Phase 3
N=926
Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer
Cervical Adenocarcinoma · Cervical Adenosquamous Carcinoma · Cervical Squamous Cell Carcinoma, Not Otherwise Specified · Stage IB Cervical Cancer AJCC v6 and v7 · Stage IIA Cervical Cancer AJCC v7
Bottom Line
View on ClinicalTrials.gov: NCT01414608 ↗Enrolled (actual)
926
Serious AEs
25.2%
Results posted
Nov 2022
Primary outcome: Primary: Overall Survival Rate at 5 Years — 71; 72 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brachytherapy (Radiation); Carboplatin (Drug); Cisplatin (Drug); External Beam Radiation Therapy (Radiation); Paclitaxel (Drug); Quality-of-Life Assessment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- GOG Foundation
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival Rate at 5 Years |
71; 72 | — |
| SECONDARY Progression-free Survival Rate at 5 Years |
62; 63 | — |
| SECONDARY Number of Participants With Adverse Events (Grade 3 or Higher) in First Year |
13; 14; 4; 2; 1; 2 | — |
| SECONDARY Patterns of Disease Recurrence |
15; 5; 33; 47; 51; 42 | — |
| SECONDARY Radiation Protocol Compliance |
45.6; 45.7 | — |
| SECONDARY Quality of Life for Global Health Status |
1.7; 2.4 | — |
Summary
This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with cervical cancer has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kills more tumor cells.
Eligibility Criteria
Inclusion Criteria
- Eligible patients will have locally advanced cervical cancer suitable for primary treatment with chemoradiation with curative intent, in addition to:
- Federation of Gynecology and Obstetrics (FIGO) 2008 stage IB1 & node positive, IB2, IIA, IIB, IIIB, or IVA disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix
- White blood cells (WBC) >= 3.0 x 10^9/L
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
- Platelet count >= 100 x 10^9/L
- Bilirubin = = 60 mL/min OR >= 50 mL/min by ethylenediaminetetraacetic acid (EDTA) creatinine clearance
- Written informed consent
Exclusion Criteria
- Any previous pelvic radiotherapy
- Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, PET positive, or >= 15 mm short-axis diameter on computed tomography [CT])
- FIGO 2008 stage IIIA disease
- Patients assessed at presentation as requiring interstitial brachytherapy treatment
- Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfills the required inclusion criteria
- Previous chemotherapy for this tumor
- Evidence of distant metastases
- Prior diagnosis of Crohn's disease or ulcerative colitis
- Peripheral neuropathy >= grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version [v]4)
- Patients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervical cancer therapy; this includes patients with a prior history of supracervical hysterectomy
- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 years
- Patients who are pregnant or lactating
- Any contraindication to the use of cisplatin, carboplatin, or paclitaxel chemotherapy
- Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients who are known to be human immunodeficiency virus (HIV) positive
Data sourced from ClinicalTrials.gov (NCT01414608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.