Clinical trial NCT04827732: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in Recurrent Rectal Cancer
Official title: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in the Reirradiation of Locoregionally Recurrent Rectal Cancer - IMPARC
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Recurrent Rectal Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine the maximum tolerated dose (MTD) of hypofractionated IMPT for the reirradiation of locoregionally recurrent rectal cancer.


Eligibility criteria: 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
* 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 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 outcomes:
measure: Maximum tolerated dose (MTD) of reirradiation using hypofractionated IMPT
timeFrame: Through 6 months from start of treatment for all participants enrolled (estimated to be 55 months)
Secondary outcomes:
measure: Clinical complete response rate
timeFrame: Within 6 weeks to 3 months post-completion of radiation therapy (estimated to be 7 weeks to 3 months and 1 week))
measure: Median freedom from locoregional progression (FFLP)
timeFrame: At 12 months post-radiation therapy (estimated to be 12 months and 1 week)
measure: Median overall survival (OS)
timeFrame: At 12 months post-radiation therapy (estimated to be 12 months and 1 week)
measure: Median progression-free survival (PFS)
timeFrame: At 12 months post-radiation therapy (estimated to be 12 months and 1 week)
measure: Change in quality of life as measured by the EORTC QLQ-C30
timeFrame: Prior to start of radiation therapy, 1-2 weeks post radiation therapy, 3 months post radiation therapy, 6 months post radiation therapy, 9 months post radiation therapy and 12 months post radiation therapy
measure: Change in quality of life as measured by the EORTC QLQ-CR29
timeFrame: Prior to start of radiation therapy, 1-2 weeks post radiation therapy, 3 months post radiation therapy, 6 months post radiation therapy, 9 months post radiation therapy and 12 months post radiation therapy
measure: Frequency of acute adverse events as measured by CTCAE v 5.0
timeFrame: From start of treatment through 3 months after completion of radiation therapy (estimated to be 3 months and 1 week)
measure: Frequency of late adverse events as measured by CTCAE v 5.0
timeFrame: From 3 month post-completion of radiation therapy to 12 months post-completion of radiation therapy
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Allen Mo, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: