Trial purpose
Cancer treatment
Tumor type
Gynaecological
Age
18 - 75
Clinical summary
Summary
This study looks at whether the addition of adjuvant chemotherapy to standard cisplatin-based chemoradiation improves outcomes in women with locally advanced cervical cancer. Who is it for? You can join this study if you have locally advanced cervical cancer which is suitable for primary treatment with chemoradiation and you have not received any previous pelvic radiotherapy. Trial details: Participants will be divided into two groups. Both groups will be treated with standard external beam radiation treatment to the pelvis and brachytherapy(internal radiotherapy). They will receive cisplatin intravenously during the radiation at a dose of 40mg/m2 weekly for 5 doses. One group will also receive 4 cycles of 3 weekly adjuvant chemotherapy using carboplatin and paclitaxel intravenously, beginning within 4 weeks of completion of all radiation treatment. The study aims to see whether the adjuvant chemotherapy increases the response to treatment and improves survival times.
Conditions
This trial is treating people with Cervical Cancer
Eligibility
Exclusion
- 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
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR, ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
National Cancer Institute (NCI),Australia New Zealand Gynaecological Oncology Group (ANZGOG)
Scientific Title
A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial
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