Colorectal

General Information



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 (PROSPECT)
Adult
NCT01515787
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 and 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 using 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 since 2002 to treat patients with advanced colorectal cancer.




Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Fairfax Colon and Rectal Surgery
2710 Prosperity Avenue, Suite 200
Fairfax, VA 22031

Virginia Cancer Specialists
8503 Arlington Boulevard, Suite 400
Fairfax, VA 22031

Eligibility Information

  • Age ≥ 18 years at diagnosis
  • Diagnosis of rectal adenocarcinoma
  • Radiologically measurable or clinically evaluable disease
  • ECOG Performance Status (PS): 0, 1 or 2
  • 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 sphincter-sparing surgical resection prior to initiation of neoadjuvant therapy according to the primary surgeon
  • Clinical Stage: T2N1, T3N0, T3N1
    • 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, CT or PET/CT scan of the chest/abdomen/pelvis and either a pelvic MRI or an ultrasound (ERUS). If a pelvic MRI is performed, it is acceptable to perform CT of the chest/abdomen, omitting CT imaging of the pelvis.
  • The following laboratory values obtained ≤ 28 days prior to registration
    • Absolute neutrophil count (ANC) ≥ 1500/mm3
    • Platelet count ≥ 100,000/mm3
    • Hemoglobin > 8.0 g/dL
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
    • SGOT (AST) ≤ 3 x ULN
    • SGPT (ALT) ≤ 3 x ULN
    • Creatinine ≤1.5 x ULN
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
  • Patient of child-bearing potential is willing to employ adequate contraception
  • Provide informed written consent
  • Willing to return to enrolling medical site for all study assessments
  • Additional eligibility in protocol

Ineligibility Information

  • Clinical T4 tumors
  • Primary surgeon indicates need for abdominoperineal (APR) at baseline
  • Evidence that the tumor is adherent to or invading the mesorectal fascia on imaging studies such that the surgeon would not be able to perform an R0 resection (one with negative margins)
  • Tumor is causing symptomatic bowel obstruction (patients who have had a temporary diverting ostomy are eligible)
  • Chemotherapy within 5 years prior to registration. (Hormonal therapy is allowable if the disease free interval is ≥ 5 years.)
  • Any prior pelvic radiation
  • Other invasive malignancy ≤ 5 years prior to registration. Exceptions are colonic polyps, non-melanoma skin cancer or carcinoma-in-situ of the cervix.
  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
    • Co-morbid illnesses or other concurrent disease which, 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

     

Contact Information


Lindsey Tishman, MHA, CCRC


571-472-0633
lindsey.tishman@inova.org

For more information go to https://clinicaltrials.gov/ct2/show/NCT01515787?term=NCT01515787&rank=1