NCT01101451|CompletedPhase 3ResultsDMC

Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery

Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy (NCT #01101451)

GOG Foundation ClinicalTrials.gov

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2 other identifiers

GOG-0263NCI-2011-02037

Study Type

interventional

Target

340

Locations

3 countries

Sites

719

Timeline

RegisteredApr 2010

StartedApr 2010

CompletionApr 2024

Brief Summary

This randomized phase III trial studies radiation therapy with chemotherapy to see how well they work compared to radiation therapy alone in treating patients with stage I-IIA cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

340

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Apr 2010

Longer than P75 for phase_3

Geographic Reach

3 countries

719 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

14 years study duration

First Submitted

Initial submission to the registry

April 9, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2010

Completed

Same day until next milestone

Study Start

First participant enrolled

April 12, 2010

Completed

13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2024

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

May 1, 2025

Completed

Last Updated

May 23, 2025

Status Verified

October 1, 2024

Enrollment Period

13.8 years

First QC Date

April 9, 2010

Results QC Date

October 28, 2024

Last Update Submit

May 21, 2025

Conditions

Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Stage I Cervical Cancer AJCC v6 and v7 Stage IA Cervical Cancer AJCC v6 and v7 Stage IB Cervical Cancer AJCC v6 and v7 Stage IIA Cervical Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

Recurrence-free Survival (RFS) Rate at 3-years
Estimate for probability of RFS at 3 years using Kaplan-Meier method, where RFS is defined as time from protocol registration (and randomization) to the date of first documented recurrence, death, or the date of last contact, whichever occurs first. Patients without recurrence or death were censored at the date of last contact.
3 years from randomization

Secondary Outcomes (4)

Overall Survival (OS) Rate at 3-years
3 years from randomization
Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period.
During treatment period and up to 21 days after stopping the study treatment. The median treatment duration was 39 days.
Patient Risk-benefit
up to 11 years
Quality of Life (QOL) as Measured With the FACT-Cx TOI
1. Pre-treatment (baseline), 2. 3 weeks following the first day of treatment, 3. 7 weeks following the first day of treatment, 4. 36 weeks following the first day of treatment.

Other Outcomes (3)

Treatment Compliance
Up to 11 years
Site(s) of Recurrence
Up to 11 years
Local Control
Up to 11 years

Study Arms (2)

Arm I (EBRT, IMRT)

ACTIVE COMPARATOR

Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5.5 weeks.

Radiation: External Beam Radiation TherapyRadiation: Intensity-Modulated Radiation TherapyOther: Laboratory Biomarker AnalysisOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm II (cisplatin, EBRT, IMRT)

EXPERIMENTAL

Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: CisplatinRadiation: External Beam Radiation TherapyRadiation: Intensity-Modulated Radiation TherapyOther: Laboratory Biomarker AnalysisOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

CisplatinDRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone''s Chloride, Peyrone''s Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Arm II (cisplatin, EBRT, IMRT)

External Beam Radiation TherapyRADIATION

Undergo radiotherapy

Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam

Arm I (EBRT, IMRT)Arm II (cisplatin, EBRT, IMRT)

Intensity-Modulated Radiation TherapyRADIATION

Undergo radiotherapy

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

Arm I (EBRT, IMRT)Arm II (cisplatin, EBRT, IMRT)

Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm I (EBRT, IMRT)Arm II (cisplatin, EBRT, IMRT)

Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (EBRT, IMRT)Arm II (cisplatin, EBRT, IMRT)

Questionnaire AdministrationOTHER

Ancillary studies

Arm I (EBRT, IMRT)Arm II (cisplatin, EBRT, IMRT)

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy
Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed):
Positive capillary-lymphovascular space involvement and one of the following:
Deep third penetration
Middle third penetration, clinical tumor \>= 2 cm
Superficial third penetration, clinical tumor \>= 5 cm
Negative capillary-lymphatic space involvement
Middle or deep third penetration, clinical tumor \>= 4 cm
Absolute neutrophil count (ANC) \>= 1,500/mcl
Platelets \>= 100,000/mcl
Creatinine =\< upper limit of normal (ULN) or calculated creatinine clearance \>= 60 mL/min
Bilirubin =\< 1.5 x normal
Alkaline phosphate =\< 3 x normal
Serum glutamic oxaloacetic transaminase (SGOT) =\< 3 x normal
Gynecologic Oncology Group (GOG) performance status 0, 1, 2
+3 more criteria

You may not qualify if:

Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins
Patients with septicemia or severe infection
Patients with intestinal obstruction or gastrointestinal bleeding
Patients with postoperative fistula
Patients with cervix cancer who have received any previous radiation or chemotherapy
Patients whose circumstances do not permit completion of the study or the required follow-up
Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.)
Patients with GOG performance status of 3 or 4
Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

GOG Foundationlead
National Cancer Institute (NCI)collaborator

Study Sites (719)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC