Trial · NCT00980954
Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy
NCT00980954, Phase 3, Completed, Radiation Therapy Oncology Group; results first posted 2024-11-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy. Trials, record NCT00980954. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00980954
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy
- NCT number
- NCT00980954
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 236 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Cervical Cancer
- Interventions
- carboplatin, cisplatin, paclitaxel, intensity-modulated radiation therapy, standard external beam radiation therapy, Optional brachytherapy boost
- First posted
- 2009-09-21
- Last updated
- 2025-12-31
- Results first posted
- 2024-11-06
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free Survival (Percentage of Participants Alive Without Disease) | From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported. | Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants. |
| Secondary | Overall Survival (Percentage of Participants Alive) | From randomization to death or last follow-up. Maximum follow-up time at time of analysis was 12.8 years. The 2- and 4-year survival estimates are reported. | Overall survival is estimated by the Kaplan-Meier method. The distribution of survival estimates between the two arms is compared using the log rank test. Survival time is measured from the date of randomization to the date of death from any cause or last known follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants. |
| Secondary | Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) at 12 Months | Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks) | The FACT-GOG/NTX4 measures patient-reported symptoms of chemotherapy-induced peripheral neuropathy in cancer patients. Possible scores range from 0 to 16 with higher scores indicating a better condition. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms. |
| Secondary | Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) Diarrhea Subscore at 12 Months | Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks) | The diarrhea-specific subscore of the FACIT-D measures patient-reported diarrhea symptoms. Possible scores range from 0 to 44 with higher scores indicating a better quality of life. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms. |
| Secondary | Functional Assessment of Cancer Therapy - Cervix (FACT-Cx) Cervical Cancer Subscore at 12 Months | Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks) | The cervical cancer subscore of the FACT-Cx measures patient-reported symptoms and problems related to cervical cancer. Possible scores range from 0 to 60 with higher scores indicating a better quality of life. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms. |
| Secondary | Number of Participants by Highest Grade Adverse Event Reported | From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years. | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. |
| Secondary | Associations Between Tumor Molecular Signatures, From Fixed Tissue, and Outcomes Such as Adverse Events, Disease Free Survival and Overall Survival | From randomization to last follow-up | |
| Secondary | Associations Between Secreted Factors From Serum and Plasma With Adverse Events or Outcome | From randomization to last follow-up. | |
| Secondary | Associations Between Single Nucleotide Polymorphisms (SNPs) in Genes From Buffy Coat and a Genetic Predisposition to Tumor Formation Itself or a Response to Cytotoxic Therapy | From randomization to last follow-up. | |
| Other | Disease-free Survival (Percentage of Participants Alive Without Disease) by Ethnicity | From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported. | NIH-required analysis. Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease-free Survival (Percentage of Participants Alive Without Disease) | From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (Percentage of Participants Alive) | From randomization to death or last follow-up. Maximum follow-up time at time of analysis was 12.8 years. The 2- and 4-year survival estimates are reported. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) at 12 Months | Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks) | |||
| SECONDARY | Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) Diarrhea Subscore at 12 Months | Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks) | |||
| SECONDARY | Functional Assessment of Cancer Therapy - Cervix (FACT-Cx) Cervical Cancer Subscore at 12 Months | Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks) | |||
| SECONDARY | Number of Participants by Highest Grade Adverse Event Reported | From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years. | Eligible participants who started protocol treatment and were assessed for adverse events. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Associations Between Tumor Molecular Signatures, From Fixed Tissue, and Outcomes Such as Adverse Events, Disease Free Survival and Overall Survival | From randomization to last follow-up | The protocol did not provide sufficient detail to meet current National Cancer Institute requirements for release of specimens from the NRG Oncology tissue bank for the protocol-specified objective, therefore no assays were performed, and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial. | ||
| SECONDARY | Associations Between Secreted Factors From Serum and Plasma With Adverse Events or Outcome | From randomization to last follow-up. | The protocol did not provide sufficient detail to meet current National Cancer Institute requirements for release of specimens from the NRG Oncology tissue bank for the protocol-specified objective, therefore no assays were performed, and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial. | ||
| SECONDARY | Associations Between Single Nucleotide Polymorphisms (SNPs) in Genes From Buffy Coat and a Genetic Predisposition to Tumor Formation Itself or a Response to Cytotoxic Therapy | From randomization to last follow-up. | The protocol did not provide sufficient detail to meet current National Cancer Institute requirements for release of specimens from the NRG Oncology tissue bank for the protocol-specified objective, therefore no assays were performed, and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial. | ||
| OTHER_PRE_SPECIFIED | Disease-free Survival (Percentage of Participants Alive Without Disease) by Ethnicity | From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported. | Eligible participants stratified by ethnicity | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-free Survival (Percentage of Participants Alive Without Disease) | Arm I: Cisplatin/Radiation Therapy | 2 years | 86.4 | 90% Confidence Interval 80.8 to 92.0 | percentage of participants |
| Disease-free Survival (Percentage of Participants Alive Without Disease) | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 2 years | 82.1 | 90% Confidence Interval 75.6 to 88.6 | percentage of participants |
| Disease-free Survival (Percentage of Participants Alive Without Disease) | Arm I: Cisplatin/Radiation Therapy | 4 years | 76.2 | 90% Confidence Interval 69.1 to 83.4 | percentage of participants |
| Disease-free Survival (Percentage of Participants Alive Without Disease) | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 4 years | 76.9 | 90% Confidence Interval 69.6 to 84.3 | percentage of participants |
| Overall Survival (Percentage of Participants Alive) | Arm I: Cisplatin/Radiation Therapy | 2 years | 91.9 | 90% Confidence Interval 87.4 to 96.4 | percentage of participants |
| Overall Survival (Percentage of Participants Alive) | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 2 years | 91.4 | 90% Confidence Interval 86.6 to 96.2 | percentage of participants |
| Overall Survival (Percentage of Participants Alive) | Arm I: Cisplatin/Radiation Therapy | 4 years | 87.3 | 90% Confidence Interval 81.6 to 93.0 | percentage of participants |
| Overall Survival (Percentage of Participants Alive) | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 4 years | 89.0 | 90% Confidence Interval 83.5 to 94.4 | percentage of participants |
| Number of Participants by Highest Grade Adverse Event Reported | Arm I: Cisplatin/Radiation Therapy | Grade 1 | 13 | Participants | |
| Number of Participants by Highest Grade Adverse Event Reported | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | Grade 1 | 4 | Participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I: Cisplatin/Radiation Therapy | 118 | |
| Overall Study | STARTED | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 118 | |
| Overall Study | Eligible | Arm I: Cisplatin/Radiation Therapy | 109 | |
| Overall Study | Eligible | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 103 | |
| Overall Study | COMPLETED | Arm I: Cisplatin/Radiation Therapy | 109 | |
| Overall Study | COMPLETED | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 103 | |
| Overall Study | NOT COMPLETED | Arm I: Cisplatin/Radiation Therapy | 9 | |
| Overall Study | NOT COMPLETED | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 15 |
Source ClinicalTrials.gov
Adverse events242
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 | Anemia | Blood and lymphatic system disorders | Arm I: Cisplatin/Radiation Therapy | 48 | 107 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 60 | 101 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm I: Cisplatin/Radiation Therapy | 10 | 107 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 7 | 101 | |
| other | Chest pain - cardiac | Cardiac disorders | Arm I: Cisplatin/Radiation Therapy | 3 | 107 | |
| other | Chest pain - cardiac | Cardiac disorders | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 6 | 101 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm I: Cisplatin/Radiation Therapy | 3 | 107 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 6 | 101 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm I: Cisplatin/Radiation Therapy | 19 | 107 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 21 | 101 |
1 to 10 of 242Source ClinicalTrials.gov
See all 242 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I: Cisplatin/Radiation Therapy | 17 | 109 |
| Total, all-cause mortality | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 13 | 103 |
| Total, other adverse events | Arm I: Cisplatin/Radiation Therapy | 103 | 107 |
| Total, other adverse events | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 99 | 101 |
| Total, serious adverse events | Arm I: Cisplatin/Radiation Therapy | 14 | 107 |
| Total, serious adverse events | Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel | 25 | 101 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I: Cisplatin/Radiation Therapy vs Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel: deaths from any cause | Trial comparisons |
| Arm I: Cisplatin/Radiation Therapy vs Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel: 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.
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