A Phase 1/2 interventional study of Docetaxel and 5-FU in Esophageal Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-13.
Sponsored by M.D. Anderson Cancer Center · Phase 1/2, Interventional, and Treatment
The goal of this clinical research study is to learn if giving chemotherapy and radiation therapy before surgery for early-stage esophageal cancer can help to control the disease and if so, for how long. The safety of this treatment will also be studied.
The Study Treatment:
5-fluorouracil and docetaxel are designed to stop the growth of cancer cells, which may cause the cells to die. Docetaxel may also damage blood vessels in tumor tissue.
The radiation therapy in this study will be either intensity modulated radiation therapy (IMRT), which is a form of photon-based radiation therapy, or proton beam therapy (PBT). This will be up to your doctor. Both IMRT and PBT are designed to give radiation to the tumor area and limiting radiation exposure to nearby organs such as the lungs, heart, and spinal cord.
The surgery in this study removes part of the esophagus and nearby lymph nodes. The type of surgery will be the doctor's decision based on the location of the tumor in the esophagus. It will either be laparoscopic surgery (a minimally invasive procedure through small holes made in the abdomen) or open surgery (through the chest wall).
Study Treatment Administration:
If you are found to be eligible to take part in this study, you will receive radiation therapy and chemotherapy on the following schedule for up to 5 1/2 weeks. If there are holidays on the scheduled treatment days, the schedule may be slightly different and the study staff will discuss this with you.
Docetaxel will be given by vein over about 1 hour, 1 time a week (on Mondays).
5-fluorouracil will be given using a portable pump about the size of a personal CD player. You will need to carry this portable pump with you for about 96 hours each week.
Docetaxel will be given through a central venous catheter. A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure. The catheter will be removed at the end of Week 5.
Before every dose of docetaxel, you will receive dexamethasone to lower the risk of side effects. Dexamethasone will be given by vein over a few seconds.
Your doctor will let you know if and when you are eligible to have surgery. In this study, the surgery must be performed within 8-10 weeks after you finish chemotherapy and radiation therapy. You will be asked to sign a separate consent form that describes the surgery and anesthesia (numbing medicine) and their risks in more detail. The screening tests that will help your doctor decide if you are eligible to have surgery include the scans and endoscopy described below (4-6 weeks after radiation and chemotherapy).
You will no longer be able to receive radiation and chemotherapy if the disease gets worse or intolerable side effects occur. You will not be able to have surgery if the doctor decides surgery is not in your best interest (for example, if the disease or your general health gets worse).
Study Visits:
During Study Therapy:
Blood (about 3 tablespoons) will be drawn for routine tests during Week 3 of radiation and chemotherapy.
Follow-Up:
At 4-6 weeks after your last dose of radiation and chemotherapy, the following tests and procedures will be performed:
About 4 weeks after surgery, you will fill out 3 quality-of-life questionnaires. You will then fill out 2 quality-of-life questionnaires at 6 of your routine follow-up visits after surgery.
Every 3-6 months in the first 3 years after your last dose of radiation and chemotherapy, then every 6 months in the next 2 years, and every year after that from then on, the following tests and procedures will be performed:
Biomarker Testing:
If leftover tumor tissue is available from before you joined the study, the leftover tissue will be used for genetic biomarker testing. If you do not have leftover tumor tissue available from before you joined the study, leftover tissue from study procedures will be used for genetic biomarker testing.
This is an investigational study. Docetaxel and 5-fluorouracil are FDA approved and commercially available to treat esophageal cancer. However, it is investigational to give these drugs to patients with early-stage esophageal cancer.
It is investigational to give the combination of chemotherapy, radiation therapy, and surgery to patients with early-stage esophageal cancer.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's enrollment of 4 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Docetaxel 20 mg/m2 given by vein (IV) once a week up to 5 1/2 weeks. Dexamethasone 10 mg IV 30 minutes prior to weekly Docetaxel. 5-FU 300 mg/m2 IV, continuously for 96 hours 5 days a week for about 5 1/2 weeks. Radiation 50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks. Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
Drug: Docetaxel · Drug: 5-FU · Radiation: Radiotherapy · Procedure: Esophagectomy · Drug: Dexamethasone
20 mg/m2 given by vein (IV) over 1 hour once a week for up to 5 1/2 weeks.
Also known as: Taxotere
300 mg/m2 given by vein, continuously for 96 hours a week for about 5 1/2 weeks.
Also known as: Adrucil, Efudex, 5-Fluorouracil
50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks, Monday through Friday.
Also known as: Radiation Therapy
Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
Also known as: Surgical Resection
10 mg IV 30 minutes prior to weekly Docetaxel.
Also known as: Decadron
Pathologic Complete Response (PCR) Rate
The primary endpoint for this protocol is to assess the efficacy (pathologic complete response) and safety of Trimodality management (chemoradiotherapy followed by esophagectomy) in patients with clinically staged T1bN0M0 cancer of the esophagus or gastroesophageal junction. This is a single-arm phase IIB trial of chemo-radiation followed by surgery for patients with early stage grade T1b esophageal cancer. The rates of pathologic CR will be tabulated and their possible relationships to baseline covariates assessed by logistic regression. Unadjusted progression free survival time will be estimated by the method of Kaplan and Meier and its possible relationship to baseline covariates assessed by survival regression modeling.
Time frame: Pathologic Complete Response (PCR) will repeat EGD with biopsy to assess for clinical response to therapy after chemoradiation four to six weeks.
Disease-free Survival (DFS) Time
Disease-free survival (DFS) defined as the time to disease progression or death. DFS calculated from the time of surgery to disease progression or death. Followed for disease recurrence every 3-6 months in the first 3 years after last dose of radiation and chemotherapy, then every 6 months in the next 2 years, then every year.
Time frame: Time to disease progression or death, up to 6 years
| Milestone | Docetaxel + 5-FU + Radiation + Surgery |
|---|---|
| Started | 4 |
| Completed | 3 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
The primary endpoint for this protocol is to assess the efficacy (pathologic complete response) and safety of Trimodality management (chemoradiotherapy followed by esophagectomy) in patients with clinically staged T1bN0M0 cancer of the esophagus or gastroesophageal junction. This is a single-arm phase IIB trial of chemo-radiation followed by surgery for patients with early stage grade T1b esophageal cancer. The rates of pathologic CR will be tabulated and their possible relationships to baseline covariates assessed by logistic regression. Unadjusted progression free survival time will be estimated by the method of Kaplan and Meier and its possible relationship to baseline covariates assessed by survival regression modeling.
No measurements were reported for this outcome.
Disease-free survival (DFS) defined as the time to disease progression or death. DFS calculated from the time of surgery to disease progression or death. Followed for disease recurrence every 3-6 months in the first 3 years after last dose of radiation and chemotherapy, then every 6 months in the next 2 years, then every year.
No measurements were reported for this outcome.
Collected over From date of protocol registration until the date of documented development of adverse events (AEs) , assessed at the end of the 30-day period following surgery. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Docetaxel + 5-FU + Radiation + Surgery | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Event | Docetaxel + 5-FU + Radiation + Surgery |
|---|---|
| DysphagiaGastrointestinal disorders | 3/3 |
| FatigueGeneral disorders | 3/3 |
| OdynophagiaGastrointestinal disorders | 3/3 |
| DiarrheaGastrointestinal disorders | 2/3 |
| DyspepsiaGastrointestinal disorders | 2/3 |
| EsophagitisGastrointestinal disorders | 2/3 |
| AnorexiaMetabolism and nutrition disorders | 1/3 |
| ConstipationGastrointestinal disorders | 1/3 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/3 |
| DiaphoresisMetabolism and nutrition disorders | 1/3 |
3 out of 4 patients was were consented and treated under this protocol. 1 patients withdrew consent prior to protocol treatment.
| Age, Categorical(Participants) | Docetaxel + 5-FU + Radiation + Surgery |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 2 |
| Age, Continuous(years) | Docetaxel + 5-FU + Radiation + Surgery |
|---|---|
| Median | 67 (56 to 68) |
| Sex: Female, Male(Participants) | Docetaxel + 5-FU + Radiation + Surgery |
|---|---|
| Female | 0 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Docetaxel + 5-FU + Radiation + Surgery |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Docetaxel + 5-FU + Radiation + Surgery |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Docetaxel + 5-FU + Radiation + Surgery |
|---|---|
| United States | 3 |
| Karnofsky performance score (KPS)(Participants) | Docetaxel + 5-FU + Radiation + Surgery |
|---|---|
| KPS≥ 80 | 3 |
| KPS≥ 70 | 0 |
| Smoking(Participants) | Docetaxel + 5-FU + Radiation + Surgery |
|---|---|
| Never | 0 |
| Prior | 3 |
| Current | 0 |
3 further baseline measures are reported on the registry.
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center