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

• Status: Withdrawn
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Capecitabine; Leucovorin; Oxaliplatin

Criteria

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 method

5. Pregnant or lactating women

6. 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

7. Presence of metastatic disease, including liver metastases

8. Laboratory values out of range