Esophageal CancerPhase 1NCT01102088
Simultaneous Integrated Boost (SIB) in Esophageal Cancer
A Phase 1 study testing Radiation Therapy in people with Esophageal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to 8 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I/II Study of Evaluating the Safety and Efficacy of Using a Simultaneous Integrated Boost for Dose Escalation in Patients With Esophageal Cancer
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.
Read the detailed description
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 seen.
Chemotherapy Administration:
Your medical oncologist and or his/her team will review and discuss all aspects of chemotherapy administration including drugs you will receive, schedule of chemotherapy, and their side effects with you before starting treatment.
Your study doctor may adjust your chemotherapy dose if you experience intolerable side effects.
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 having.
- 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.
If the study doctor thinks it is needed, every year (+/- 2 months), the following tests and procedures will be performed to check the status of the disease:
- You will have a CT or PET/CT scan.
- You may have an upper endoscopy and tumor biopsy.
This is an investigational study. The chemotherapy agents 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 MD Anderson.
- Conditions
- Esophageal Cancer
- Being tested
- Radiation Therapy
- Keywords
- Cancer, Gastroesophageal, Simultaneous Integrated Boost, SIB, 5-Fluorouracil, 5-FU, Adrucil, Efudex, Docetaxel, Taxotere, Radiation, chemoradiation
- Medical subject headings
- Esophageal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 Weeks
Secondary outcomes (2)
Time to Local Failure
Local control assessed radiographically using either a PET or CT scan. The one-year local failure rate monitored using the methods of Thall et al.
Measured: 1 year
Pathologic Response
Complete pathologic response defined as no gross or microscopic tumor in the surgical specimen using light microscopy, but not immunohistochemical stains. Tissue from esophagogastroduodenoscopy can also be used. A partial pathologic response defined as shrinkage in tumor size compared with the original esophagogastroduodenoscopy.
Measured: 2 months after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startApr 2010
- Primary completion8 Jun 2019
- Study completion8 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Welsh, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102088
- Sponsor's protocol ID
- 2009-0847
- Other IDs
- NCI-2011-02030
- Status last verified
- May 2020
- First submitted
- 9 Apr 2010
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31529018
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Evaluating the Safety and Efficacy of Using a Simultaneous Integrated Boost for Dose Escalation in Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01102088
- Acronym / sponsor ID
- 2009-0847
- Conditions
- Esophageal Cancer
- Keywords
- Cancer, Gastroesophageal, Simultaneous Integrated Boost, SIB, 5-Fluorouracil, 5-FU, Adrucil, Efudex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- 8 Jun 2019 (actual)
- Study completion
- 8 Jun 2019 (actual)
- First posted
- 12 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 seen.
Chemotherapy Administration:
Your medical oncologist and or his/her team will review and discuss all aspects of chemotherapy administration including drugs you will receive, schedule of chemotherapy, and their side effects with you before starting treatment.
Your study doctor may adjust your chemotherapy dose if you experience intolerable side effects.
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 having.
- 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.
If the study doctor thinks it is needed, every year (+/- 2 months), the following tests and procedures will be performed to check the status of the disease:
- You will have a CT or PET/CT scan.
- You may have an upper endoscopy and tumor biopsy.
This is an investigational study. The chemotherapy agents 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 MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation + Chemotherapy | Experimental | Radiation: Radiation TherapySimultaneous 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapySimultaneous 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 | Radiation + Chemotherapy |
Primary outcome
Maximum Tolerated Dose (MTD) of Simultaneous Integrated Boost (SIB)
Time frame: 8 Weeks
MDT defined as CTCAE 3 grade 3 acute radiation toxicity of esophagitis 2 weeks after completion of 6 weeks of radiation therapy.
2 secondary outcomes
Time to Local Failure
Time frame: 1 year
Pathologic Response
Time frame: 2 months after radiation therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Derived from this study: PubMed 31529018Chen 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.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Welsh, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiation Therapy in people with Esophageal Cancer, run by M.D. Anderson Cancer Center 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 11 inclusion and 8 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: finished, as of the sponsor's last update on 22 May 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Simultaneous Integrated Boost (SIB) (time frame: 8 Weeks). 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 NCT01102088, which also lists 1 linked publication.
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 22 May 2020.