Cervical CancerPhase 2NCT01019278
Proton Beam Radiation Therapy and Cisplatin in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer and Positive Lymph Nodes
A Phase 2 study testing proton beam radiation therapy, radiation therapy treatment planning/simulation and cisplatin in people with Cervical Cancer and Stage IB Cervical Cancer, run by Abramson Cancer Center at Penn Medicine.
Trial summary
RATIONALE: Specialized radiation therapy, such as proton beam radiotherapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Stage IB Cervical Cancer, Stage IIA Cervical Cancer
- What is being tested?
- proton beam radiation therapy, radiation therapy treatment planning/simulation and cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to 18 Aug 2011
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically documented carcinoma of the uterine cervix
- FIGO Stage IB to IVA
- Patients must have no distant metastases apart from positive lymph nodes by FDG PET
- Patients must have a Karnofsky Performance Status of >= 60
- Treatment plan includes cisplatin and patient has no medical contraindications to the administration of cisplatin
- Adequate bone marrow function: WBC >= 3000/mm^3; platelets >= 75,000 mm^3
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- Adequate renal function: creatinine =< 2.0 mg/dl (urinary diversion is permitted to improve renal function)
- Patients must have bilirubin =< 1.5 mg/dl
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- FDG PET Scan evidence of distant disease
- No prior surgery for treatment of disease other than exploratory laparotomy or biopsy will be allowed
- No previous systemic chemotherapy will be allowed
- No prior pelvic radiation therapy is permitted other than transvaginal irradiation to control bleeding will be allowed
- Women of childbearing potential who have a positive result on screening serum pregnancy test
About this study
Official title: A Feasibility and Phase II Study of Proton Beam Radiotherapy for Patients With Cervical Cancer and FDG-PET Positive Para-aortic Lymph Nodes
RATIONALE: Specialized radiation therapy, such as proton beam radiotherapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving proton beam radiation therapy together with cisplatin works in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer and positive lymph nodes.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of proton beam radiotherapy in patients with cervical cancer and FDG-positive para-aortic lymph nodes.
SECONDARY OBJECTIVES:
- To determine the incidence of acute toxicity of concurrent weekly cisplatin chemotherapy in addition to pelvic and para-aortic irradiation using proton radiotherapy with intracavitary brachytherapy in patients with carcinoma of the uterine cervix with pelvic and para-aortic nodal involvement as demonstrated by FDG-PET.
II. To assess late complications from irradiation using proton beam therapy in place of conventional photon beam therapy.
III. To compare the dose distribution to tumor and surrounding normal structures using DVHs (Dose Volume Histograms) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes.
IV. To evaluate whether there is a benefit to concurrent weekly cisplatin chemotherapy in addition to pelvic and para-aortic proton beam radiotherapy with intracavitary brachytherapy as evidenced by time to local failure, time to distant failure, time to other failures and overall survival in patients with carcinoma of the uterine cervix with pelvic and para-aortic nodal involvement as demonstrated by FDG-PET.
OUTLINE:
Patients undergo CT, MRI, or FDG-PET imaging scans for radiotherapy treatment planning. Patients then undergo external proton beam radiotherapy once daily, 5 times per week, for up to 9 weeks. Patients also receive cisplatin IV once weekly for 6 weeks during radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then annually for 3 years.
- Conditions
- Cervical Cancer, Stage IB Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage IVA Cervical Cancer
- Being tested
- proton beam radiation therapy, radiation therapy treatment planning/simulation, cisplatin
- 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.
proton beam radiation therapyRadiation
Undergo external proton beam radiation
radiation therapy treatment planning/simulationRadiation
cisplatinDrug
Also called CACP, CDDP, CPDD, DDP
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo external proton beam radiotherapy once daily, 5 times per week, for up to 9 weeks. Patients also receive cisplatin IV once weekly for 6 weeks during radiotherapy. Receives: Radiation: proton beam radiation therapy; Radiation: radiation therapy treatment planning/simulation; Drug: cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Acute toxicity, as assessed by NCI CTC Version 4.0
Measured: Within 60-90 days following completion of proton therapy
Secondary outcomes (2)
Late toxicity, as assessed by RTOG/EORTC late morbidity scoring system
Measured: More than 90 days after starting therapy
Clinical efficacy (time to local failure, time to distant failure, overall survival)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2011
- Study completion18 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lillie Lin, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019278
- Sponsor's protocol ID
- UPCC 22808
- Other IDs
- NCI-2009-01350
- Status last verified
- Sep 2016
- First submitted
- 18 Nov 2009
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Phase II Study of Proton Beam Radiotherapy for Patients With Cervical Cancer and FDG-PET Positive Para-aortic Lymph Nodes
- ClinicalTrials.gov ID
- NCT01019278
- Acronym / sponsor ID
- UPCC 22808
- Conditions
- Cervical Cancer, Stage IB Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage IVA Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- 18 Aug 2011
- First posted
- 24 Nov 2009 (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.
RATIONALE: Specialized radiation therapy, such as proton beam radiotherapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving proton beam radiation therapy together with cisplatin works in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer and positive lymph nodes.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of proton beam radiotherapy in patients with cervical cancer and FDG-positive para-aortic lymph nodes.
SECONDARY OBJECTIVES:
- To determine the incidence of acute toxicity of concurrent weekly cisplatin chemotherapy in addition to pelvic and para-aortic irradiation using proton radiotherapy with intracavitary brachytherapy in patients with carcinoma of the uterine cervix with pelvic and para-aortic nodal involvement as demonstrated by FDG-PET.
II. To assess late complications from irradiation using proton beam therapy in place of conventional photon beam therapy.
III. To compare the dose distribution to tumor and surrounding normal structures using DVHs (Dose Volume Histograms) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes.
IV. To evaluate whether there is a benefit to concurrent weekly cisplatin chemotherapy in addition to pelvic and para-aortic proton beam radiotherapy with intracavitary brachytherapy as evidenced by time to local failure, time to distant failure, time to other failures and overall survival in patients with carcinoma of the uterine cervix with pelvic and para-aortic nodal involvement as demonstrated by FDG-PET.
OUTLINE:
Patients undergo CT, MRI, or FDG-PET imaging scans for radiotherapy treatment planning. Patients then undergo external proton beam radiotherapy once daily, 5 times per week, for up to 9 weeks. Patients also receive cisplatin IV once weekly for 6 weeks during radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then annually for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Radiation: proton beam radiation therapy, Radiation: radiation therapy treatment planning/simulation, Drug: cisplatinPatients undergo external proton beam radiotherapy once daily, 5 times per week, for up to 9 weeks. Patients also receive cisplatin IV once weekly for 6 weeks during radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have histologically documented carcinoma of the uterine cervix
- FIGO Stage IB to IVA
- Patients must have no distant metastases apart from positive lymph nodes by FDG PET
- Patients must have a Karnofsky Performance Status of >= 60
- Treatment plan includes cisplatin and patient has no medical contraindications to the administration of cisplatin
Key exclusion criteria (5 listed)
- FDG PET Scan evidence of distant disease
- No prior surgery for treatment of disease other than exploratory laparotomy or biopsy will be allowed
- No previous systemic chemotherapy will be allowed
- No prior pelvic radiation therapy is permitted other than transvaginal irradiation to control bleeding will be allowed
- Women of childbearing potential who have a positive result on screening serum pregnancy test
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 |
|---|---|---|
| proton beam radiation therapyUndergo external proton beam radiation | Radiation | Arm I |
| radiation therapy treatment planning/simulation | Radiation | Arm I |
| cisplatinAlso: CACP, CDDP, CPDD, DDPGiven IV | Drug | Arm I |
Primary outcome
Feasibility
Acute toxicity, as assessed by NCI CTC Version 4.0
Time frame: Within 60-90 days following completion of proton therapy
2 secondary outcomes
Late toxicity, as assessed by RTOG/EORTC late morbidity scoring system
Time frame: More than 90 days after starting therapy
Clinical efficacy (time to local failure, time to distant failure, overall survival)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
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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.
Lillie Lin principal investigator
Abramson Cancer Center at Penn Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing proton beam radiation therapy, radiation therapy treatment planning/simulation and cisplatin in people with Cervical Cancer and Stage IB Cervical Cancer, run by Abramson Cancer Center at Penn Medicine.
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 9 inclusion and 5 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: withdrawn, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Feasibility. The study lists 2 primary outcomes in all. 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 3 Apr 2020.