Trial of Ultra-fractionated Adaptive Radiotherapy, Chemotherapy and Selective Omission of Surgery for Locally Advanced Rectal Cancer
Trial of Ultra-fractionated Adaptive Radiotherapy, Chemotherapy and Selective Omission of Surgery for Locally Advanced Rectal Cancer
The rationale of this clinical trial is to assess the feasibility of selective non-operative
 management for locally advanced rectal cancer using ultra-fractionated short course radiation
 therapy interdigitated with chemotherapy. We believe delivering short course radiotherapy
 over a prolonged interval, at escalated doses and with concurrent chemotherapy may be
 feasible and allow for improved clinical response.
Inclusion Criteria:

 1. At least 18 years of age. Both men and women and members of all races and ethnic
 groups will be included.

 2. Willing and able to provide written informed consent

 3. Pathologic diagnosis of rectal adenocarcinoma

 4. T3-4 and/or N+ disease

 5. No prior treatment for rectal adenocarcinoma

 6. Eastern Cooperative Group (ECOG) performance status of 0-2.

 7. Laboratory values supporting acceptable organ and marrow function within 30 days of
 eligibility confirmation. Defined as follows:

 -  WBC ≥ 3,000/mL;

 -  ANC WBC ≥ 1,500/mL;

 -  PLT ≥ 75,000/mL;

 -  T Bili ≤ 1.5 x upper limit of normal (ULN);

 -  AST/ALT ≤ 2.5 x ULN;

 -  Creatinine not above ULN, or creatinine clearance ≥60 mL/min/1.73 m2 for
 participants with creatinine levels above institutional normal.

 8. All men, as well as women of child-bearing potential must agree to use adequate
 contraception (hormonal or barrier method of birth control; abstinence) starting with
 the first dose of study therapy through 90 days after the last dose of study drugs.
 Should a woman become pregnant or suspect she is pregnant while participating in this
 study, she should inform her treating physician immediately.

 A female of child-bearing potential is any woman (regardless of sexual orientation, marital
 status, having undergone a tubal ligation, or remaining celibate by choice) who meets the
 following criteria:

 8.1 Has not undergone a hysterectomy or bilateral oophorectomy; or 8.2 Has not been
 naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any
 time in the preceding 12 consecutive months).

 Exclusion Criteria:

 1. Distant nodal disease (retroperitoneal nodes) including inguinal nodes, or any
 metastatic disease by CT or PET

 2. Prior RT to the pelvis.

 3. Uncontrolled comorbid illness or condition including an infection, congestive heart
 failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would limit
 compliance with the study requirements.

 4. Psychiatric illness/social situations that would limit consenting and compliance with
 study requirements.

 5. Participants who are pregnant or nursing due to the potential for congenital
 abnormalities and the potential of this regimen to harm nursing infants.