Non-Operative Management and Early Response Assessment in Rectal Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Adenocarcinoma of the Lower Rectum

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiation + FOLFOX

* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).

* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted

Group Type EXPERIMENTAL

Radiation therapy

Intervention Type RADIATION

-Monday-Friday treatment is strongly recommended

FOLFOX regimen

Intervention Type DRUG

-CAPOX can be given as alternative

Radiation + CAPOX

* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).

* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted

Group Type EXPERIMENTAL

Radiation therapy

Intervention Type RADIATION

-Monday-Friday treatment is strongly recommended

CAPOX regimen

Intervention Type DRUG

Given as an alternative to FOLFOX

Interventions

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Radiation therapy

-Monday-Friday treatment is strongly recommended

Intervention Type RADIATION

FOLFOX regimen

-CAPOX can be given as alternative

Intervention Type DRUG

CAPOX regimen

Given as an alternative to FOLFOX

Intervention Type DRUG

Eligibility Criteria

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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 investigational agents.
* A history of allergic reaction attributed to compounds of similar chemical or biologic composition to capecitabine, 5FU, oxaliplatin, or leucovorin.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
* Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended. HIV testing for patients without a history of HIV is not a protocol requirement.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No