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A Pilot and Phase II Study of Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma

Phase 1/Phase 2
18 Years
Not Enrolling
Stage II Rectal Cancer, Stage III Rectal Cancer

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Trial Information

A Pilot and Phase II Study of Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma

The proposed protocol aims to continue tumor-directed therapy during the typical "break
period" in an effort to improve on both local tumor response as well as distant disease
control. First, the duration from completion of chemoradiotherapy would increase from 6-8
weeks to 9-11 weeks. As noted above, this may allow for further cell death with resultant
pathologic downstaging. Secondly, the protocol calls for continued systemic therapy during
the 9-11 week period, thus allowing continuation of therapies directed towards both the
primary as well as distant sites of disease. The primary aim of this pilot study would be
to establish the feasibility of this intensified neoadjuvant approach, especially with
respect to tolerability of the subsequent pelvic surgery. A subsequent phase II portion
will evaluate the efficacy of this treatment approach.

Inclusion Criteria:

1. Signed study-specific informed consent form

2. Age > 18 years old

3. Zubrod performance status 0-1

4. Biopsy proven primary malignancy

5. AJCC Stage II or III disease (T3-4 and/or N1-2 disease) as determined by endoscopic
ultrasound and/or MRI staging

6. Pretreatment rectal endoscopic ultrasound and pelvic MRI, colonoscopy, CT of chest,
abdomen, and pelvis, and laboratory values as discussed below

Exclusion Criteria:

1. History of inflammatory bowel disease

2. Previous pelvic radiotherapy

3. A major psychiatric illness which would limit understanding of the proposed protocol
treatment and consent process.

4. Men and women of reproductive potential must agree to use an effective contraception

5. Pregnant or lactating women

6. Severe, active co-morbidity, defined as

- Unstable angina and/or CHF requiring hospitalization within the last six

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of registration

7. Presence of metastatic disease, including liver metastases

8. Laboratory values out of range

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary study endpoint for the phase I portion of this study is to assess surgical complications through the Clavien grading system.

Outcome Description:

The adverse events will be followed prospectively from the date of surgery for 90 days. Dose-limiting toxicity (DLT) will be defined as > grade 3 anastomotic stricture or leak, infection (including pelvic abscess or wound infection), small bowel obstruction, or fistualization. Any other post-operative complication thought related directly to the surgical intervention that is a grade 3 or higher Clavien complication will also be considered dose-limiting toxicity.

Outcome Time Frame:

90 days

Safety Issue:


Principal Investigator

Jeffrey Meyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT Southwestern Medical Center Dallas


United States: Institutional Review Board

Study ID:

STU 082010-335



Start Date:

March 2011

Completion Date:

March 2016

Related Keywords:

  • Stage II Rectal Cancer
  • Stage III Rectal Cancer
  • rectal cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms



Ut Southwestern Medical CenterDallas, Texas  75390