Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Stage II Rectal Cancer, Stage III Rectal Cancer

In brief

The primary objective of the pilot portion of this study is to establish the safety and tolerability of an extended treatment break period in patients who have undergone neoadjuvant chemoradiotherapy as well as use of systemic therapy during this break.

Key facts

Study ID

NCT01302613

Run by

University of Texas Southwestern Medical Center

People needed

0

Starts

2011-03-01

Expected to finish

2012-11-01

Last updated by the study team

2020-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed study-specific informed consent form
• Age > 18 years old
• Zubrod performance status 0-1
• Biopsy proven primary malignancy
• AJCC Stage II or III disease (T3-4 and/or N1-2 disease) as determined by endoscopic ultrasound and/or MRI staging
• Pretreatment rectal endoscopic ultrasound and pelvic MRI, colonoscopy, CT of chest, abdomen, and pelvis, and laboratory values as discussed below

You may not qualify if…

• History of inflammatory bowel disease
• Previous pelvic radiotherapy
• A major psychiatric illness which would limit understanding of the proposed protocol treatment and consent process.
• Men and women of reproductive potential must agree to use an effective contraception method
• Pregnant or lactating women
• Severe, active co-morbidity, defined as
• Unstable angina and/or CHF requiring hospitalization within the last six months
• Transmural myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Presence of metastatic disease, including liver metastases
• Laboratory values out of range

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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