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

NCT01060007 | Completed Phase 2 Results

• 1 other identifier: 09-0696 / 201106272
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• Rate of T Stage Downstaging

  T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT).

  Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)

• Preoperative Gastrointestinal Morbidity

  As measured by participants who experience grade 3 or higher gastrointestinal morbidity

  Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)

Secondary Outcomes (7)

• Incidence of Any Late Grade 3 or Higher Morbidity

  Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks)

• Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity

  1 year (completion of all treatment)

• Local Control

  30 months

• Rate of Overall Control

  1 year

• Rate of Locoregional Control

  1 year

Study Arms (1)

Neoadjuvant radiation followed by FOLFOX

EXPERIMENTAL

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; Drug: Leucovorin; Drug: 5-FU; Drug: Capecitabine

Interventions

External beam radiation RADIATION

Neoadjuvant radiation followed by FOLFOX

Oxaliplatin DRUG

Also known as: Eloxatin

Neoadjuvant radiation followed by FOLFOX

Leucovorin DRUG

Neoadjuvant radiation followed by FOLFOX

5-FU DRUG

Also known as: Fluorouracil, Efudex

Neoadjuvant radiation followed by FOLFOX

Capecitabine DRUG

Also known as: Xeloda

Neoadjuvant radiation followed by FOLFOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Oxaliplatin; Leucovorin; Fluorouracil; Capecitabine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Parag Parikh, M.D.
• Organization: Washington University School of Medicine

pparikh@radonc.wustl.edu

314-362-9703

Study Officials

• Parag Parikh, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: February 1, 2010
• Study Start: November 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: September 1, 2014
• Last Updated: March 8, 2017
• Results First Posted: February 10, 2015

Record last verified: 2017-01

Locations

US (1)