NCT01102088

Brief Summary

The goal of this clinical research study is to find the highest tolerable dose of radiation that can be given in combination with chemotherapy in patients with esophageal cancer that cannot be removed by surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2010

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2019

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

9.2 years

First QC Date

April 9, 2010

Last Update Submit

May 20, 2020

Conditions

Esophageal Cancer

Keywords

CancerGastroesophagealSimultaneous Integrated BoostSIB5-Fluorouracil5-FUAdrucilEfudexDocetaxelTaxotereRadiationchemoradiation

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of Simultaneous Integrated Boost (SIB)

    MDT defined as CTCAE 3 grade 3 acute radiation toxicity of esophagitis 2 weeks after completion of 6 weeks of radiation therapy.

    8 Weeks

Secondary Outcomes (2)

  • Time to Local Failure

    1 year

  • Pathologic Response

    2 months after radiation therapy

Study Arms (1)

Radiation + Chemotherapy

EXPERIMENTAL

Simultaneous integrated boost (SIB) used in combination with a fixed dose of radiation (180 cGy in 28 fractions = 5040 Gy PTV dose). Two dose levels (210 cGy and 225 cGy each in 28 fractions) of SIB will be considered in the phase I part of the study, starting at 210 cGy in 28 daily fractions. For the phase II part of the study once the MTD has been achieved proton therapy will be allowed. Treatment dose will be identical to that of the photon treatment where the PTV is treated to 50.4 Gy(RBE) (RBE=1.1) while the CTV is boosted to 63 Gy(RBE) in 28 fractions. Chemotherapy Administration: Schedule of chemotherapy, and modifications of chemotherapy drugs during chemoradiation treatment will be at the discretion of the treating medical oncologist per their standard of practice and with consideration to standard chemotherapy drugs in the treatment of esophageal cancer.

Radiation: Radiation Therapy

Interventions

Radiation TherapyRADIATION

Simultaneous integrated boost (SIB) used in combination with a fixed dose of radiation (180 cGy in 28 fractions = 5040 Gy PTV dose). Two dose levels (210 cGy and 225 cGy each in 28 fractions) of SIB will be considered in the phase I part of the study, starting at 210 cGy in 28 daily fractions. For the phase II part of the study once the MTD has been achieved proton therapy will be allowed. Treatment dose will be identical to that of the photon treatment where the PTV is treated to 50.4 Gy(RBE) (RBE=1.1) while the CTV is boosted to 63 Gy(RBE) in 28 fractions.

Radiation + Chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed primary (non-recurrent) adenocarcinoma (AC) or squamous cell carcinoma of the esophagus or AC of the gastroesophageal (GE) junction.
  • Age \>/= 18.
  • 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.
  • Patients with distant metastasis and life expectancy \>/= 3 months are eligible.
  • ECOG Performance Status 0-2
  • No prior radiation to the thorax that would overlap with the current treatment field, prior radiation to other areas is allowed.
  • Patients with nodal involvement are eligible
  • Adequate bone marrow, and renal functions as assessed by the following: Hemoglobin \>/= 9.0 g/dl, Platelet count \>/= 100,000/mm\^3, Creatinine \</=1.5 times ULN
  • 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.
  • Patients (men and women) of childbearing potential must use effective method of birth control throughout their participation in this study.
  • Induction chemotherapy is allowed.

You may not qualify if:

  • Patients with T1, N0 lesions.
  • 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.
  • Prior surgery or radiotherapy for esophageal or gastroesophageal junction cancer.
  • Prior radiotherapy that would overlap the anticipated study treatment fields.
  • 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 consultations.
  • 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 requirements.
  • Known hypersensitivity to docetaxel, 5-FU.
  • Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Chen D, Menon H, Verma V, Seyedin SN, Ajani JA, Hofstetter WL, Nguyen QN, Chang JY, Gomez DR, Amini A, Swisher SG, Blum MA, Younes AI, Barsoumian HB, Erasmus JJ, Lee JH, Bhutani MS, Hess KR, Minsky BD, Welsh JW. Results of a Phase 1/2 Trial of Chemoradiotherapy With Simultaneous Integrated Boost of Radiotherapy Dose in Unresectable Locally Advanced Esophageal Cancer. JAMA Oncol. 2019 Nov 1;5(11):1597-1604. doi: 10.1001/jamaoncol.2019.2809.

    PMID: 31529018DERIVED

Related Links

MeSH Terms

Conditions

Esophageal NeoplasmsNeoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • James Welsh, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2010

First Posted

April 12, 2010

Study Start

April 1, 2010

Primary Completion

June 8, 2019

Study Completion

June 8, 2019

Last Updated

May 22, 2020

Record last verified: 2020-05

Locations

US(1)