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Preservation of Organs in Participants with Early Rectal Cancer

Trial Status: Active

This phase II trial studies preservation of organs in patients with early rectal cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and calcium fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading. Giving more than one drug (combination chemotherapy), and giving them after local excision may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

Inclusion Criteria

  • Histologically proven adenocarcinoma of the lower rectum (lower border =< 6 cm from anal verge as assessed by pelvic magnetic resonance imaging [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, computed tomography (CT) chest/abdomen/pelvis or positron-emission tomography (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.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Leukocytes >= 3,000/mcL.
  • Absolute neutrophil count >= 1,500/mcL.
  • Platelets >= 100,000/mcL.
  • Total bilirubin =< 1.5 times upper limit of normal (ULN).
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) (serum glutamic oxaloacetic transaminase [SGOT]/serum glutamic pyruvic transaminase [SGPT]) =< 3 times institutional normal limits.
  • Creatinine < 1.5 times ULN.
  • Creatinine clearance >= 60 Ml/min/1.73 m^2 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 leucovorin calcium (calcium folinate), 5-fluorouracil, and oxaliplatin (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 > 5 mm, prediction of positive circumferential resection margin, are also excluded.
  • T4, node positive or advanced rectal adenocarcinoma. Node positivity defined as nodes greater than 1 cm 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 human immunodeficiency virus (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.


Fox Chase Cancer Center
Status: ACTIVE
Contact: Namrata (Neena) Vijayvergia
Phone: 215-214-4283
Temple University Hospital
Status: ACTIVE
Contact: Matthew Miller Philp


I. To determine feasibility of performing successful local excision (negative margins).


I. To assess bowel function in patients treated with organ preserving approach for early stage low rectal cancer before and after therapy.

II. To assess sexual function separately within men and women treated with organ preserving approach for early stage low rectal cancer before and after therapy.

III. To assess health-related quality of life in patients treated with organ preserving approach for early stage low rectal cancer before and after therapy.


NEOADJUVANT CHEMOTHERAPY: Patients receive oxaliplatin intravenously (IV) over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 5-15 minutes on day 1 and continuously over 46-48 hours on days 1 and 2. Treatment repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

SURGERY: Beginning 6-12 weeks after neoadjuvant chemotherapy, patients may undergo local excision of tumor.

POST-OPERATIVE CHEMRADIATION THERAPY: Beginning 4-12 weeks after surgery, patients receive fluorouracil IV continuously 5 days a week or capecitabine orally (PO) twice daily (BID) 5 days a week. Patients also undergo radiation therapy in 30 fractions 5 days per week. Treatment repeats for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months 3 years and then every 6 months for 2 years.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Fox Chase Cancer Center

Principal Investigator
Namrata (Neena) Vijayvergia

  • Primary ID 18-1013
  • Secondary IDs NCI-2018-01470, GI-116
  • ID NCT03548961