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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01060007
First received: January 28, 2010
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

To determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU, oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy.


Condition Intervention Phase
Rectal Neoplasms
 Radiation: External beam radiation
Drug: Oxaliplatin
Drug: Leucovorin
Drug: 5-FU
Drug: Capecitabine
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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. [ Time Frame: 12-18 weeks after start of radiation therapy ] [ Designated as safety issue: No ]
    Time of surgery

  • Demonstrate that short course preoperative radiotherapy followed by preoperative chemotherapy will lead to acute gastrointestinal morbidity comparable to or better than seen with concurrent prolonged course preoperative radiotherapy and chemotherapy. [ Time Frame: 12-18 weeks after start of radiation therapy ] [ Designated as safety issue: Yes ]
    Time of surgery


Secondary Outcome Measures:
  • Determine the incidence of any grade 3 or higher morbidity during preoperative treatment [ Time Frame: 9 weeks after start of radiation therapy ] [ Designated as safety issue: Yes ]
  • Determine the incidence of post chemoradiotherapy grade 3 or higher morbidity at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Determine tumor locoregional and overall control at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Determine quality of anorectal function at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: November 2009
Estimated Study Completion Date: September 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neoadjuvant radiation followed by FOLFOX

Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.

FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).

If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.

 Radiation: External beam radiation Drug: Oxaliplatin
Other Name: Eloxatin
Drug: Leucovorin Drug: 5-FU
Other Names:
  • Fluorouracil
  • Efudex
Drug: Capecitabine
Other Name: Xeloda

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 conditions

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060007

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Parag Parikh, M.D. Washington University School of Medicine
  More Information

Additional Information:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01060007     History of Changes
Other Study ID Numbers: 09-0696 / 201106272
Study First Received: January 28, 2010
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Capecitabine
Oxaliplatin
Leucovorin
 Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes

ClinicalTrials.gov processed this record on May 19, 2013