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Phase I Study of Evaluating the Safety of Using a Simultaneous Integrated Boost for Dose Escalation in Patients With Esophageal Cancer

Phase 1
18 Years
Open (Enrolling)
Esophageal Cancer

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Trial Information

Phase I Study of Evaluating the Safety of Using a Simultaneous Integrated Boost for Dose Escalation in Patients With Esophageal Cancer

The Study Drugs:

5-FU and its oral form capecitabine are designed to prevent cells from making DNA (the
genetic material of cells) that is necessary for cell growth. This disrupts the growth of
the cancer cells, which causes the cancer cells to start to die.

Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die.
It may also damage blood vessels in tumor tissue.

Radiation Therapy:

If you are found to be eligible, you will receive radiation therapy 5 days for 5 weeks. On
Week 6, you will receive radiation therapy on 3 days. You will be assigned to a dose level
of radiation based on when you join this study. Up to 2 dose levels of radiation will be
tested. The first group of participants will receive the lower dose level. The next group
will receive a higher dose than the group before it, if no intolerable side effects were

Chemotherapy Administration:

You will receive infusions of docetaxel and 5-FU during each radiation therapy week for 5

Chemotherapy will be given via a central line IV 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 placed
before you receive chemotherapy on this study and removed at the end of week 5.

You will receive docetaxel by vein over about 1 hour, 1 time a week (usually on Mondays) for
the first 5 weeks that you receive radiation.

You will receive 5-FU infusion by vein over 24 hours for 5 days each week (usually Monday-
Friday) for 5 weeks. This infusion will be given using a portable pump about the size of a
personal compact disk player. You will need to carry this portable pump with you for about
96 hours each week. The 5-FU infusion will be discontinued on the 5th day each week after
you have received your radiation treatment for the day.

If your cancer doctor decides that you can tolerate an form of 5-FU taken by mouth, you may
receive capecitabine in place of 5-FU given by vein. You will receive a prescription for
this chemotherapy drug from your cancer doctor before starting chemoradiation. You will be
instructed to take this drug twice a day ONLY on the days you receive radiation treatments
(usually Monday through Friday).

Your study doctor may adjust your chemotherapy dose if you experience intolerable side

Study Visits:

You will have weekly study visits while you are receiving radiation therapy. You may have an
extra study visit if your doctor thinks it is necessary. At each visit:

- Your complete medical history will be recorded.

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- You will be asked how you are feeling and about any side effects you may be having.

- Blood ( about 2-3 teaspoons) will be drawn for routine tests.

Length of Study:

You will receive radiation and chemotherapy for up to 6 weeks. You will be taken off study
if the disease gets worse or if you experience intolerable side effects.

Visit After the Last Dose:

You will have a study visit 2 weeks (+/- 5 days) after you stop receiving radiation. If you
are unable to return to MD Anderson, most of this may be done over the phone. At this visit:

- Your complete medical history will be updated.

- You will be asked how you are feeling and about any side effects that you may be

- If the doctor feels it is necessary you will have a physical exam, including
measurement of your weight, vital signs, and your performance status will be recorded.
If you are unable to travel to this visit, you will not have a physical exam.

Follow-Up Visits:

Your will have follow-up visits after 4 weeks from completing your radiation treatments.
Your doctor will decide when you are to return and which tests and procedures will be
performed. The following tests and procedures may be performed:

- Your complete medical history may be recorded.

- You may have a physical exam, including measurement of your weight and vital signs.

- You may have a CT or PET scan to check the status of the disease.

- You may be asked how you are feeling and about any side effects you may be having.

- You may have an upper GI endoscopy with biopsies.

This is an investigational study. Both docetaxel and 5-FU are FDA approved and are
commercially available for use in the treatment of esophageal cancer. The higher dose level
of radiation in this study is considered investigational.

Up to 42 patients will take part in this study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Histologically confirmed primary (non-recurrent) adenocarcinoma (AC) or squamous cell
carcinoma of the esophagus or AC of the gastroesophageal (GE) junction.

2. Age >/= 18.

3. Patients must be deemed unresectable disease or considered for a selective surgical
approach (where surgery is delay if a patient achieves a complete response) as
determined by the multidisciplinary evaluation or patient is not considered operable
due to medical reasons.

4. Patients with distant metastasis and life expectancy >/= 3 months are eligible.

5. ECOG Performance Status 0-2

6. No prior radiation to the thorax that would overlap with the current treatment field,
prior radiation to other areas is allowed.

7. Patients with nodal involvement are eligible

8. Adequate bone marrow, and renal functions as assessed by the following: Hemoglobin
>/= 9.0 g/dl, Platelet count >/= 100,000/mm^3, Creatinine
9. Ability to understand and the willingness to sign a written informed consent. A
signed informed consent must be obtained prior to any study specific procedures.

10. Patients (men and women) of childbearing potential must use effective method of birth
control throughout their participation in this study.

11. Induction chemotherapy is allowed.

Exclusion Criteria:

1. Patients with T1, N0 lesions.

2. Patients with a TE fistula or direct invasion into the mucosa of the trachea or major
bronchi. Bronchoscopy is encouraged if a TE fistula is suspected. The presence of a
fistula will exclude a patient from this study.

3. Prior surgery or radiotherapy for esophageal or gastroesophageal junction cancer.

4. Prior radiotherapy that would overlap the anticipated study treatment fields.

5. Patients with active second malignancy are allowed as long as it is determined that
the treatment of esophageal cancer is a higher priority through proper subspecialty

6. Uncontrolled concurrent illness including, but not limited to: serious uncontrolled
infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, or
psychiatric illness/social situations that would limit compliance with the study

7. Known hypersensitivity to docetaxel, 5-FU.

8. Any other condition or circumstance that would, in the opinion of the Investigator,
make the patient unsuitable for participation in the study.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Time Frame:

6 Weeks

Safety Issue:


Principal Investigator

James Welsh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2010

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Cancer
  • Gastroesophageal
  • Simultaneous Integrated Boost
  • SIB
  • 5-Fluorouracil
  • 5-FU
  • Adrucil
  • Efudex
  • Docetaxel
  • Taxotere
  • Radiation
  • chemoradiation
  • Esophageal Diseases
  • Esophageal Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030