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

Recruiting in Palo Alto (17 mi)

+40 other locations

Overseen byAkila Viswanathan

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Akila Viswanathan

Principal Investigator

Radiation Therapy Oncology Group

Eligibility Criteria

Inclusion Criteria

Endometrioid endometrial adenocarcinoma

Clear cell carcinoma

Papillary serous adenocarcinoma

See 7 more

Treatment Details

Interventions

Bevacizumab (Monoclonal Antibody)
Carboplatin (Platinum-based Chemotherapy)
Cisplatin (Platinum-based Chemotherapy)
Intensity-Modulated Radiation Therapy (Radiation)
Paclitaxel (Taxane)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (IMRT, cisplatin,bevacizumab,carboplatin,paclitaxel)Experimental Treatment5 Interventions

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.

Intensity-Modulated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as IMRT for: