Non-Operative Management and Early Response Assessment in Rectal Cancer (NCT03904043) | Clinical Trial Compass
CompletedNot Applicable
Non-Operative Management and Early Response Assessment in Rectal Cancer
United States63 participantsStarted 2020-07-01
Plain-language summary
The investigators' data from a phase I study of short course radiation therapy followed by chemotherapy showed 74% complete clinical response (cCR). Given the promising response rate, the investigators are evaluating short course radiation therapy (SCRT) followed by chemotherapy in a multi-institution phase II trial to validate the cCR rate of this treatment paradigm. SCRT has not been prospectively evaluated in non-operative management for patients with non-metastatic rectal adenocarcinoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-2a, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including MRI
* Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy
* Clinically detectable (MR, endoscopy, or DRE) tumor present
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* At least 18 years of age
* Adequate bone marrow function defined as:
* Absolute neutrophil count (ANC) \> 1,500 cells/mm3
* Hemoglobin\> 8 g/dl
* Platelets \>100,000 cells/mm3
* 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
* Prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer.
* Prior oxaliplatin or capecitabine use for any malignancy
* No prior radiation therapy to the pelvis.
* A history of other malignancy (except non-melanomatous skin cancers) 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.
* Currently receiving any inves…
What they're measuring
1
Clinical Complete Response Rate
Timeframe: Completion of treatment (estimated to be 22 weeks)