Organ Preservation in Early Rectal Cancer Patients

Last updated: April 3, 2025
Sponsor: Fox Chase Cancer Center
Overall Status: Active - Not Recruiting

Phase

2

Condition

Rectal Cancer

Colorectal Cancer

Colon Cancer

Treatment

FOLFOX regimen

Clinical Study ID

NCT03548961
GI-116
18-1013
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion criteria

  1. Histologically proven adenocarcinoma of the lower rectum (lower border ≤6 cm fromanal verge as assessed by pelvic MRI).

  2. Clinical stage T1N0, T2N0, T3N0; high risk T1 and low risk T3 stage patients arealso allowed. Clinical staging should be estimated based on the combination of thefollowing assessments: physical exam by the primary surgeon, CT Chest/Abdomen/Pelvisor PET/CT along with Pelvic MRI and Endoscopic Rectal Ultrasound (ERUS). If a pelvicMRI is performed, it is acceptable to perform CT of the chest/abdomen, omitting CTimaging of the pelvis.

  3. No prior therapy for rectal cancer

  4. Age > 18 years.

  5. ECOG performance status 0 or 1

  6. 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 levelsabove institutional normal

  1. Ability to understand and willingness to sign a written informed consent and HIPAAconsent document

Exclusion

Exclusion Criteria:

  1. Patients with contraindication to use FOLFOX chemotherapy and pelvic radiation.

  2. Low risk T1 tumors that fulfill all of the following - size<4 cm, lack oflymphovascular invasion and well differentiated histology, are excluded

  3. High risk T3 tumors that fulfill any of the following - circumferential tumor,extension into mesorectal fascia > 5mm, prediction of positive circumferentialresection margin, are also excluded.

  4. T4, node positive or advanced rectal adenocarcinoma. Node positivity defined asnodes greater than 1cm in short axis with loss of uniform cortex/fatty hilum

  5. Patients receiving other investigational agents

  6. Patients who have had chemotherapy (for other malignancies) within 3 years prior toregistration

  7. Patients with any prior pelvic radiation therapy

  8. Prior malignancies requiring systemic therapy within the last 3 years (as priortherapy can increase toxicity of current chemo regimen, those patients should beexcluded).

  9. History of allergic reactions attributed to compound of similar chemical or biologiccomposition to the agents used in this study

  10. Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.

  11. Known HIV-positive patients on combination antiretroviral therapy are ineligiblebecause of the potential for pharmacokinetic interactions with chemotherapeuticdrugs. In addition, these patients are at increased risk of lethal infections whentreated with marrow-suppressive therapy.

  12. Pregnant or breast feeding.

Study Design

Total Participants: 19
Treatment Group(s): 1
Primary Treatment: FOLFOX regimen
Phase: 2
Study Start date:
May 11, 2018
Estimated Completion Date:
March 01, 2027

Connect with a study center

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

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