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| ID | Type | Description | Link |
|---|---|---|---|
| 25-1024 | Other Identifier | FCCC IRB |
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| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
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The goal of this clinical trial is to find out if giving extra adaptive radiation therapy after standard chemoradiation treatment is safe and helpful for people with rectal cancer.
The main questions the study aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive Radiotherapy Boost Following Standard Pelvic Chemoradiation | Experimental | Adaptive Radiotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive Radiotherapy Boost | Radiation | Patients will receive one boost fraction every two weeks, targeting the primary tumor within the rectum plus a 2 mm Planning Target Volume (PTV) margin. Any regional lymph nodes that measure at least 5 mm in short axis on the day of treatment will receive treatment with the ART dose being given to the primary rectal tumor. |
| Measure | Description | Time Frame |
|---|---|---|
| MTD will be evaluated by monitoring the rate of dose limiting toxicities (DLTs) defined as acute Grade 2+ gastrointestinal toxicity probably or definitely related to radiation. | From the initiation of rectal adaptive radiotherapy boost to 90 days after the last dose of boost, for a total of ~ 120 days. | |
| Feasibility of a rectal boost that targets at least 90% of the rectal planning tumor volume with the 80% prescribed dose while limiting the outer 3 mm of the rectal wall to no more than 50% of the prescription dose delivered to 0.1cc. | Feasibility will be determined based on successful implementation and completion of standard chemoradiotherapy followed by experimental rectal adaptive radiotherapy boost utilizing CT-MR fusion that targets at least 90% of the rectal PTV_Eval with the 80% prescribed dose while limiting the outer 3 mm of the rectal wall to no more than 50% of the prescription dose delivered to 0.1cc in ≥ 70% of ART fractions for the patient population enrolled in the study. This will be assessed at the MTD. | From the ART boost initiation to the end of the ART boost, for a period of ~ 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the efficacy of bi-weekly adaptive radiotherapy boost fractions by complete response rate, near complete response rate, and incomplete response rate as per Memorial Sloan Kettering Cancer Center (MSKCC) criteria. | From the end of rectal adaptive radiotherapy boost to the end of study, for a total of ~ 5 years. | |
| Estimate total mesorectal excision (TME) free survival following treatment with the study regimen. |
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Inclusion Criteria:
Subjects must have histologically or cytologically confirmed rectal adenocarcinoma.
Subjects must have T2-3, N0-1, M0 rectal cancer. Staging will be done by MRI pelvis and CT chest and abdomen with contrast. PET-CT will be an acceptable alternative for the CT chest and abdomen.
Subjects must be willing to undergo MRI scans.
Age ≥18 years.
ECOG performance status 0 or 1.
Estimated survival of ≥ 12 months.
Subjects must have normal organ and marrow function as defined below
Subjects must be able to tolerate the chemotherapy regimens outlined in the treatment plan (Section 5.0), both before and after ART.
Subjects must possess the ability to understand and willingness to sign a written informed consent and HIPAA consent document. Translation services including translation of informed consent documents will be provided, as feasible, to encourage diversity of inclusion of eligible patients.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joshua Meyer, MD | Contact | 215-728-2667 | Joshua.Meyer@fccc.edu | |
| Jianli Hu, MD, PhD | Contact | 267-449-1431 | Jianli.Hu@fccc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joshua Meyer | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19111 | United States |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| From the end of treatment to the end of the study, for a total of up to 5 years. |
| Estimate overall survival (OS) following treatment with the study regimen. | From the end of treatment to the end of study, for a total of up to 5 years. |
| Estimate early and late toxicity following treatment with the study regimen. | From the initiation of rectal radiation boost treatment to the end of the study, for a total of ~ 5 years. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |