Clinical trial · Interventional
Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer
A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Adenosquamous Carcinoma | Cervical Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IB Cervical Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIA Cervical Cancer AJCC v7 | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Cervical Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIIB Cervical Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Radiation | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| External Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (cisplatin, radiation therapy, brachytherapy)
- description
- Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate, pulsed-dose rate, or low-dose rate intracavitary brachytherapy.
- interventionNames
- Radiation: Brachytherapy
- Drug: Cisplatin
- Radiation: External Beam Radiation Therapy
- Other: Quality-of-Life Assessment
- type
- EXPERIMENTAL
- label
- Arm II (cisplatin, radiation therapy, brachytherapy, chemo)
- description
- Patients receive cisplatin and undergo external-beam radiation and brachytherapy as in arm I. Beginning 4 weeks later, patients also receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 =\< 1.5 times upper limit of normal (ULN) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2.5 x ULN (if both tests are done, both results need to be =\< 2.5 x ULN) * Creatinine =\< ULN (Common Toxicity Criteria \[CTC\] grade 0) OR calculated creatinine clearance (Cockcroft-Gault formula) \>= 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
References
Publications (2)
- DERIVEDMileshkin LR, Moore KN, Barnes EH, Gebski V, Narayan K, King MT, Bradshaw N, Lee YC, Diamante K, Fyles AW, Small W Jr, Gaffney DK, Khaw P, Brooks S, Thompson JS, Huh WK, Mathews CA, Buck M, Suder A, Lad TE, Barani IJ, Holschneider CH, Van Dyk S, Quinn M, Rischin D, Monk BJ, Stockler MR. Adjuvant chemotherapy following chemoradiotherapy as primary treatment for locally advanced cervical cancer versus chemoradiotherapy alone (OUTBACK): an international, open-label, randomised, phase 3 trial. Lancet Oncol. 2023 May;24(5):468-482. doi: 10.1016/S1470-2045(23)00147-X. Epub 2023 Apr 17. PMID 37080223
- DERIVEDGould HJ 3rd, Miller PR, Edenfield S, Sherman KJ, Brady CK, Paul D. Emergency Use of Targeted Osmotic Lysis for the Treatment of a Patient with Aggressive Late-Stage Squamous Cell Carcinoma of the Cervix. Curr Oncol. 2021 Jun 8;28(3):2115-2122. doi: 10.3390/curroncol28030196. PMID 34201380