Cervical CancerPhase 2/3NCT01554397
Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer
A Phase 2/3 study testing PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT), Cisplatin and IMRT in people with Cervical Cancer, run by University of California, San Diego at 7 sites in 6 countries.
Trial summary
The purpose of this study is to find out whether patients with cervical cancer treated with PET-guided Bone Marrow Sparing IMRT have less side effects with equal cancer control compared to standard radiation techniques (IMRT). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT), Cisplatin and IMRT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 13 Oct 2011to 1 Jan 2022
- Phase
- Phase 2/3
- 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-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- Biopsy result positive for carcinoma within 60 days prior to registration
- FIGO clinical stage I-IVA disease, based on standard diagnostic workup, including:History/physical examination and/or Examination under anesthesia (if indicated)
- If the patient is status post hysterectomy, one or more of the following conditions must be present: positive lymph nodes, positive margins, parametrial invasion, or non-radical surgery (i.e., simple hysterectomy).
- If the patient is inoperable, one or more of the following conditions must be present: clinical stage IB2-IVA, positive lymph nodes on nodal sampling or frozen section, and/or parametrial invasion
- Within 42 days prior to registration, the patient must have any of the following, if clinically indicated: examination under anesthesia, cystoscopy, sigmoidoscopy, rigid proctoscopy, or colonoscopy.
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- X-ray (PA and lateral), CT scan, or PET/CT scan of the chest within 42 days prior to registration;
- CT scan, MRI, or PET/CT of the pelvis within 42 days prior to registration;
- Karnofsky Performance Status 60-100
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable); Creatinine clearance ≥ 50 mg/dl; Bilirubin < 1.5 mg/dl; WBC ≥ 3,000/μl; ALT/AST < 3 x ULN; INR ≤ 1.5
- Negative serum pregnancy test for women of child-bearing potential
Who cannot join
- Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years;
- Prior systemic chemotherapy within the past three years
- Prior radiotherapy to the pelvis or abdomen that would result in overlap of radiation therapy fields;
- Para-aortic, inguinal, or gross (unresected) pelvic nodal metastasis. Gross pelvic nodal metastasis is defined as either: Radiographic evidence of nodal metastasis on CT or MRI (node having short axis diameter > 1 cm)OR Radiographic evidence of nodal metastasis on diagnostic FDG-PET or PET/CT scan (abnormally increased FDG uptake as determined and documented by the radiologist)OR Biopsy-proven metastasis (e.g. needle biopsy) in undissected node
- Distant metastasis
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
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- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Uncontrolled diabetes, defined as diabetes mellitus, which in the opinion of any of the patient's physicians requires an immediate change in management;
- Uncompensated heart disease or uncontrolled high blood pressure
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
United States2 sites
Moores UC San Diego Cancer Center
La Jolla, California, 92093
University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: Phase II/III Clinical Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage I-IVA Cervical Carcinoma
The purpose of this study is to find out whether patients with cervical cancer treated with PET-guided Bone Marrow Sparing IMRT have less side effects with equal cancer control compared to standard radiation techniques (IMRT). The hypothesis is that PET-guided Bone Marrow Sparing IMRT will reduce acute hematologic and gastrointestinal toxicity and increase chemotherapy tolerance for cervical cancer patients treated with concurrent cisplatin.
Read the detailed description
Multiple randomized controlled trials have established concurrent cisplatin-based chemoradiotherapy as the standard of care for locally advanced cervical cancer [3-8]. The addition of concurrent cisplatin to radiotherapy (RT) increases pelvic control, disease-free survival (DFS) and overall survival; however, 5-year DFS and overall survival are still only approximately 60% and 5-year pelvic failure is approximately 30%. Moreover, acute gastrointestinal (GI) and hematologic toxicity are increased. Approximately 30% of patients will experience acute grade ≥ 3 toxicity, predominantly GI and hematologic. Methods to reduce toxicity during chemoradiotherapy, particularly gastrointestinal and hematologic, could mitigate this toxicity and take advantage of the therapeutic benefits of intensive concurrent chemotherapy.
Intensity modulated radiation therapy (IMRT) is a modern RT technique that differs from conventional techniques in many ways. First, patients undergo computed tomography (CT) simulation so that customized target volumes can be defined 3-dimensionally. IMRT treatment planning involves multiple beam angles and uses computerized inverse treatment planning optimization algorithms to identify dose distributions and intensity patterns that conform dose to the target, reducing radiation dose to surrounding tissues. IMRT delivery is typically accomplished with the use of multileaf collimators, which involve small motorized leaflets (collimators) that move in and out of the beam path, modulating the dose intensity.
PET-guided Bone Marrow Sparing IMRT is designed to spare hematopoietically active subregions of the pelvic bone marrow using quantitative image segmentation. Previous studies indicate this approach can reduce toxicity and improve chemotherapy tolerance, which may improve outcomes and help optimized delivery of cytotoxic chemotherapy.
- Conditions
- Cervical Cancer
- Being tested
- PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT), Cisplatin, IMRT
- Keywords
- Cervical, Carcinoma, Cisplatin, IMRT, Radiation, INTERTECC, International, External Beam, Brachytherapy, LDR, HDR, IGRT, CBCT
- Medical subject headings
- Uterine Cervical Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT)Radiation
Also called PET-guided Bone Marrow-Sparing IMRT
IMRT 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks with PET-guided Bone Marrow-Sparing
CisplatinDrug
Also called Platinol
Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks
IMRTRadiation
Also called Intensity Modulated Radiation Therapy
IMRT 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks
| Study group | Role | What they receive |
|---|---|---|
| IMRT with concurrent cisplatin 40 mg/m2 | Active comparator | Intensity-modulated Radiation Therapy (IMRT) with concurrent cisplatin 40 mg/m2 Receives: Drug: Cisplatin; Radiation: IMRT |
| PET-guided Bone Marrow-Sparing IMRT | Experimental | PET-guided Bone Marrow-Sparing IMRT with concurrent cisplatin 40 mg/m2 Receives: Radiation: PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT); Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Event (Acute Hematologic or GI Toxicity)
Acute grade >= 3 neutropenia or clinically significant >=2 diarrhea or any grade >=3 GI toxicity
Measured: Up to 30 days post radiation, about one month
Secondary outcomes (2)
Progression-free Survival
Time from registration to first recurrence of disease or death from any cause
Measured: Up to 36 Months post treatment, a total of about 38 months
Acute Adverse Events
Acute grade 2 and 3 Adverse Events occurring Up to 30 days post-treatment
Measured: Up to 30 days post-treatment, about one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study start13 Oct 2011
- Primary completion1 Jun 2021
- Study completion1 Jan 2022
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 Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase II: IMRT (standard) vs. PET-guided Bone Marrow-Sparing IMRT (experimental), non-randomized Phase III: IMRT (standard) vs. PET-guided Bone Marrow-Sparing IMRT (experimental), randomized
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Loren Mell, MD, University of California, San Diego
- Investigators
- Loren Mell, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554397
- Sponsor's protocol ID
- INTERTECC
- Other IDs
- R21CA162718-01
- Status last verified
- Nov 2024
- First submitted
- 8 Mar 2012
- Last updated
- 29 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II/III Clinical Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage I-IVA Cervical Carcinoma
- ClinicalTrials.gov ID
- NCT01554397
- Acronym / sponsor ID
- INTERTECC
- Conditions
- Cervical Cancer
- Keywords
- Cervical, Carcinoma, Cisplatin, IMRT, Radiation, INTERTECC, International, External Beam
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Oct 2011 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Posted 29 Nov 2024
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 find out whether patients with cervical cancer treated with PET-guided Bone Marrow Sparing IMRT have less side effects with equal cancer control compared to standard radiation techniques (IMRT). The hypothesis is that PET-guided Bone Marrow Sparing IMRT will reduce acute hematologic and gastrointestinal toxicity and increase chemotherapy tolerance for cervical cancer patients treated with concurrent cisplatin.
Detailed description
Multiple randomized controlled trials have established concurrent cisplatin-based chemoradiotherapy as the standard of care for locally advanced cervical cancer [3-8]. The addition of concurrent cisplatin to radiotherapy (RT) increases pelvic control, disease-free survival (DFS) and overall survival; however, 5-year DFS and overall survival are still only approximately 60% and 5-year pelvic failure is approximately 30%. Moreover, acute gastrointestinal (GI) and hematologic toxicity are increased. Approximately 30% of patients will experience acute grade ≥ 3 toxicity, predominantly GI and hematologic. Methods to reduce toxicity during chemoradiotherapy, particularly gastrointestinal and hematologic, could mitigate this toxicity and take advantage of the therapeutic benefits of intensive concurrent chemotherapy.
Intensity modulated radiation therapy (IMRT) is a modern RT technique that differs from conventional techniques in many ways. First, patients undergo computed tomography (CT) simulation so that customized target volumes can be defined 3-dimensionally. IMRT treatment planning involves multiple beam angles and uses computerized inverse treatment planning optimization algorithms to identify dose distributions and intensity patterns that conform dose to the target, reducing radiation dose to surrounding tissues. IMRT delivery is typically accomplished with the use of multileaf collimators, which involve small motorized leaflets (collimators) that move in and out of the beam path, modulating the dose intensity.
PET-guided Bone Marrow Sparing IMRT is designed to spare hematopoietically active subregions of the pelvic bone marrow using quantitative image segmentation. Previous studies indicate this approach can reduce toxicity and improve chemotherapy tolerance, which may improve outcomes and help optimized delivery of cytotoxic chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase II: IMRT (standard) vs. PET-guided Bone Marrow-Sparing IMRT (experimental), non-randomized Phase III: IMRT (standard) vs. PET-guided Bone Marrow-Sparing IMRT (experimental), randomized
| Arm | Type | Receives |
|---|---|---|
| IMRT with concurrent cisplatin 40 mg/m2 | Active comparator | Drug: Cisplatin, Radiation: IMRTIntensity-modulated Radiation Therapy (IMRT) with concurrent cisplatin 40 mg/m2 |
| PET-guided Bone Marrow-Sparing IMRT | Experimental | Radiation: PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT), Drug: CisplatinPET-guided Bone Marrow-Sparing IMRT with concurrent cisplatin 40 mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- Biopsy result positive for carcinoma within 60 days prior to registration
- FIGO clinical stage I-IVA disease, based on standard diagnostic workup, including:History/physical examination and/or Examination under anesthesia (if indicated)
- If the patient is status post hysterectomy, one or more of the following conditions must be present: positive lymph nodes, positive margins, parametrial invasion, or non-radical surgery (i.e., simple hysterectomy).
- If the patient is inoperable, one or more of the following conditions must be present: clinical stage IB2-IVA, positive lymph nodes on nodal sampling or frozen section, and/or parametrial invasion
Key exclusion criteria (10 listed)
- Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years;
- Prior systemic chemotherapy within the past three years
- Prior radiotherapy to the pelvis or abdomen that would result in overlap of radiation therapy fields;
- Para-aortic, inguinal, or gross (unresected) pelvic nodal metastasis. Gross pelvic nodal metastasis is defined as either: Radiographic evidence of nodal metastasis on CT or MRI (node having short axis diameter > 1 cm)OR Radiographic evidence of nodal metastasis on diagnostic FDG-PET or PET/CT scan (abnormally increased FDG uptake as determined and documented by the radiologist)OR Biopsy-proven metastasis (e.g. needle biopsy) in undissected node
- Distant metastasis
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 |
|---|---|---|
| PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT)Also: PET-guided Bone Marrow-Sparing IMRTIMRT 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks with PET-guided Bone Marrow-Sparing | Radiation | PET-guided Bone Marrow-Sparing IMRT |
| CisplatinAlso: PlatinolWeekly infusion of 40 mg/m2 (80 mg max) x 5 weeks | Drug | IMRT with concurrent cisplatin 40 mg/m2, PET-guided Bone Marrow-Sparing IMRT |
| IMRTAlso: Intensity Modulated Radiation TherapyIMRT 45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks | Radiation | IMRT with concurrent cisplatin 40 mg/m2 |
Primary outcome
Primary Event (Acute Hematologic or GI Toxicity)
Time frame: Up to 30 days post radiation, about one month
Acute grade >= 3 neutropenia or clinically significant >=2 diarrhea or any grade >=3 GI toxicity
2 secondary outcomes
Progression-free Survival
Time frame: Up to 36 Months post treatment, a total of about 38 months
Acute Adverse Events
Time frame: Up to 30 days post-treatment, about one month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- 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.
Loren Mell, MD principal investigator
University of California, San Diego
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT), Cisplatin and IMRT in people with Cervical Cancer, run by University of California, San Diego at 7 sites in 6 countries.
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 10 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 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, China, Czechia, India, Poland and 1 more country. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2024). 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?
Primary Event (Acute Hematologic or GI Toxicity) (time frame: Up to 30 days post radiation, about one month). 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 29 Nov 2024.