NCT01005329|CompletedPhase 2Results

Intensity-Modulated Radiation Therapy, Cisplatin, and Bevacizumab Followed by Carboplatin and Paclitaxel in Treating Patients Who Have Undergone Surgery for Endometrial Cancer

A Phase II Study of Postoperative Intensity Modulated Radiation Therapy (IMRT) With Concurrent Cisplatin and Bevacizumab Followed by Carboplatin and Paclitaxel for Patients With Endometrial Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

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5 other identifiers

NCI-2011-01982CDR0000657979RTOG-0921RTOG 0921U10CA021661

Study Type

interventional

Target

Locations

3 countries

Sites

Timeline

RegisteredOct 2009

StartedNov 2009

CompletionSep 2013

Brief Summary

This phase II trial studies the side effects of giving intensity-modulated radiation therapy together with cisplatin and bevacizumab followed by carboplatin and cisplatin and to see how well they work in treating patients who have undergone surgery for high-risk endometrial cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving intensity-modulated radiation therapy together with chemotherapy and bevacizumab after surgery may kill any tumor cells that remain after surgery.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Nov 2009

Typical duration for phase_2

Geographic Reach

3 countries

41 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

3.9 years study duration

First Submitted

Initial submission to the registry

October 29, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed

7 days until next milestone

Study Start

First participant enrolled

November 6, 2009

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2012

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2013

Completed

5 months until next milestone

Results Posted

Study results publicly available

February 24, 2014

Completed

Last Updated

March 15, 2018

Status Verified

February 1, 2018

Enrollment Period

2.6 years

First QC Date

October 29, 2009

Results QC Date

January 8, 2014

Last Update Submit

February 15, 2018

Conditions

Endometrial Adenocarcinoma Endometrial Adenosquamous Carcinoma Endometrial Clear Cell Adenocarcinoma Endometrial Serous Adenocarcinoma Stage IA Uterine Corpus Cancer AJCC v7 Stage IB Uterine Corpus Cancer AJCC v7 Stage II Uterine Corpus Cancer AJCC v7 Stage IIIA Uterine Corpus Cancer AJCC v7 Stage IIIB Uterine Corpus Cancer AJCC v7 Stage IIIC Uterine Corpus Cancer AJCC v7 Stage IVA Uterine Corpus Cancer AJCC v7 Stage IVB Uterine Corpus Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 90 Days After Treatment Start
Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
From start of treatment to 90 days

Secondary Outcomes (6)

Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 1 Year After Treatment Start
From start of treatment to one year
Treatment-related Grade 3+ Adverse Events
From start of treatment to end of follow-up, up to 43.4 months; analysis occurred after all patients had been on study for at least one year.
Overall Survival (Two-year Rate Reported)
From registration to two years
Disease-free Survival (Two-year Rate Reported)
From registration to two years
Pelvic Failure Rate (Two-year Rate Reported)
From registration to two years
+1 more secondary outcomes

Study Arms (1)

Treatment (IMRT, cisplatin,bevacizumab,carboplatin,paclitaxel)

EXPERIMENTAL

Patients undergo pelvic IMRT once daily, 5 days a week, for 5 weeks. Patients may also undergo optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Patients also receive concurrent cisplatin IV over 1 hour on days 1 and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment with carboplatin and paclitaxel repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Biological: BevacizumabDrug: CarboplatinDrug: CisplatinRadiation: Intensity-Modulated Radiation TherapyDrug: Paclitaxel

Interventions

BevacizumabBIOLOGICAL

Given IV

Also known as: Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar FKB238, BEVACIZUMAB, LICENSE HOLDER UNSPECIFIED, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF