Colorectal Cancer N1048/RTOG 1271

April 11, 2017

Sponsor: Alliance for Clinical Trials in Oncology

Number: N1048/RTOG 1271

The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-Fluorouracil/Capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation. There have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy. The study uses a combination regimen known as FOLFOX, (the drugs 5-Fluorouracil (5-FU), Oxaliplatin and Leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.

Who’s eligible:

  • The patient must have a diagnosis of rectal adenocarcinoma, with radiologically measurable or clinically evaluable disease.
  • The Eastern Cooperative Oncology Group (ECOG) performance status must be (PS): 0, 1 or 2.
  • ECOG status is used by your doctor in order to assess how your disease is progressing, assess how the disease effects of your daily living abilities, and determine appropriate treatment and prognosis.
  • The standard treatment recommendation in the absence of a clinical trial would be combined modality. The combined modality would be, neoadjuvant chemoradiation followed by curative intent surgical resection.
  • The patient must be a candidate for sphincter-sparing surgical resection prior to initiation of neoadjuvant (Treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery) therapy according to the primary surgeon. The clinical stage must be T2N1, T3N0, or T3N1 (Please see here for descriptions of staging). N2 disease is to be estimated as four or more lymph nodes that are >= 10 mm.
  • Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, computed tomography (CT) or positron emission tomography (PET)/CT scan of the chest/abdomen/pelvis and either a pelvic magnetic resonance imaging (MRI) or an ultrasound (endorectal ultrasound [ERUS]); if a pelvic MRI is performed, it is acceptable to perform CT of the chest/abdomen, omitting CT imaging of the pelvis
  • This study is for patients age 18 and older.

Available at: The Hospital of Central Connecticut, MidState Medical Center.

Cancer Clinical Research Office