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

Rectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060007
• Other study ID #: 09-0696 / 201106272
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2010
• Last updated: January 23, 2015
• Start date: November 2009
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Radiation:
• External beam radiation

Drug:
• Oxaliplatin

• Leucovorin

• 5-FU

• Capecitabine

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	Yes
Secondary	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)	Yes
Secondary	Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity		1 year (completion of all treatment)	Yes
Secondary	Local Control	Kaplan-Meier projections	30 months	No
Secondary	Rate of Overall Control		1 year	No
Secondary	Rate of Locoregional Control		1 year	No
Secondary	Freedom From Disease Relapse	Kaplan-Meier projections.	30 months	No
Secondary	Determine Quality of Anorectal Function		1 year	No

External Links

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