Cancer of the CervixIDEALNCT01627288
Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)
A study testing Boost radiation in people with Cancer of the Cervix and Cervical Neoplasms, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer of the Cervix, Cervical Neoplasms
- What is being tested?
- Boost radiation
- 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
- 4 Jun 2012to 16 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy confirmed malignancy of the gynecologic tract
- Involved pelvic or para-aortic lymph nodes
- Treatment plan to include delivery of concurrent chemoradiotherapy.
- Good performance status
- Negative pregnancy test in women of child-bearing potential
- Signed study-specific informed consent
- Lab results within study specific limits
Who cannot join
- Prior radiation to the abdomen or pelvis
- A history of Scleroderma or Inflammatory bowel disease
- Contraindication to chemotherapy or radiation
Trial locations and contacts
1 site in 1 country.
United States1 site
Radiation Oncology, DUMC
Durham, North Carolina, 27710
About this study
The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).
- Conditions
- Cancer of the Cervix, Cervical Neoplasms
- Being tested
- Boost radiation
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boost radiationRadiation
Many studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3). This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy
| Study group | Role | What they receive |
|---|---|---|
| Boost Radiation: Dose Level 1 | Experimental | 2.4 Gy X 25 fractions = 60 Gy Receives: Radiation: Boost radiation |
| Boost Radiation: Dose level 2 | Experimental | 2.6 Gy X 25 fractions = 65 Gy Receives: Radiation: Boost radiation |
| Boost Radiation: Dose level 3 | Experimental | 2.8 Gy x 25 fractions = 70 Gy Receives: Radiation: Boost radiation |
| Experimental: Boost Radiation Dose Level 0 | Experimental | If the 2 dose limiting toxicities are documented at dose level 1, therapy will be de-escalated to Dose level 0 defined below.
Dose level 0: 2.2 Gy X 25 fractions = 55 Gy Receives: Radiation: Boost radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).
Concurrent radiation therapy and chemotherapy is the standard of care for node positive cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into boosting gross disease in the pelvis or para-aortic region. This protocol is designed to determine the maximum tolerated dose of treating tumor bearing regions within the abdomen and pelvis, using an integrated boost technique and concurrent chemotherapy.
Measured: During RT to 6 weeks post RT
Secondary outcomes (6)
Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)
Local-regional control is defined as local control without any nodal recurrence.
Measured: 3 years following treatment
Time to Distant Recurrence (TTDR)
Measured: 3 years after treatment
Disease Free Survival (DFS)
Measured: 3 years after treatment
Overall Survival (OS)
Measured: 3 years after treatment
Number of Participants With Acute Dose Limiting Toxicities (DLT)
Acute DLT will be defined based on the side effects inherent from radiation therapy for gynecologic cancers, including effects on bowel, bladder, and skin.Since integrated radiation dose escalation is unlikely to substantially affect the hematopoietic system, only non-hematologic, grade 3-4, acute toxicity will be considered the primary dose-limiting toxicity (acute DLT). Dose limiting toxicity will include any of the following during treatment or within 6 weeks of completion: Acute Grade 3-4 enteritis or proctitis, Acute Grade 3-4 bladder toxicity, Acute Grade 4 dermatologic toxicity.
Measured: 6 weeks following treatment
Number of Participants With Late Dose Limiting Toxicities (DLT)
Late DLTs will be defined at grade 3-4 GI or GU toxicity with onset after 6 weeks of treatment.
Measured: 3 years following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study start4 Jun 2012
- Primary completion16 Nov 2018
- Study completion16 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer of the CervixStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junzo Chino, MD, Principal investigator, Duke Cancer Center/Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627288
- Sponsor's protocol ID
- Pro00033820
- Acronym
- IDEAL
- Status last verified
- Feb 2021
- First submitted
- 21 Jun 2012
- Last updated
- 8 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)
- ClinicalTrials.gov ID
- NCT01627288
- Acronym / sponsor ID
- IDEAL / Pro00033820
- Conditions
- Cancer of the Cervix, Cervical Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 4 Jun 2012 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 16 Nov 2019 (actual)
- First posted
- 25 Jun 2012 (estimated)
- Results
- Posted 10 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Boost Radiation: Dose Level 1 | Experimental | Radiation: Boost radiation2.4 Gy X 25 fractions = 60 Gy |
| Boost Radiation: Dose level 2 | Experimental | Radiation: Boost radiation2.6 Gy X 25 fractions = 65 Gy |
| Boost Radiation: Dose level 3 | Experimental | Radiation: Boost radiation2.8 Gy x 25 fractions = 70 Gy |
| Experimental: Boost Radiation Dose Level 0 | Experimental | Radiation: Boost radiationIf the 2 dose limiting toxicities are documented at dose level 1, therapy will be de-escalated to Dose level 0 defined below. Dose level 0: 2.2 Gy X 25 fractions = 55 Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Biopsy confirmed malignancy of the gynecologic tract
- Involved pelvic or para-aortic lymph nodes
- Treatment plan to include delivery of concurrent chemoradiotherapy.
- Good performance status
- Negative pregnancy test in women of child-bearing potential
Key exclusion criteria (3 listed)
- Prior radiation to the abdomen or pelvis
- A history of Scleroderma or Inflammatory bowel disease
- Contraindication to chemotherapy or radiation
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 |
|---|---|---|
| Boost radiationMany studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3). This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy | Radiation | Boost Radiation: Dose Level 1, Boost Radiation: Dose level 2, Boost Radiation: Dose level 3, Experimental: Boost Radiation Dose Level 0 |
Primary outcome
Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).
Time frame: During RT to 6 weeks post RT
Concurrent radiation therapy and chemotherapy is the standard of care for node positive cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into boosting gross disease in the pelvis or para-aortic region. This protocol is designed to determine the maximum tolerated dose of treating tumor bearing regions within the abdomen and pelvis, using an integrated boost technique and concurrent chemotherapy.
6 secondary outcomes
Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)
Time frame: 3 years following treatment
Time to Distant Recurrence (TTDR)
Time frame: 3 years after treatment
Disease Free Survival (DFS)
Time frame: 3 years after treatment
Overall Survival (OS)
Time frame: 3 years after treatment
Number of Participants With Acute Dose Limiting Toxicities (DLT)
Time frame: 6 weeks following treatment
Number of Participants With Late Dose Limiting Toxicities (DLT)
Time frame: 3 years following treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Junzo Chino, MD principal investigator
Duke Cancer Center/Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boost radiation in people with Cancer of the Cervix and Cervical Neoplasms, run by Duke University 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 7 inclusion and 3 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 8 Feb 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin). (time frame: During RT to 6 weeks post RT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2021.