Know Cancer

or
forgot password

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


Phase 2
18 Years
76 Years
Not Enrolling
Both
Esophageal Cancer, Gastroesophageal Cancer

Thank you

Trial Information

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


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.


Inclusion Criteria:



1. Local regional carcinoma of the thoracic esophagus (squamous cell or adeno) or
gastroesophageal junction.

2. Patients with T1N1, and T2-3 with any N (M1a only) will be eligible.

3. Normal liver (serum glutamic-pyruvic transaminase (SGPT) < 56µL, Total Bilirubin <1.5
mg/dL), kidney (Creatinine <1.75 mg/dL), and bone marrow functions (AGN >1,500µL,
platelet count >100,000/µL).

4. Performance status 0 or 1.

5. Signed informed consent by the investigator or their designee and patient.

6. Medically fit for surgery.

7. No Celiac (except for the GE junction cancers), supraclavicular, or paraaortic nodal
enlargement unless biopsy negative.

8. None of the celiac nodes should be larger than 2 cm

9. Male or Female but both sexes must practice adequate contraception while on therapy

10. >/=18 years but less than 76 years

11. No known allergy to any of the study drugs.

12. No prior therapy for this cancer.

13. No significant cancer (defined as non-melanomatous skin cancers and treated cervical
cancers) within the past 5 years

14. New York Heart Association (NYHA) I and II

Exclusion Criteria:

1. Patients with T1N0, T4, or M1b cancer will be excluded

2. Significant comorbid conditions (defined as uncontrolled diabetes, active angina or
heart failure, uncontrolled hypertension, or active psychiatric condition that
prevents consistent participation and compliance).

3. More than grade 1 neuropathy

4. Unable to comprehend the requirements of the study or comply with it.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Responses

Outcome Description:

Pathologic Complete Response rate (pathCR rate) Once surgery performed, response to therapy judged in surgical specimen with three possible categories 1) Pathologic complete response (no residual cancer in the specimen); 2) <50% of residual cells in the surgical specimen; or 3) >50% of cells in the surgical specimen.

Outcome Time Frame:

Surgery post chemotherapy (approximately 10-11 weeks)

Safety Issue:

No

Principal Investigator

Jaffer Ajani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2004-0703

NCT ID:

NCT00525915

Start Date:

April 2005

Completion Date:

March 2013

Related Keywords:

  • Esophageal Cancer
  • Gastroesophageal Cancer
  • Esophageal Cancer
  • Gastroesophageal Cancer
  • Gastroesophageal Junction
  • Radiation Therapy
  • 5-Fluorouracil
  • 5-FU
  • Adrucil
  • Efudex
  • Oxaliplatin
  • Carcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030