Trial · NCT01414608

Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer

NCT01414608, Phase 3, Completed, GOG Foundation; results first posted 2022-11-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer. Trials, record NCT01414608. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01414608

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer
NCT number: NCT01414608
Status: Completed
Phases: Phase 3
Enrollment: 926 participants, actual
Lead sponsor: GOG Foundation
Conditions: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IB Cervical Cancer AJCC v6 and v7, Stage IIA Cervical Cancer AJCC v7, Stage IIB Cervical Cancer AJCC v6 and v7, Stage IIIB Cervical Cancer AJCC v6 and v7, Stage IVA Cervical Cancer AJCC v6 and v7
Interventions: Brachytherapy, Carboplatin, Cisplatin, External Beam Radiation Therapy, Paclitaxel, Quality-of-Life Assessment
First posted: 2011-08-11
Last updated: 2022-11-07
Results first posted: 2022-11-07

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival Rate at 5 Years	5 years from study randomization	Estimate for probability of overall survival at 5 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	Progression-free Survival Rate at 5 Years	5 years from study randomization	Estimate for probability of progression free at 5 years by Kaplan-Meier method, where progression-free survival is defined as the time from randomization to the time of disease progression, death from any cause or date of last contact, whichever occurs first. Disease progression is defined by increasing clinical, radiological or pathological evidence of disease from participant entry to when investigator deems a progression. RECIST V1.0 was not used to determine response on this study.
Secondary	Number of Participants With Adverse Events (Grade 3 or Higher) in First Year	1 year after randomization	Number of participants with a maximum grade of 3 or higher for pre-specified adverse events that occurred during the first year after randomization. Adverse events are graded and categorized using CTCAE v4.0.
Secondary	Patterns of Disease Recurrence	through study completion an average of 60 months	Number of patients for the site of disease recurrence. Disease was considered as persistent if participant had evidence of disease at study entry and disease did not progress during study. Disease status was considered locoregional alone if a participant had disease progression in the pelvis region including vagina after study entry. Disease status was considered distant if a participant had disease progression outside the pelvis (for example the abdomen and lung) after study entry. Criteria used to determine the no progression group includes participants that expired without documentation of progression.
Secondary	Radiation Protocol Compliance	Average duration of 7 weeks	Radiation protocol compliance measured by external beam dose delivered
Secondary	Quality of Life for Global Health Status	Baseline and 12 months	Quality of Life measured by change of global health status score from baseline to 12 months follow-up. A cancer-specific questionnaire with 30 items which summarize as five functioning scales, a global health status/quality of life scale, three symptom scales and six single items assessing additional symptoms and perceived financial impact. The minimum global health status score was 0 and the maximum global health status score was 100. A higher global health status score means better outcome.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival Rate at 5 Years	5 years from study randomization	Eligible subjects	Percentage of participants	NUMBER
SECONDARY	Progression-free Survival Rate at 5 Years	5 years from study randomization	Eligible participants	Percentage of participants	NUMBER
SECONDARY	Number of Participants With Adverse Events (Grade 3 or Higher) in First Year	1 year after randomization	Arm A:eligible participants who received at least one dose of cisplatin and/or any dose of radiotherapy. Arm B: eligible participants who received at least one dose of adjuvant chemotherapy (carboplatin, paclitaxel, cisplatin or docetaxel)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Patterns of Disease Recurrence	through study completion an average of 60 months	Eligible participants. The No Progression recorded group included participants who died due to any causes without documented progression.	participants	NUMBER
SECONDARY	Radiation Protocol Compliance	Average duration of 7 weeks	Eligible and received radiotherapy	Gray	MEAN
SECONDARY	Quality of Life for Global Health Status	Baseline and 12 months	Eligible participants with Quality of Life at baseline and 12 months	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group100

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Survival Rate at 5 Years	Standard Chemoradiation		71	95% Confidence Interval 66 to 75	Percentage of participants
Overall Survival Rate at 5 Years	Standard Chemoradiation With Adjuvant Chemotherapy		72	95% Confidence Interval 67 to 76	Percentage of participants
Progression-free Survival Rate at 5 Years	Standard Chemoradiation		62	95% Confidence Interval 57 to 66	Percentage of participants
Progression-free Survival Rate at 5 Years	Standard Chemoradiation With Adjuvant Chemotherapy		63	95% Confidence Interval 58 to 68	Percentage of participants
Number of Participants With Adverse Events (Grade 3 or Higher) in First Year	Standard Chemoradiation	Abdominal pain	13		Participants
Number of Participants With Adverse Events (Grade 3 or Higher) in First Year	Standard Chemoradiation With Adjuvant Chemotherapy	Abdominal pain	14		Participants
Number of Participants With Adverse Events (Grade 3 or Higher) in First Year	Standard Chemoradiation	Alanine aminotransferase increased	4		Participants
Number of Participants With Adverse Events (Grade 3 or Higher) in First Year	Standard Chemoradiation With Adjuvant Chemotherapy	Alanine aminotransferase increased	2		Participants
Number of Participants With Adverse Events (Grade 3 or Higher) in First Year	Standard Chemoradiation	Allergic reaction/hypersensitivity	1		Participants
Number of Participants With Adverse Events (Grade 3 or Higher) in First Year	Standard Chemoradiation With Adjuvant Chemotherapy	Allergic reaction/hypersensitivity	2		Participants

1 to 10 of 100Source ClinicalTrials.gov

See all 100 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Standard Chemoradiation	461
Overall Study	STARTED	Standard Chemoradiation With Adjuvant Chemotherapy	465
Overall Study	COMPLETED	Standard Chemoradiation	456
Overall Study	COMPLETED	Standard Chemoradiation With Adjuvant Chemotherapy	463
Overall Study	NOT COMPLETED	Standard Chemoradiation	5
Overall Study	NOT COMPLETED	Standard Chemoradiation With Adjuvant Chemotherapy	2

Source ClinicalTrials.gov

Adverse events102

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
other	Abdominal pain	Gastrointestinal disorders	Standard Chemoradiation	160	453
other	Abdominal pain	Gastrointestinal disorders	Standard Chemoradiation With Adjuvant Chemotherapy	164	361
other	Alanine aminotransferase increased	Investigations	Standard Chemoradiation	76	453
other	Alanine aminotransferase increased	Investigations	Standard Chemoradiation With Adjuvant Chemotherapy	98	361
other	Allergic reaction/ hypersensitivity	Immune system disorders	Standard Chemoradiation	20	453
other	Allergic reaction/ hypersensitivity	Immune system disorders	Standard Chemoradiation With Adjuvant Chemotherapy	32	361
other	Alopecia	Skin and subcutaneous tissue disorders	Standard Chemoradiation	36	453
other	Alopecia	Skin and subcutaneous tissue disorders	Standard Chemoradiation With Adjuvant Chemotherapy	285	361
other	Anal pain	Gastrointestinal disorders	Standard Chemoradiation	15	453
other	Anal pain	Gastrointestinal disorders	Standard Chemoradiation With Adjuvant Chemotherapy	6	361

1 to 10 of 102Source ClinicalTrials.gov

See all 102 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard Chemoradiation	123	456
Total, all-cause mortality	Standard Chemoradiation With Adjuvant Chemotherapy	109	463
Total, other adverse events	Standard Chemoradiation	438	453
Total, other adverse events	Standard Chemoradiation With Adjuvant Chemotherapy	360	361
Total, serious adverse events	Standard Chemoradiation	98	453
Total, serious adverse events	Standard Chemoradiation With Adjuvant Chemotherapy	107	361

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34201380	DERIVED	PubMed
37080223	DERIVED	PubMed

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
Standard Chemoradiation vs Standard Chemoradiation With Adjuvant Chemotherapy: deaths from any cause	Trial comparisons
Standard Chemoradiation vs Standard Chemoradiation With Adjuvant Chemotherapy: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01414608

GET https://conductscience.org/api/trials/v1/NCT01414608/results?page=2

API reference For AI assistants