Clinical trial · Interventional
Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma
A Pilot and Phase II Study of Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma
NCT01302613CI-TRIAL-00046728withdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Drug shortage
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| radiation | Radiation | — | UNRESOLVED |
| total mesorectal excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- arm one
- description
- RT + Chemo + surgery
- interventionNames
- Drug: Capecitabine
- Drug: 5-FU
- Drug: Leucovorin
- Drug: Oxaliplatin
- Radiation: radiation
- Procedure: total mesorectal excision
Primary outcomes (1)
- measure
- The primary study endpoint for the phase I portion of this study is to assess surgical complications through the Clavien grading system.
- timeFrame
- 90 days
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.