Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer Undergoing Surgery

Overview

  • Study type

    Interventional
  • Study phase

    II/III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 11-007364
    • Scottsdale/Phoenix, Arizona: 11-007364
    NCT ID: NCT01515787
    Sponsor Protocol Number: N1048

About this study

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 to treat patients with advanced colorectal cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Study closed to enrollment

Registration Inclusion Criteria:

  1. Age ≥ 18 years at diagnosis
  2. Diagnosis of rectal adenocarcinoma
  3. Radiologically measurable or clinically evaluable disease as defined in the protocol
  4. ECOG Performance Status (PS): 0, 1 or 2
  5. 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
  6. Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon
  7. Primary surgeon is credentialed or is willing to be credentialed in Total Mesorectal Excision (TME), which entails submission of photos of a single TME specimen either before enrolling the first patient or by using the surgeon's 1st accrued case.
  8. Clinical Stage: T2N1, T3N0, T3N1. 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 ≥ 10mm
  9. The following laboratory values obtained ≤ 28 days prior to registration:
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3
    • Platelet count ≥ 100,000/mm^3
    • 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
  10. Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
  11. Patient of child-bearing potential is willing to employ adequate contraception.
  12. Provide informed written consent
  13. Willing to return to enrolling medical site for all study assessments

Registration Exclusion Criteria:

  1. Clinical T4 tumors
  2. Primary surgeon indicates need for abdominoperineal (APR) at baseline
  3. 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 with negative margins 
  4. Tumor is causing symptomatic bowel obstruction (patients who have had a temporary diverting ostomy are eligible).
  5. Chemotherapy within 5 years prior to registration. Hormonal therapy is allowable if the disease free interval is ≥ 5 years.
  6. Any prior pelvic radiation
  7. Other invasive malignancy ≤ 5 years prior to registration. Exceptions are colonic polyps, non-melanoma skin cancer or carcinoma in-situ of the cervix.
  8. Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects.
    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
  9. 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert McWilliams, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Robert McWilliams, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20116117

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