Esophageal Cancer Clinical Trial
Official title:
An Oxaliplatin-Based Phase II Randomized Study of Induction Chemotherapy Followed by Preoperative Chemoradiotherapy or Preoperative Chemoradiotherapy in Patients With Resectable Esophageal or Gastroesophageal Carcinoma
The goal of this clinical research study is to learn if a combination of the investigational
drug oxaliplatin with 5-Fluorouracil (5-FU) (given at the same time as radiation therapy) is
as effective as a combination of these two drugs given before and during radiation therapy
in the treatment of esophageal or gastroesophageal cancers. The safety of these combinations
of therapy will also be compared.
Objectives:
Primary objective:
Compare the Pathologic Complete Response rate and % of patients with <50% residual cancer in
the resected surgical specimen between Arms A and B.
Secondary objectives:
1. Compare 1-year and 3-year survival rates, median survival time, R0 resection rates,
safety, and local plus systemic relapse rates between Arms A and B
2. Perform exploratory correlative studies on blood, adjacent normal and cancer tissue to
assess predictive markers of response and outcome.
3. Evaluate the joint effects, including possible interactive effects, of
proton-versus-photon therapy and treatment arm on overall survival, R0 resection rates,
safety, and local plus systemic relapse rates.
Oxaliplatin and 5-FU are chemotherapy drugs that are commonly used to treat certain kinds of
cancers. 5-FU is designed to prevent cells from making DNA that is necessary for cell
growth. This disrupts the growth of the cancer cells, which causes the cancer cells to start
to die. Oxaliplatin is designed to damage DNA that is already formed.
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to one of two groups. Participants in the first group (Arm A)
will receive chemotherapy with radiation treatment. Participants in the second group (Arm B)
will receive chemotherapy first then chemotherapy with radiation treatment. The chemotherapy
that will be used in this study includes 5-FU and oxaliplatin. Arm B is 8 weeks longer than
Arm A. Your doctor will discuss with you whether you will receive proton or photon
radiation. If you receive proton radiation, it will be given in a building that is about a 5
minute drive from the main MD Anderson radiation clinic.
All participants will have had a routine upper gastrointestinal tract endoscopy and biopsy
with endoscopic ultrasound examination before receiving treatment on this study. However,
once you start on this study, the upper gastrointestinal tract endoscopy will be repeated
before the 2nd cycle of induction chemotherapy Arm B (if needed), before chemoradiation, and
before surgery. This procedure involves examination of the esophagus, stomach, and duodenum
by a flexible tube. Biopsies will be taken as necessary.
Arm A:
If you are assigned to Arm A, you will receive treatment with 5-FU over 24 hours for 5 days
each week for 5 weeks. It will be given as an infusion into a vein using a portable pump.
This will start on Day 1 (Monday) and will continue until Day 5 (Friday) of each
radiotherapy week for 5 weeks. You will need to carry this pump with you for about 96 hours.
The pump is about the size of a personal compact disc player. You will also receive
oxaliplatin as an infusion into a vein over 2 hours on Day 1. This will be repeated on Days
8, 15, 22, and 29. During this time you will receive radiation therapy every weekday for 5
weeks.
If the cancer gets worse or you experience intolerable side effects, you will be taken off
the study and your doctor will discuss other treatment options with you.
Each week while you are receiving chemoradiotherapy, around 1 tablespoon of blood will be
drawn for routine tests. Between 5-6 weeks after the completion of chemoradiotherapy, the
stage of the cancer will be evaluated. This includes drawing blood (about 1 tablespoon) for
routine tests, an Electrocardiography (ECG), a Physical Fitness Testing (PFT), a computed
tomography (CT) of the abdomen and chest (when necessary), a Positron emission tomography
(PET) or PET/CT scan, and an upper GI endoscopy with biopsies and checking the status of
your abdominal disease (if necessary).
When the evaluation of the status of your disease is complete, surgical removal of the
primary tumor and lymph nodes will be attempted. All participants with no spreading disease,
who are physically able to have surgery and have disease that is judged to be removable will
be eligible for surgery. The tube (J-tube) will be left in your body for at least 8 weeks
after the surgery to supplement your nutrition.
Arm B:
If you are assigned to Arm B, you will receive a starting (induction) course of chemotherapy
before radiation therapy ever starts. You will receive 5-FU over 48 hours as an infusion
into a vein using a portable pump. This will start on Day 1 and will continue over 48 hours.
This will be repeated on Day 15 for another 48 hours. You will need to carry this pump with
you at all times from Days 1-2 and Days 15-16. The pump is about the size of a personal
compact disc player. You will also receive oxaliplatin as an infusion into a vein over 2
hours on Days 1 and 15.
One cycle is equal to 28 days, which includes 2 doses of 5-FU and oxaliplatin given on Day 1
and Day 15. Treatment is always followed by 12 days of recovery. You will receive a maximum
of 2 cycles (4 doses of 5-FU and oxaliplatin).
After the first and second cycles, you will be given a full physical exam, upper GI x-rays
if necessary, about 1 tablespoon of blood will be drawn for routine blood tests, and if
needed, a CT scan of the abdomen and chest will be performed. You will have a PET scan or
PET CT scan and upper GI endoscopy with biopsy (if needed) before the start of Cycle 2 and
after the end of Cycle 2. If the disease has not gotten worse after the 1st cycle of
induction chemotherapy, you will receive the 2nd cycle. An upper gastrointestinal tract
endoscopy and biopsy will be performed. If the disease gets worse at any stage, you will go
straight to chemoradiotherapy. If the disease starts to spread, you will be taken off study
and your doctor will discuss other treatment options with you.
You will begin to receive chemoradiotherapy no more than 12 days after you complete the last
dose of induction chemotherapy. You will receive treatment with 5-FU over 24 hours for 5
days each week for 5 weeks. It will be given as an infusion into a vein using a portable
pump. This will start on Day 1 (Monday) and will continue until Day 5 (Friday) of each
radiotherapy week for 5 weeks. You will need to carry this pump with you at all times for
about 96 hours. You will also receive oxaliplatin as an infusion into a vein over 2 hours on
Day 1. This will be repeated on Days 8, 15, 22, and 29. During this time you will receive
radiation therapy every weekday for 5 weeks.
If the cancer gets worse or you experience intolerable side effects, you will be taken off
the study and your doctor will discuss other treatment options with you.
Each week while you are receiving chemoradiotherapy, around 1 tablespoon of blood will be
drawn for routine tests. Between 5-6 weeks after the completion of chemoradiotherapy, the
stage of the cancer will be evaluated. This includes drawing blood (about 1 tablespoon) for
routine tests, an ECG, a PFT, a CT of the abdomen and chest (when necessary), a PET Scan or
PET CT Scan, and an upper GI endoscopy with biopsies and checking the status of your
abdominal disease (if necessary).
When the evaluation of the status of your disease is complete, surgical removal of the
primary tumor and lymph nodes will be attempted. All participants with no spreading disease,
who are physically able to have surgery and have disease that is judged to be removable will
be eligible for surgery. The a tube (J-tube) will be left in your body for at least 8 weeks
after the surgery to supplement your nutrition.
Arms A and B:
You will be asked to fill out side effect sheets throughout your participation in this
research study. You will be asked questions regarding nausea, hair loss, fatigue, meals, and
other questions regarding your daily activities. You will be asked to keep a daily calendar
while receiving therapy of any type.
You will be asked to come for follow-up visits at MD Anderson at 3, 6, 9, and 12 months
after surgery and then every 6 months for 2 years, and then once a year for 2 years. At
these visits, you will have a full physical exam, and about 1 tablespoon of blood drawn for
routine tests and a CEA test (carcinoembryonic antigen - a protein made by cancer and normal
cells) if your CEA level was high in the past. You will also have a PET scan, PET CT scan,
or CT of the chest and abdomen. You will have an upper GI endoscopy with biopsies 3 months
after surgery and at other follow-up visits if needed. You may have a CT of the chest and
abdomen at the 3 month visit if needed.
This is an investigational study. Oxaliplatin is an investigational drug and is not approved
in the US for use in the treatment of esophageal and gastroesophageal cancer. The
combination of these 2 drugs (oxaliplatin + 5-FU) is investigational. All procedures are
standard of care. A total of up to 126 patients will take part in this study. All will be
enrolled at MD Anderson.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
Recruiting |
NCT05787522 -
Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
|
||
Not yet recruiting |
NCT05542680 -
Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer
|
N/A | |
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Completed |
NCT00003864 -
Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus
|
Phase 2 | |
Recruiting |
NCT05491616 -
Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study
|
Phase 2 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT00199849 -
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
|
Phase 1 | |
Completed |
NCT03756597 -
PAN-study: Pan-Cancer Early Detection Study (PAN)
|
||
Completed |
NCT00400114 -
Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer
|
Phase 2 | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Recruiting |
NCT04615806 -
The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy
|
N/A | |
Active, not recruiting |
NCT04566367 -
Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer
|
N/A | |
Active, not recruiting |
NCT03962179 -
Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)
|
N/A | |
Terminated |
NCT01446874 -
Prevention of Post-operative Pneumonia (POPP)
|
Phase 2/Phase 3 | |
Completed |
NCT03468634 -
Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy
|
N/A | |
Active, not recruiting |
NCT02869217 -
Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors
|
Phase 1 | |
Completed |
NCT02810652 -
Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
|
N/A | |
Recruiting |
NCT02544737 -
Apatinib for Metastatic Esophageal Cancer.
|
Phase 2 |