Organ Preservation in Early Rectal Cancer Patients

  • End date
    Mar 1, 2026
  • participants needed
  • sponsor
    Fox Chase Cancer Center
Updated on 21 April 2022
folfox regimen
transrectal ultrasound
pelvic mri
chemoradiation therapy
local excision
adenocarcinoma of rectum
total mesorectal excision


This is a single arm phase II study of neoadjuvant chemotherapy followed by local excision and post-operative chemoradiotherapy in patients with early stage, low rectal adenocarcinoma. After completion of pre-treatment tests/procedures (including pelvic MRI/ERUS; MRI is mandatory at baseline and other imaging is encouraged) and confirmation of eligibility, systemic therapy with FOLFOX will be administered for 12 weeks. 2 to 4 weeks after the chemotherapy, restaging of the primary tumor will be done to evaluate response to therapy (Pelvic MRI and /or sigmoidoscopy). Patients with disease progression or inadequate response to chemotherapy to allow local excision will continue with evaluation and treatment per the current standard of care (chemoradiation followed by TME). These patients will be considered failures for the primary endpoint of the study. Patients who respond to the neoadjuvant chemotherapy will proceed with local excision (open, TEMS or TAMIS), 6-12 weeks after the completion of neoadjuvant chemotherapy, followed by 5-FU based chemoradiotherapy 4-12 weeks after local excision. Patients with positive margins at the time of local excision will also be treated as per standard of care and will be considered as failures. Number of patients who can undergo successful local excision with this approach will define the success of the strategy. After chemoradiation therapy post local excision, patients will be followed closely every 3 months for the first 3 years and then every 2 months for the next 2 years (history/physical, CEA and pelvic MRI). Patients who are deemed failures for the primary end-point will be followed as per standard of care, off-study.

Condition Rectal Cancer
Treatment FOLFOX regimen
Clinical Study IdentifierNCT03548961
SponsorFox Chase Cancer Center
Last Modified on21 April 2022


Yes No Not Sure

Inclusion Criteria

Histologically proven adenocarcinoma of the lower rectum (lower border ≤6 cm from anal verge as assessed by pelvic MRI)
Clinical stage T1N0, T2N0, T3N0; high risk T1 and low risk T3 stage patients are also allowed. Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, CT Chest/Abdomen/Pelvis or PET/CT along with Pelvic MRI and Endoscopic Rectal Ultrasound (ERUS). If a pelvic MRI is performed, it is acceptable to perform CT of the chest/abdomen, omitting CT imaging of the pelvis
No prior therapy for rectal cancer
Age > 18 years
ECOG performance status 0 or 1
Patients must have normal organ and marrow function as defined below
Leukocytes > 3,000/mcL
Absolute neutrophil count > 1,500/mcL
Platelets > 100,000/mcL
Total bilirubin < 1.5 times ULN
AST/ALT (SGOT/SGPT) < 3 times institutional normal limits
Creatinine < 1.5 times ULN OR
Creatinine clearance > 60 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal
Ability to understand and willingness to sign a written informed consent and HIPAA
consent document

Exclusion Criteria

Patients with contraindication to use FOLFOX chemotherapy and pelvic radiation
Low risk T1 tumors that fulfill all of the following - size<4 cm, lack of lymphovascular invasion and well differentiated histology, are excluded
High risk T3 tumors that fulfill any of the following - circumferential tumor, extension into mesorectal fascia > 5mm, prediction of positive circumferential resection margin, are also excluded
T4, node positive or advanced rectal adenocarcinoma. Node positivity defined as nodes greater than 1cm in short axis with loss of uniform cortex/fatty hilum
Patients receiving other investigational agents
Patients who have had chemotherapy (for other malignancies) within 3 years prior to registration
Patients with any prior pelvic radiation therapy
Prior malignancies requiring systemic therapy within the last 3 years (as prior therapy can increase toxicity of current chemo regimen, those patients should be excluded)
History of allergic reactions attributed to compound of similar chemical or biologic composition to the agents used in this study
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with chemotherapeutic drugs. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
Pregnant or breast feeding
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