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Phase I Study of Preoperative Radiation Therapy With Concurrent Protracted Continuous Infusion 5-FU and Dose Escalating Oxaliplatin Followed by Surgery, 5-FU, and Leucovorin for Locally Advanced (T3 and T4) Rectal Adenocarcinoma (NCT00003799)

Phase I trial to study the effectiveness of radiation therapy plus chemotherapy followed by surgery and additional chemotherapy in treating patients who have advanced nonmetastatic primary cancer of the rectum. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may be an effective treatment for rectal cancer
  • Drug: fluorouracil
    Given IV
    • 5-fluorouracil
    • 5-Fluracil
    • 5-FU
  • Drug: oxaliplatin
    Given IV
    • 1-OHP
    • Dacotin
    • Dacplat
    • Eloxatin
    • L-OHP
  • Radiation: radiation therapy
    Undergo radiotherapy
    • irradiation
    • radiotherapy
    • therapy, radiation
  • Drug: leucovorin calcium
    Given IV
    • CF
    • CFR
    • LV
  • Procedure: therapeutic conventional surgery
    Undergo surgery
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers

    I. To identify maximally tolerated dose (MTD) and dose limiting toxicity (DLT) of oxaliplatin when combined preoperatively with concurrent radiation therapy (XRT) and fluorouracil (5-FU) by PVI.

    II. To evaluate the resection rate for T4 rectal cancers, the pathologic CR rate for T3 and T4 rectal cancers, and the expected versus actual type of resection (APR vs. LAR vs. LAR/coloanal anastomosis).

    III. To make preliminary observations of patient survival and patterns of recurrence for this treatment combination.

    IV. To evaluate anastomotic and sphincter function following pre-op combined modality therapy.

    OUTLINE: This is a dose-escalation study of preoperative oxaliplatin.

    Patients receive fluorouracil IV continuously with concurrent radiotherapy for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on day 1 of weeks 1, 3, and 5.

    Cohorts of 5 patients each receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose-limiting toxicity. Additional patients are treated at the MTD.

    Patients undergo surgery 6-8 weeks after completing preoperative chemotherapy and radiotherapy. The surgical procedure is determined by the extent of the tumor before preoperative therapy. The type of operative procedure may be abdominoperineal resection, low anterior resection (LAR), or LAR/coloanal anastomosis.

    Postoperative chemotherapy begins within 6 weeks after surgery, comprising leucovorin calcium and fluorouracil IV on days 1-5. Treatment repeats every 21 days for 4 courses.

    Patients are followed every 3 months for 2.5 years, every 6 months for 3 years, then annually for 5 years.

    1 locations

    United States (1)
    • Eastern Cooperative Oncology Group
      Not specified
      Boston, Massachusetts, United States, 02215
    30 April, 1999
    08 January, 2013
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