A Phase 2 interventional study of capecitabine and oxaliplatin in Colorectal Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 67 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin may make tumor cells more sensitive to radiation therapy. Giving capecitabine and oxaliplatin together with radiation therapy before surgery may shrink the tumor so it can be removed.
PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients who are undergoing surgery for stage I rectal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a non-randomized, multicenter study.
Patients undergo high-dose external beam radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oral capecitabine twice daily on days 1-14 and 22-35 and oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
Quality of life is assessed at baseline and then 1 year after surgery.
After completion of study treatment, patients are followed at 1 month, every 4 months for 3 years, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study within 2.8 years.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 90 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with the following conditions are NOT allowed on study:
Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
Drug: capecitabine · Drug: oxaliplatin · Procedure: neoadjuvant therapy · Radiation: radiation therapy
Also known as: Given IV
Given IV
Undergo surgery
Also known as: therapeutic conventional surgery
Undergo radiotherapy
Also known as: irradiation, radiotherapy, therapy, radiation
3-Year Disease-free Survival
The primary endpoint was 3-year disease-free survival (DFS). Evidence of local recurrence, distant metastasis, or death from any cause within 3 years counted as events in the time-to-event Kaplan-Meier analysis of disease-free survival.
Time frame: Up to 3 years
R0 Resection Rate (Negative Margin Rate)
The rate (percentage) of patients with negative resection margins after undergoing local excision is reported below.
Time frame: At time of surgery
Morbidity and Mortality Rate
Morbidity and mortality after neoadjuvant cheoradiotherapy and local excision.
Time frame: Up to 30 days
Rate of Pathologic Complete Response of the Primary Tumor
The rate (percentage) of patients with pathologic complete response (pCR) is reported below. Pathologic response will be determined by comparing tumor width and stage in the surgical specimen with the same parameters as determined by pre-CRT ERUS: PATHOLOGIC COMPLETE RESPONSE (pCR): no residual tumor.
Time frame: Up to 5 years
Local Recurrence Rate
The local recurrence rate (percentage) is defined as the percentage of patients who had local recurrence as initial sites of failure at the end of follow-up.
Time frame: Up to 5 years
| Milestone | Original Dose Group | Revised Dose Group |
|---|---|---|
| Started | 62 | 28 |
| Completed | 53 | 26 |
| Not completed | 9 | 2 |
| Withdrew: No consent | 2 | 0 |
| Withdrew: Qarc requirement not met | 1 | 0 |
| Withdrew: Suspected metastatic disease | 1 | 0 |
| Withdrew: No adenocarcinoma | 1 | 0 |
| Withdrew: Low creatinine clearance | 0 | 1 |
| Withdrew: Tumor size > 4cm | 1 | 0 |
| Withdrew: Tumor fixed on digital exam | 0 | 1 |
| Withdrew: No absolute neutrophil count | 2 | 0 |
| Withdrew: Biopsy done after registration | 1 | 0 |
The primary endpoint was 3-year disease-free survival (DFS). Evidence of local recurrence, distant metastasis, or death from any cause within 3 years counted as events in the time-to-event Kaplan-Meier analysis of disease-free survival.
| percentage of patients | Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery) |
|---|---|
| 3-Year Disease-free Survival | 88.2 (81.3 to 95.8) |
The rate (percentage) of patients with negative resection margins after undergoing local excision is reported below.
| percentage of patients | Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery) |
|---|---|
| R0 Resection Rate (Negative Margin Rate) | 98.7 |
Morbidity and mortality after neoadjuvant cheoradiotherapy and local excision.
| percentage of patients | Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery) |
|---|---|
| Mortality | 6 |
| Morbidity | 10 |
The rate (percentage) of patients with pathologic complete response (pCR) is reported below. Pathologic response will be determined by comparing tumor width and stage in the surgical specimen with the same parameters as determined by pre-CRT ERUS: PATHOLOGIC COMPLETE RESPONSE (pCR): no residual tumor.
| percentage of patients | Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery) |
|---|---|
| Rate of Pathologic Complete Response of the Primary Tumor | 44 (32 to 55) |
The local recurrence rate (percentage) is defined as the percentage of patients who had local recurrence as initial sites of failure at the end of follow-up.
| percentage of patients | Treatment (Capecitabine, Oxaliplatin, Radiotherapy, Surgery) |
|---|---|
| Local Recurrence Rate | 4 |
Collected over Up to 3 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Original Dose Group | 0/57 (0%) | 6/57 (10.5%) | 32/57 (56.1%) |
| Revised Dose Group | 0/27 (0%) | 2/27 (7.4%) | 25/27 (92.6%) |
| Event | Original Dose Group | Revised Dose Group |
|---|---|---|
| Hemoglobin decreasedBlood and lymphatic system disorders | 0/57 | 1/27 |
| Serum phosphate decreasedMetabolism and nutrition disorders | 0/57 | 1/27 |
| Myocardial ischemiaCardiac disorders | 1/57 | 0/27 |
| PainGeneral disorders | 1/57 | 0/27 |
| AppendicitisInfections and infestations | 1/57 | 0/27 |
| Lymphocyte count decreasedInvestigations | 1/57 | 0/27 |
| DehydrationMetabolism and nutrition disorders | 1/57 | 0/27 |
| Serum potassium decreasedMetabolism and nutrition disorders | 1/57 | 0/27 |
| HematomaVascular disorders | 1/57 | 0/27 |
| Event | Original Dose Group | Revised Dose Group |
|---|---|---|
| DiarrheaGastrointestinal disorders | 20/57 | 21/27 |
| FatigueGeneral disorders | 7/57 | 18/27 |
| NauseaGastrointestinal disorders | 8/57 | 15/27 |
| Hemoglobin decreasedBlood and lymphatic system disorders | 3/57 | 13/27 |
| Rectal painGastrointestinal disorders | 6/57 | 13/27 |
| AnorexiaMetabolism and nutrition disorders | 3/57 | 10/27 |
| ConstipationGastrointestinal disorders | 0/57 | 9/27 |
| Lymphocyte count decreasedInvestigations | 2/57 | 9/27 |
| Blood glucose increasedMetabolism and nutrition disorders | 3/57 | 9/27 |
| Urinary frequencyRenal and urinary disorders | 0/57 | 9/27 |
| Age, Continuous(years) | Original Dose Group | Revised Dose Group | Total |
|---|---|---|---|
| Median | 62 (30 to 80) | 63 (45 to 83) | 62 (30 to 83) |
| Sex: Female, Male(Participants) | Original Dose Group | Revised Dose Group | Total |
|---|---|---|---|
| Female | 20 | 6 | 26 |
| Male | 33 | 20 | 53 |
| Region of Enrollment(Participants) | Original Dose Group | Revised Dose Group | Total |
|---|---|---|---|
| United States | 53 | 26 | 79 |
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology