Chemo-Radiation for Early-Stage Cervical Cancer

Recruiting in Palo Alto (17 mi)

+124 other locations

Overseen byAnuja Jhingran, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Radiation Therapy Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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

Hemoglobin ≥ 10.0 g/dL

Serum creatinine ≤ 1.5 mg/dL

My cancer does not have neuroendocrine features.

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Exclusion Criteria

I do not have a severe lung condition that would stop me from joining the study.

I have had previous radiation treatment to my pelvis.

I have not been hospitalized for heart issues in the last 6 months.

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Treatment Details

Interventions

Carboplatin (Platinum-based Chemotherapy)
Cisplatin (Platinum-based Chemotherapy)
Paclitaxel (Taxane Chemotherapy)
Pelvic Radiation Therapy (Radiation)

Trial OverviewThe study is testing how effective chemotherapy (cisplatin, paclitaxel, carboplatin) combined with pelvic radiation therapy is compared to the same treatment plus additional chemotherapy in treating high-risk early-stage cervical cancer post-surgery.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II: Cisplatin/Radiation Therapy + Carboplatin/PaclitaxelExperimental Treatment6 Interventions

Chemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV \[135 mg/m2, with maximum body surface area (BSA) of 2.0 m\^2 over 3 hours\] and carboplatin IV \[area under the curve (AUC) 5 over 30 minutes\] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm I: Cisplatin/Radiation TherapyActive Control4 Interventions

Standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m\^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional.

Carboplatin is already approved in Canada for the following indications: