AnemiaPhase 3NCT00017004

Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia

A Phase 3 study testing External Beam Radiation Therapy, Cisplatin and Internal Radiation Therapy in people with Anemia and Cervical Adenocarcinoma, run by Gynecologic Oncology Group at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production to treat anemia in patients who have received chemotherapy and/or radiation therapy for… Read more about this study

Who is it for?: Any age, women only
Conditions the study is for: Anemia, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma
What is being tested?: External Beam Radiation Therapy, Cisplatin and Internal Radiation Therapy
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 1 siteUnited States
Study dates: Aug 2001to 15 May 2004
Phase: Phase 3
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 Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
Stage IIB, IIIB, or IVA
Primary, previously untreated disease
Hemoglobin less than 14 g/dL at presentation
Negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT scan, MRI, or lymphadenectomy
Eligible for treatment with radical intent involving concurrent cisplatin and pelvic radiotherapy

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No involvement of the lower third of vagina
No carcinoma of the cervical stump
Performance status - GOG 0-3
See Disease Characteristics
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Bilirubin no greater than 1.5 times normal
SGOT no greater than 3 times normal
Alkaline phosphatase no greater than 3 times normal
Creatinine no greater than 2.0 mg/dL
No uncontrolled hypertension
No history of thrombotic vascular events (e.g., deep vein thrombosis or myocardial infarction)
No active hemolysis
No history of pulmonary embolism
No septicemia or severe infection
No circumstances that would preclude study participation
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
No history of hypersensitivity to epoetin alfa or human albumin
No diagnosis of vitamin B_12 or folic acid deficiency
No recent (within the past 3 months) or uncontrolled seizure disorder
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
See Disease Characteristics
See Disease Characteristics

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Gynecologic Oncology Group of Arizona
Phoenix, Arizona, 85012

Other trials in United States

About this study

Official title: Phase III Trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 g/l With Erythropoietin Versus Above 100 g/l Without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer

Read the detailed description

OBJECTIVES:

Assess the efficacy of raising and maintaining hemoglobin (Hgb) levels above 12.0 g/dL with epoetin alfa vs maintaining Hgb levels above 10.0 g/dL without epoetin alfa on progression-free survival, overall survival, and local control in anemic patients with cervical cancer receiving concurrent radiotherapy and cisplatin. Compare the quality of life of patients treated with these regimens.

OUTLINE:

This is a randomized study. Patients are stratified according to stage (IIB vs IIIB vs IVA), method of brachytherapy (low-dose vs high-dose), and surgical staging of para-aortic nodes (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo radiotherapy comprising pelvic external beam radiotherapy daily five days a week for 5 weeks, followed by either 1 or 2 implants of low-dose rate intracavitary brachytherapy or 5 fractions of high-dose rate intracavitary brachytherapy, followed by 3-5 days of parametrial boost radiotherapy. Patients receive cisplatin IV concurrently with pelvic external beam radiotherapy on days 1, 8, 15, 22, 29, and once during the week of parametrial boost radiotherapy.

Arm II: Patients undergo radiotherapy and chemotherapy as in arm I. Additionally, patients receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy and chemotherapy. Quality of life is assessed at baseline, during weeks 3 and 6, within 1 week of last brachytherapy, and every 3 months for 2 years. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 460 patients will be accrued for this study within 3.5 years.

Conditions: Anemia, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Drug Toxicity, Radiation Toxicity
Being tested: External Beam Radiation Therapy, Cisplatin, Internal Radiation Therapy, Epoetin Alfa
Medical subject headings: Anemia, Drug-Related Side Effects and Adverse Reactions, Radiation Injuries, Uterine Cervical Neoplasms

What participants receive

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

External Beam Radiation TherapyRadiation
Also called Definitive Radiation Therapy, EBRT, External Beam RT
Undergo radiation
CisplatinDrug
Given IV
Internal Radiation TherapyRadiation
Also called Brachytherapy, Internal Radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy
Undergo radiation
Epoetin AlfaBiological
Also called EPO, Epogen, Eprex, erythropoietin
Given SC

Study groups in NCT00017004
Study group	Role	What they receive
Arm I	Experimental	Patients undergo radiotherapy comprising pelvic external beam radiotherapy daily five days a week for 5 weeks, followed by either 1 or 2 implants of low-dose rate intracavitary brachytherapy or 5 fractions of high-dose rate intracavitary brachytherapy, followed by 3-5 days of parametrial boost radiotherapy. Patients receive cisplatin IV concurrently with pelvic external beam radiotherapy on days 1, 8, 15, 22, 29, and once during the week of parametrial boost radiotherapy. Receives: Radiation: External Beam Radiation Therapy; Drug: Cisplatin; Radiation: Internal Radiation Therapy
Arm II	Experimental	Patients undergo radiotherapy and chemotherapy as in arm I. Additionally, patients receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy and chemotherapy. Receives: Radiation: External Beam Radiation Therapy; Drug: Cisplatin; Radiation: Internal Radiation Therapy; Biological: Epoetin Alfa

What is being measured

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

Progression-free survival with progression defined as a 50% or greater increase in the cross-product of the existing primary tumor relative to the smallest cross-product from all previous exams
Measured: Up to 5 years

Secondary outcomes (2)

Overall survival
Measured: Up to 5 years
Local control, coded as successful if any relapse or disease progression is is contained within the pelvic field
Measured: Up to 5 years

Timeline

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

Aug 200115 May 2004

First posted27 Jan 2003 (estimated)
Study startAug 2001
Primary completion15 May 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnemiaStudies of the same condition, open and under way.
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 3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00017004
Sponsor's protocol ID: GOG-0191
Other IDs: NCI-2012-02384, CAN-NCIC-CX4, CDR0000068641, GOG-0191, GOG-0191, U10CA027469
Status last verified: Aug 2017
First submitted: 6 Jun 2001
Last updated: 9 Aug 2017
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
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A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
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RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome

All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III Trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 g/l With Erythropoietin Versus Above 100 g/l Without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer
ClinicalTrials.gov ID: NCT00017004
Acronym / sponsor ID: GOG-0191
Conditions: Anemia, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Drug Toxicity, Radiation Toxicity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Gynecologic Oncology GroupResearch network
Collaborators: Canadian Cancer Trials Group, National Cancer Institute (NCI)
Study start: Aug 2001
Primary completion: 15 May 2004 (actual)
First posted: 27 Jan 2003 (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.

Detailed description

OBJECTIVES:

OUTLINE:

PROJECTED ACCRUAL: A total of 460 patients will be accrued for this study within 3.5 years.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm I	Experimental	Radiation: External Beam Radiation Therapy, Drug: Cisplatin, Radiation: Internal Radiation TherapyPatients undergo radiotherapy comprising pelvic external beam radiotherapy daily five days a week for 5 weeks, followed by either 1 or 2 implants of low-dose rate intracavitary brachytherapy or 5 fractions of high-dose rate intracavitary brachytherapy, followed by 3-5 days of parametrial boost radiotherapy. Patients receive cisplatin IV concurrently with pelvic external beam radiotherapy on days 1, 8, 15, 22, 29, and once during the week of parametrial boost radiotherapy.
Arm II	Experimental	Radiation: External Beam Radiation Therapy, Drug: Cisplatin, Radiation: Internal Radiation Therapy, Biological: Epoetin AlfaPatients undergo radiotherapy and chemotherapy as in arm I. Additionally, patients receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy and chemotherapy.

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (31 listed)

Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
Hemoglobin less than 14 g/dL at presentation
Negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT scan, MRI, or lymphadenectomy
Eligible for treatment with radical intent involving concurrent cisplatin and pelvic radiotherapy
No involvement of the lower third of vagina

Key exclusion criteria (0 listed)

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
External Beam Radiation TherapyAlso: Definitive Radiation Therapy, EBRT, External Beam RTUndergo radiation	Radiation	Arm I, Arm II
CisplatinGiven IV	Drug	Arm I, Arm II
Internal Radiation TherapyAlso: Brachytherapy, Internal Radiation, Internal Radiation Brachytherapy, Radiation BrachytherapyUndergo radiation	Radiation	Arm I, Arm II
Epoetin AlfaAlso: EPO, Epogen, Eprex, erythropoietinGiven SC	Biological	Arm II

Primary outcome

Progression-free survival with progression defined as a 50% or greater increase in the cross-product of the existing primary tumor relative to the smallest cross-product from all previous exams
Time frame: Up to 5 years

2 secondary outcomes

Overall survival
Time frame: Up to 5 years
Local control, coded as successful if any relapse or disease progression is is contained within the pelvic field
Time frame: Up to 5 years

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 9 Aug 2017.

Related trials for Anemia

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
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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.

Gillian Thomas principal investigator

Gynecologic Oncology Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 31 inclusion and 0 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 9 Aug 2017. 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 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?

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?

Progression-free survival with progression defined as a 50% or greater increase in the cross-product of the existing primary tumor relative to the smallest cross-product from all previous exams (time frame: Up to 5 years). 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 NCT00017004.

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 9 Aug 2017.