Clinical trial NCT01060007: Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
Official title: A Phase II Evaluation of Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Neoplasms
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2010-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of T Stage Downstaging
timeFrame: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
measure: Preoperative Gastrointestinal Morbidity
timeFrame: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
Secondary outcomes:
measure: Incidence of Any Late Grade 3 or Higher Morbidity
timeFrame: Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks)
measure: Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity
timeFrame: 1 year (completion of all treatment)
measure: Local Control
timeFrame: 30 months
measure: Rate of Overall Control
timeFrame: 1 year
measure: Rate of Locoregional Control
timeFrame: 1 year
measure: Freedom From Disease Relapse
timeFrame: 30 months
measure: Determine Quality of Anorectal Function
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Parag Parikh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: