Chemo-Radiation for Early-Stage Cervical Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot have had prior systemic chemotherapy for cervical cancer or prior pelvic radiotherapy that overlaps with the trial's treatment areas.
What data supports the effectiveness of the treatment for early-stage cervical cancer?
Is chemo-radiation with cisplatin, carboplatin, and paclitaxel safe for humans?
Studies have shown that chemo-radiation using cisplatin, carboplatin, and paclitaxel is generally safe for treating cervical cancer, though it can have side effects. Researchers have evaluated the maximum tolerated doses and noted some toxicities, but these treatments are commonly used and considered safe under medical supervision.13678
What makes the chemo-radiation treatment for early-stage cervical cancer unique?
This treatment combines carboplatin, cisplatin, and paclitaxel with pelvic radiation, which is unique because it uses a combination of drugs that can enhance the effects of radiation therapy, potentially improving outcomes for early-stage cervical cancer. The use of carboplatin may also reduce kidney-related side effects compared to cisplatin alone.12359
What is the purpose of this trial?
RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer.PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.
Research Team
Anuja Jhingran, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for patients with high-risk early-stage cervical cancer who've had a radical hysterectomy. Eligible participants must have certain types of cervical cancer, no distant metastases, and their major organs functioning well. They should not have received prior chemotherapy or pelvic radiotherapy for the current cancer and must not have severe active co-morbidities.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Chemoradiotherapy
Patients undergo standard EBRT or IMRT to the pelvis once daily 5 days a week for 5-6 weeks with concurrent cisplatin IV once weekly for 6 weeks.
Adjuvant Chemotherapy
Patients receive paclitaxel and carboplatin IV every 21 days for 4 cycles, starting 4-6 weeks after chemoradiotherapy.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
Treatment Details
Interventions
- Carboplatin
- Cisplatin
- Paclitaxel
- Pelvic Radiation Therapy
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Radiation Therapy Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
NRG Oncology
Collaborator