Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01101451 · ClinicalTrials.gov registry record · Phase 3
Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery
A Phase 3 study of Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, sponsored by GOG Foundation.
- Completed
- Registry status
- Phase 3
- Development phase
- 340
- Enrollment target
- 20
- Study locations
NCT01101451: Completed Phase 3 study of Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, sponsored by GOG Foundation.
NCT01101451 is a Phase 3 study of Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma that has completed, run by GOG Foundation. The registered enrollment target is 340 participants, above the 98-participant average among 13 other Cervical Adenocarcinoma trials with a reported enrollment target (247% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01101451, a Phase 3 study of Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, has completed, sponsored by GOG Foundation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 340 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Cisplatin
- OTHER Quality-of-Life Assessment
- RADIATION External Beam Radiation Therapy
- OTHER Laboratory Biomarker Analysis
- RADIATION Intensity-Modulated Radiation Therapy
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Regional Hospital - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
California
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Mills-Peninsula Medical Center - Burlingame
Arizona
- Cancer Center at Saint Joseph's - Phoenix
- Saint Joseph's Hospital and Medical Center - Phoenix
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2010-04-12 |
| Est. Completion | 2024-04-02 |
| Phase | Phase 3 |
What the finished NCT01101451 record still lists
NCT01101451 is an interventional study that assigns participants to a tested intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap, above the 98-participant average among 13 other Cervical Adenocarcinoma trials with a reported enrollment target (247% higher).
The record links to 7 conditions, with Cervical Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT01101451 names 20 study sites across 4 states, led by Alaska, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01101451 about?
NCT01101451 is a clinical study titled "Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery". 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 ...
What is the current status of trial NCT01101451?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 340 participants. The study started on 2010-04-12. Estimated completion is 2024-04-02.
What conditions does trial NCT01101451 study?
This clinical trial studies the following conditions: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IIA Cervical Cancer AJCC v7, Stage I Cervical Cancer AJCC v6 and v7.
What interventions are being tested in trial NCT01101451?
The interventions under investigation include: Cisplatin (DRUG), Quality-of-Life Assessment (OTHER), External Beam Radiation Therapy (RADIATION), Laboratory Biomarker Analysis (OTHER), Intensity-Modulated Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT01101451?
This trial is sponsored by GOG Foundation, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01101451 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cervical Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01101451's enrollment target sits among peer trials
340 2nd of 13 the highest of 13 other Cervical Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers
ACTIVE NOT RECRUITING · Phase 3
-
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
RECRUITING · Phase 1
-
AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
RECRUITING · Phase 1
-
External Beam Radiation Therapy and Brachytherapy With Chemotherapy and Immunotherapy for the Treatment of Stage IVB Cervical Cancer
RECRUITING · Phase 1
-
Yoga Therapy During Chemotherapy and Radiation Treatment for the Improvement of Physical and Emotional Well-Being in Patients With Stage IB2-IIIB Cervical Cancer
ACTIVE NOT RECRUITING · NA
-
Nivolumab in Treating Patients With Persistent, Recurrent, or Metastatic Cervical Cancer
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04176172 · 340 participants · Phase 3
Optimizing Tobacco Use Treatment for PLWHA
- NCT04545424 · 340 participants · Phase 2
Trial of Therapeutic Hypothermia in Patients With ARDS
- NCT04806958 · 340 participants · NA
The PulsePoint Study
- NCT05323409 · 340 participants · NA
Improving Comprehensive Care of Cancer Patients
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI