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Colorectal Cancer

Chemotherapy or Chemotherapy + Radiation for Rectal Cancer Patients Undergoing Surgery (The PROSPECT Trial)
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
Status Conditions Phase Study ID
Recruiting Colorectal Cancer Phase II/III NCT01515787
Summary

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.

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.


Investigator
Veena Shankaran, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

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 sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon
    • No patient for whom primary surgeon indicates need for abdominoperineal (APR) at baseline
  • Clinical stage T2N1, T3N0, T3N1 (stage IIA, IIIA, or IIIB)
    • Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, CT scan of the chest/abdomen/pelvis, and either a pelvic MRI or an ultrasound (ERUS)
      • Clinical stage N2 disease is to be estimated as four or more lymph nodes that are ≥ 10 mm
      • No clinical T4 tumors
  • Preoperative proctoscopy with tumor tissue evident between 5 and 12 cm from the anal verge, inclusive
    • No evidence that tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on pre-operative MRI or ERUS/pelvic CT scan
  • 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

Last Updated
January 23, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.