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A Phase II Evaluation of Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer

Phase 2
18 Years
Open (Enrolling)
Rectal Neoplasms

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Trial Information

A Phase II Evaluation of Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer

Our principal objectives in this trial will be to determine if short course radiotherapy
followed by chemotherapy can maintain morbidity at or below levels reported with concurrent
5FU (oral capecitabine if 5FU is unavailable), oxaliplatin, and radiotherapy, while
maintaining response rates comparable to what would be expected with radiotherapy and
concurrent chemotherapy. If we can establish a T stage downstaging rate that is
significantly better than 50% and if acute tolerance is acceptable, then we would consider
this study as having provided sufficient pilot data to support including this approach as an
arm in a multi-institution phase III trial. The long-term goal is improved overall control
of disease by delivering better chemotherapy earlier.

Inclusion Criteria:

- Biopsy proven adenocarcinoma of the rectum

- Patient evaluated by surgeon and found to be a potential surgical candidate. Since
the primary objectives are response to chemoradiation and acute toxicity, lesions
which are initially unresectable are eligible—provided the surgeon feels that, if
there is sufficient response, surgery could become feasible.

- Clinical evidence of T3 or T4 disease. This can be by imaging studies (see or by
physical findings (tethering on palpation for T3 lesions or invasion of a neighboring
organ for T4 lesions)

- Karnofsky Performance Status at >60

- Laboratory criteria:

- Absolute neutrophil count >= 1.5 K

- Platelets >= 100 K

- Total Bilirubin <= 2.0;

- SGOT and Alkaline Phosphatase <= 2 x upper limit of normal

- Creatinine < 2.0

- Hemoglobin >= 8.0

- Informed consent signed

- Tumor measurable in at least one dimension. This may be, e.g. length and/or width
measured endoscopically or on digital rectal examination, and maximum rectal wall
thickness determined by imaging studies.

- Estimated longevity at least 12 months

- Patients with distant metastatic disease will be eligible if they satisfy all other

Exclusion Criteria:

- Pregnant women, children < 18 years, or patients unable to give informed consent

- Patients with a past history of pelvic radiotherapy.

- Patients with any other malignancy within the past 5 years except: skin cancer or
in-situ cervical cancer

- Patients with known allergy/intolerance to 5FU, Leucovorin, Oxaliplatin, Capecitabine

- Prior chemotherapy for colorectal cancer.

- Grade >= 2 peripheral neuropathy

- Any condition which, in the opinion of the treating medical oncologist, renders the
patient unfit for 5FU (oral capecitabine if 5FU is unavailable), Leucovorin,
Oxaliplatin chemotherapy

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Demonstrate that short course preoperative radiotherapy followed by preoperative chemotherapy will elicit a rate of T stage downstaging comparable to or better than seen with concurrent prolonged course preoperative radiotherapy and chemotherapy.

Outcome Description:

Time of surgery

Outcome Time Frame:

12-18 weeks after start of radiation therapy

Safety Issue:


Principal Investigator

Parag Parikh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:

09-0696 / 201106272



Start Date:

November 2009

Completion Date:

September 2014

Related Keywords:

  • Rectal Neoplasms
  • Neoplasms
  • Rectal Neoplasms



Washington University School of MedicineSaint Louis, Missouri  63110