Trial · NCT01101451
Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery
NCT01101451, Phase 3, Completed, GOG Foundation; results first posted 2025-05-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery. Trials, record NCT01101451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01101451
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery
- NCT number
- NCT01101451
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 340 participants, actual
- Lead sponsor
- GOG Foundation
- 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
- Interventions
- Cisplatin, External Beam Radiation Therapy, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration
- First posted
- 2010-04-12
- Last updated
- 2025-05-23
- Results first posted
- 2025-05-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrence-free Survival (RFS) Rate at 3-years | 3 years from randomization | 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. |
| Secondary | Overall Survival (OS) Rate at 3-years | 3 years from randomization | Estimate for probability of overall survival at 3 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first. |
| Secondary | 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. | Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0. |
| Secondary | Patient Risk-benefit | up to 11 years | The reporting group (2) did not demonstrate improved RFS compared to the reporting group (1) at the pre-specified significance level. Per the protocol, patient risk-benefit will be assessed only for a positive study. This is not assessed due to non-positive study per the protocol. |
| Secondary | 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. | The patient-reported QOL is assessed with the Trial Outcome Index of the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx TOI). The FACT-Cx TOI is ranged 0-116 and a larger FACT-Cx TOI score suggests a favorable QoL. |
| Other | Treatment Compliance | Up to 11 years | Assessed by the number of cycles and amount of chemoradiotherapy administered, treatment span, incidence and duration of treatment delays, reason for delays, and reason why off study therapy. |
| Other | Site(s) of Recurrence | Up to 11 years | The site(s) of first disease recurrence will be classified as: pelvic-only, extra-pelvic-only or pelvic-and-extra-pelvic and tabulated by treatment group. The test of the hypothesis that the probability of local failure is independent of randomized treatment will be assessed with exact logistic regression adjusted know prognostic factors. |
| Other | Local Control | Up to 11 years | Assessed with Exact Logistic Regression adjusted known prognostic factors. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recurrence-free Survival (RFS) Rate at 3-years | 3 years from randomization | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) Rate at 3-years | 3 years from randomization | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | 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. | Randomized participants who received any assigned protocol therapy | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Risk-benefit | up to 11 years | Per protocol, patient risk-benefit will be assessed only for a positive study. Based on the results information at the specified significance level, patient risk-benefit was not assessed as pre-specified | ||
| SECONDARY | 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. | Eligible patients who completed baseline and at lease one follow-up QOL assessments. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Treatment Compliance | Up to 11 years | |||
| OTHER_PRE_SPECIFIED | Site(s) of Recurrence | Up to 11 years | |||
| OTHER_PRE_SPECIFIED | Local Control | Up to 11 years |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recurrence-free Survival (RFS) Rate at 3-years | Arm I (Radiation) | 85.4 | 95% Confidence Interval 79 to 90 | percentage of participants | |
| Recurrence-free Survival (RFS) Rate at 3-years | Arm II (Cisplatin + Radiation) | 88.5 | 95% Confidence Interval 82 to 93 | percentage of participants | |
| Overall Survival (OS) Rate at 3-years | Arm I (Radiation) | 90.3 | 95% Confidence Interval 84 to 94 | percentage of participants | |
| Overall Survival (OS) Rate at 3-years | Arm II (Cisplatin + Radiation) | 97.2 | 95% Confidence Interval 93 to 99 | percentage of participants | |
| Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period. | Arm I (Radiation) | Anemia | 1 | Participants | |
| Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period. | Arm II (Cisplatin + Radiation) | Anemia | 6 | Participants | |
| Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period. | Arm I (Radiation) | Other blood/lymphatics | 0 | Participants | |
| Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period. | Arm II (Cisplatin + Radiation) | Other blood/lymphatics | 4 | Participants | |
| Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period. | Arm I (Radiation) | White blood cell decreased | 3 | Participants | |
| Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period. | Arm II (Cisplatin + Radiation) | White blood cell decreased | 45 | Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Radiation) | 172 | |
| Overall Study | STARTED | Arm II (Cisplatin + Radiation) | 168 | |
| Overall Study | COMPLETED | Arm I (Radiation) | 158 | |
| Overall Study | COMPLETED | Arm II (Cisplatin + Radiation) | 153 | |
| Overall Study | NOT COMPLETED | Arm I (Radiation) | 14 | |
| Overall Study | NOT COMPLETED | Arm II (Cisplatin + Radiation) | 15 |
Source ClinicalTrials.gov
Adverse events398
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood And Lymphatic System Disorders - Other | Blood and lymphatic system disorders | Arm I (Radiation) | 1 | 170 | |
| other | Blood And Lymphatic System Disorders - Other | Blood and lymphatic system disorders | Arm II (Cisplatin + Radiation) | 5 | 161 | |
| other | Anemia | Blood and lymphatic system disorders | Arm I (Radiation) | 63 | 170 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Cisplatin + Radiation) | 95 | 161 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Arm I (Radiation) | 0 | 170 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Arm II (Cisplatin + Radiation) | 2 | 161 | |
| other | Palpitations | Cardiac disorders | Arm I (Radiation) | 0 | 170 | |
| other | Palpitations | Cardiac disorders | Arm II (Cisplatin + Radiation) | 5 | 161 | |
| other | Paroxysmal Atrial Tachycardia | Cardiac disorders | Arm I (Radiation) | 1 | 170 | |
| other | Paroxysmal Atrial Tachycardia | Cardiac disorders | Arm II (Cisplatin + Radiation) | 0 | 161 |
1 to 10 of 398Source ClinicalTrials.gov
See all 398 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Radiation) | 20 | 158 |
| Total, all-cause mortality | Arm II (Cisplatin + Radiation) | 12 | 158 |
| Total, other adverse events | Arm I (Radiation) | 140 | 170 |
| Total, other adverse events | Arm II (Cisplatin + Radiation) | 158 | 161 |
| Total, serious adverse events | Arm I (Radiation) | 7 | 170 |
| Total, serious adverse events | Arm II (Cisplatin + Radiation) | 9 | 161 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Radiation) vs Arm II (Cisplatin + Radiation): deaths from any cause | Trial comparisons |
| Arm I (Radiation) vs Arm II (Cisplatin + Radiation): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01101451
GET https://conductscience.org/api/trials/v1/NCT01101451/results?page=2