Hypofractionated Pencil-Beam Scanning Intensity-Modulated Proton Therapy for the Treatment of Recurrent Rectal Cancer, IMPARC Study

Status: closed to accrual and intervention

This clinical trial determines the best dose of hypofractionated pencil-beam scanning intensity-modulated proton therapy in treating patients with rectal cancer that has come back (recurrent). Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Radiation therapy uses high energy beam to kill tumor cells and shrink tumors.

Inclusion Criteria

History of biopsy-proven adenocarcinoma of the rectum, anus or rectosigmoid junction of any stage now with recurrent disease in the pelvis
One prior course of radiation therapy to the pelvis for rectal cancer
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
At least 18 years of age
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document

Exclusion Criteria

Patients with pre-existing radiosensitizing conditions, such as connective tissue disorders (i.e. lupus, scleroderma) and genetic mutations (i.e. ataxia-telangiectasia)
A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease, basal cell or squamous cell carcinoma of the skin that were treated with local resection only, or carcinoma in situ of the cervix. Patients with history of prostate cancer treated without radiotherapy and no evidence of disease are eligible
More than one prior course of radiation to the pelvis for rectal cancer
Prior radiation to the pelvis for disease other than rectal cancer
Tumor in the rectum/colon requiring radiation therapy to the full circumference of the rectum/colon
Current treatment with any investigational agents
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or unstable angina pectoris
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry

PRIMARY OBJECTIVE:

I. To determine the maximum tolerated dose (MTD) of reirradiation using hypofractionated intensity-modulated proton therapy (IMPT).

SECONDARY OBJECTIVES:

I. To determine the clinical complete response rate of patients with locoregionally recurrent rectal cancer who receive hypofractionated IMPT.

II. To estimate median freedom from locoregional progression (FFLP) in patients with locoregionally recurrent rectal cancer who receive hypofractionated IMPT.

III. To estimate median overall survival (OS) in patients with locoregionally recurrent rectal cancer who receive hypofractionated IMPT.

IV. To estimate median progression-free survival (PFS) in patients with locoregionally recurrent rectal cancer who receive hypofractionated IMPT.

V. To evaluate patient reported outcomes (PRO) in patients with locoregionally recurrent rectal cancer who receive hypofractionated IMPT via quality of life (QOL) questionnaires.

VI. To evaluate the toxicity profile of hypofractionated IMPT in patients with locoregionally recurrent rectal cancer.

EXPLORATORY OBJECTIVES:

I. To explore the prognostic value of serum squamous cell carcinoma antigen (SCCA) in patients with locoregionally recurrent rectal cancer who receive hypofractionated IMPT.

II. To evaluate the changes in serum inflammatory markers, C-reactive protein (CRP) and lactate dehydrogenase (LDH), in patients with locoregionally recurrent rectal cancer who receive hypofractionated IMPT.

OUTLINE: This is a dose-escalation study.

Patients undergo IMPT once daily (QD) on weekdays for 5 fractions in the absence of disease progression or unacceptable toxicity. Patients may also undergo colonoscopy, sigmoidoscopy, or proctoscopy and optional biopsy at screening. Additionally, patients undergo blood sample collection and magnetic resonance imaging (MRI), computed tomography (CT) or positron emission tomography (PET)/CT throughout the study.

After completion of study treatment, patients are followed up at 1-2 weeks, 6-8 weeks, 3, 6, 9, and 12 months.

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Hypofractionated Pencil-Beam Scanning Intensity-Modulated Proton Therapy for the Treatment of Recurrent Rectal Cancer, IMPARC Study

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