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

NCT ID: NCT01060007

Last Updated: 2017-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2014-09-30

Brief Summary

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.

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.

Conditions

Rectal Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

External beam radiation

Intervention Type: RADIATION

Oxaliplatin

Intervention Type: DRUG

Leucovorin

Intervention Type: DRUG

5-FU

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Interventions

External beam radiation

Intervention Type: RADIATION

Oxaliplatin

Intervention Type: DRUG

Leucovorin

Intervention Type: DRUG

5-FU

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Other Intervention Names

Eloxatin; Fluorouracil; Efudex; Xeloda

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Parag Parikh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

09-0696 / 201106272

Identifier Type: -

Identifier Source: org_study_id