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Esophagus CancerPhase 1NCT04046575

Radiation Dose Intensification With Accelerated Hypofractionated Intensity Modulated Radiation Therapy and Concurrent Carboplatin and Paclitaxel for Inoperable Esophageal Cancer

A Phase 1 study testing Intensity Modulated Radiation Therapy, Carboplatin and MD Anderson Symptom Inventory (MDASI)-Plus module in people with Esophagus Cancer and Esophageal Cancer, run by Washington University School of Medicine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Rates of local disease control in patients with locally advanced esophageal cancer who are not candidates for surgical resection are suboptimal. Despite treatment with chemotherapy and radiation therapy approximately half of patients will develop recurrence of their cancer at the site of the original primary cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intensity Modulated Radiation Therapy, Carboplatin and MD Anderson Symptom Inventory (MDASI)-Plus module
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
7 Nov 2019to 20 Nov 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biopsy-proven carcinoma of the thoracic esophagus, or gastroesophageal junction (GEJ).
  • Amenable to definitive chemoradiation.
  • Unresectable esophageal cancer or not a surgical candidate as determined by a surgeon or multidisciplinary tumor board.
  • At least 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Complete blood count (CBC) with differential obtained within 30 days prior to registration with adequate bone marrow function:
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  • Absolute neutrophil count (ANC) ≥1,500 cells/mm3
  • Platelets ≥100,000 cells/ mm3
  • Hemoglobin ≥9 g/dL (transfusion or other intervention to achieve hemoglobin ≥9 g/dL is acceptable).
  • Adequate renal function within 30 days prior to registration: Serum creatinine ≤ 1.5x upper limit of normal or calculated creatinine clearance ≥ 50 mL/min within 30 days prior to registration estimated by the Cockcroft-Gault formula:
  • Creatinine Clearance (male) = [(140 - age) x (wt in kg)] [(Serum Creatinine mg/dl) x (72)] Creatinine Clearance (female) = 0.85 x Creatinine Clearance (male)
  • Adequate hepatic function within 30 days prior to registration: bilirubin ≤ 1.5x upper limit of normal, ALT/AST ≤3 x upper limit of normal (ULN).
  • Negative pregnancy test within 14 days of registration or otherwise be determined to not be of childbearing potential. Postmenopausal women must be amenorrheic for 12 months or more. Women of childbearing potential must agree to perform appropriate contraception methods and not breastfeed until 30 days after last chemotherapy.
  • Planned to undergo IMRT with photon beam radiation therapy. 3D CRT and proton modalities are not allowed.
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Who cannot join

  • Primary cervical esophageal cancer
  • Siewert-Stein Type III carcinomas of the stomach.
  • Esophageal perforation, fistula, or deep ulceration to the mediastinum.
  • Currently receiving any other investigational agents.
  • Known brain metastases. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel, or other agents used in the study.
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  • Planning to undergo or has already undergone induction chemotherapy.
  • Presence of any active malignancy within 2 years that may alter the course of esophageal cancer therapy.
  • Prior radiation therapy to the neck, thorax, or abdomen is not allowed UNLESS there is expected to be no overlap with the study esophageal radiotherapy treatment. Prior radiation therapy treatment plan reports must be reviewed by study PI to verify no overlap of treatment fields.
  • Severe active comorbidity as defined below:
  • Unstable angina and/or congestive heart failure within the last 6 months.
  • Transmural myocardial infarction within the last 6 months.
  • History of stroke, cerebral vascular accident, or transient ischemic attack within the last 6 months.
  • Serious and inadequately controlled cardiac arrhythmia
  • Bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
  • Peripheral neuropathy > grade 1 at time of registration.
  • Persistent complications from any major surgery within 4 weeks of study treatment start.
  • Any other major medical illness that in the investigator's opinion would prevent safe administration or completion of protocol therapy.
  • Pregnant or lactating woman. Women of childbearing potential with positive pregnancy test at baseline, or women who have not taken a pregnancy test at baseline. A man or woman who does not agree to use appropriate contraception.
  • Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Phase I Study of Radiation Dose Intensification With Accelerated Hypofractionated Intensity Modulated Radiation Therapy and Concurrent Carboplatin and Paclitaxel for Inoperable Esophageal Cancer

Rates of local disease control in patients with locally advanced esophageal cancer who are not candidates for surgical resection are suboptimal. Despite treatment with chemotherapy and radiation therapy approximately half of patients will develop recurrence of their cancer at the site of the original primary cancer. Salvage therapy options are largely ineffective and nearly all patients who develop local disease recurrence will succumb to their cancer. Recent clinical trials for lung cancer have demonstrated that local tumor control can be improved safely with accelerated hypofractionated radiation therapy regimens in order to achieve radiation dose intensification. This clinical trial aims to adapt those techniques and assess the safety of such a regimen for the treatment of inoperable thoracic esophageal cancers.

Being tested
Intensity Modulated Radiation Therapy, Carboplatin, MD Anderson Symptom Inventory (MDASI)-Plus module, EuroQol (EQ-5D), SF-12
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensity Modulated Radiation TherapyRadiation

    Also called IMRT

    -15 fractions of treatment

  • CarboplatinDrug

    Also called Paraplatin

    Begins on day 1 of radiotherapy

  • MD Anderson Symptom Inventory (MDASI)-Plus moduleOther

    The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT

  • EuroQol (EQ-5D)Other

    The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT

  • SF-12Other

    The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT

  • MOS Social Support MeasureOther

    The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT

  • CES-DOther

    The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT

  • Blood for ctDNA (optional)Procedure or surgery

    -Collected at pre-treatment, every 2 weeks during chemoradiation, every 2-3 weeks during consolidation chemotherapy, completion of therapy, 6-8 week follow-up, 3 month follow-up, 6 month follow-up, and 12 month follow-up

  • Blood for SCCAProcedure or surgery

    -Collected at pre-treatment, completion of therapy, and 6 month follow-up

  • PaclitaxelDrug

    Also called Taxol

    Begins on day 1 of radiotherapy

Study groups in NCT04046575
Study groupRoleWhat they receive
IMRT + Carboplatin + PaclitaxelExperimentalConcurrent chemoradiation will consist of hypofractionated intensity modulated radiation therapy (IMRT) with simultaneous integrated boost (SIB) for 3 weeks with carboplatin and paclitaxel for 3 cycles every 7 days. Endoscopy and (optional) PET/CT within 6-8 weeks post-completion of chemoradiation.
Receives: Radiation: Intensity Modulated Radiation Therapy; Drug: Carboplatin; Other: MD Anderson Symptom Inventory (MDASI)-Plus module; Other: EuroQol (EQ-5D); Other: SF-12; Other: MOS Social Support Measure; Other: CES-D; Procedure: Blood for ctDNA (optional); Procedure: Blood for SCCA; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) of hypofractionated IMRT with chemotherapy

    The MTD of the combination of radiation and FOLFOX will be estimated using the proposed TITE-CRM model. After the phase I study, the MTD will be chosen as the dose that yields a posterior toxicity estimate closest to 20% while being between 15% and 25%. Toxicity will be coded using CTCAE v5.0.

    Measured: Through 6 month follow-up for all enrolled patients (estimated to be 65 months)

Secondary outcomes (9)

  1. Median local relapse-free survival

    -The length of time after treatment ends that the participants survives without any signs or symptoms of the cancer recurring within the radiated field

    Measured: Through completion of follow-up (up to 6 years)

  2. Median overall survival

    -The length of time from the start of treatment that participants are still alive

    Measured: Through completion of follow-up (up to 6 years)

  3. Median progression-free survival

    -The length of time from the start of treatment to progression or death from any cause

    Measured: Through completion of follow-up (up to 6 years)

  4. Patient reported outcomes as measured by the MDASI-Plus

    • The MDASI-plus is a reliable, validated tool for assessing cancer-related symptoms regardless of therapy or specific cancer diagnosis. Patients are asked to fill out a twenty-seven question inventory, ranking their symptoms on a 0 (no problems) to 10 (worst imaginable) scale
    • The mean of the scores will be calculated at each time point and compared to other time points to assess changes in cancer-related symptoms

    Measured: From baseline through 12 months post end of treatment

  5. Patient reported outcomes as measured by the EQ-5D

    • standardized 2-part, patient-administered instrument used for direct and indirect assessment of health state utilities
    • The first part asks respondents to "check the ONE box [next to the appropriate statement] that best describes your health TODAY" for each of 5 health dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state
    • Both the 5-item index score and the VAS score are transformed into a utility score between 0 "Worst health state" and 1 "Best health state

    Measured: From baseline through 12 months post end of treatment

  6. Patient reported outcomes as measured by the SF-12

    • 12-item questionnaire measuring physical and mental functional status
    • Mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life

    Measured: From baseline through 12 months post end of treatment

  7. Patient reported outcomes as measured by the MOS Social Support

    -19 items

    -. Response choices range from "none of the time" (1) to "all of the time" (5). A mean social support score for all 19 items is computed with higher scores indicating a greater availability of social support.

    Measured: From baseline through 12 months post end of treatment

  8. Patient reported outcomes as measured by the 4-Item CES-D

    • 4 item screening version to evaluate depressive symptoms
    • The mean of the scores will be calculated at each time point and compared to other time points to assess changes in depression symptoms

    Measured: From baseline through 12 months post end of treatment

  9. Number and type of adverse events experienced by patient

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2019
  2. Study start7 Nov 2019
  3. Primary completion2 Jun 2025
  4. Study completion20 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04046575
Sponsor's protocol ID
201909019
Status last verified
Jul 2026
First submitted
2 Aug 2019
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Intensity Modulated Radiation Therapy, Carboplatin and MD Anderson Symptom Inventory (MDASI)-Plus module in people with Esophagus Cancer and Esophageal Cancer, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of hypofractionated IMRT with chemotherapy (time frame: Through 6 month follow-up for all enrolled patients (estimated to be 65 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04046575.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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