

  • Diagnosis of rectal adenocarcinoma
  • Radiologically measurable or clinically evaluable disease
  • For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined-modality, neoadjuvant chemoradiation followed by curative-intent surgical resection
  • Candidate for sphier-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon
  • Clinical stage T2N1, T3N0, T3N1 (stage IIA, IIIA, or IIIB)
  • Preoperative proctoscopy with tumor tissue evident between 5 and 12 cm from the anal verge, inclusive
  • No tumor causing symptomatic bowel obstruction

PATIENT CHARACTERISTICS:

  • ECOG performance status 0, 1, or 2
  • Absolute neutrophil count (ANC) ≥ 1,500/mm3
  • Platelets ≥ 100,000/mm3
  • Hemoglobin > 8.0 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤3 times ULN
  • Creatinine ≤1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Patient of child-bearing potential is willing to employ adequate contraception
  • Willing to return to enrolling medical site for all study assessments
  • No other invasive malignancy ≤ 5 years prior to registration; exceptions are colonic polyps, non-melanoma skin cancer, or carcinoma-in-situ of the cervix
  • No co-morbid illnesses or other concurrent disease that, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

PRIOR CONCURRENT THERAPY:
See Disease Characteristics

  • No chemotherapy within 5 years prior to registration (hormonal therapy is allowable if the disease-free interval is ≥ 5 years)
  • No prior pelvic radiation