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Comparison of Different Subsequent Treatments After Radical Surgery

Comparison of Different Adjuvant Treatments Following Radical Surgery in Early Stage Cervical Carcinoma

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00806117
Acronym
STARS
Enrollment
1080
Registered
2008-12-10
Start date
2008-02-25
Completion date
2020-12-31
Last updated
2019-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

Cervical cancer, Concurrent chemoradiation, Randomized controlled clinical trials

Brief summary

Cervical cancer is still the most common gynecologic cancer. There was no obvious increase of the survival over years. The risk of recurrence after radical surgery has increased with positive lymph nodes, positive surgical margins, positive lymphatic vascular space and deep invasion of the cervical stroma. In recent years, the role of chemotherapy for cervical cancer has been gradually recognized. But as a adjuvant therapy post-surgery, if chemotherapy can improve the overall survival rate of patients with adverse pathological prognostic factors is inconclusive. In this study, in order to investigate the effect and adverse reaction of chemotherapy as the adjuvant therapy post-surgery on patients with adverse pathological prognostic factors, nine hundred and ninety patients will be randomly divided into three groups, comparing radiotherapy alone, concurrent chemoradiation and sequence chemotherapy and radiotherapy (2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation). The investigators aim to find out the best therapeutic regimen with lowest adverse reaction for cervical cancer with adverse pathological prognostic factors. To guide clinical treatment options.

Detailed description

After radical surgery, patients with stage IB1 to IIA2 cervical cancer who had one or more following pathological factors were recruited: lymph node metastases (LNM), positive parametrium or margins (PPM), lymphatic vascular space involvement (LVSI), deep invasion of cervical stromal (DIS). Eligible patients were randomized to three groups. Group A underwent 50 GY RT alone. Group B received concurrent weekly cisplatin and RT. Group C received paclitaxel and bolus cisplatin every three weeks for two cycles before RT, followed by two cycles. We have recruited 800 patients till November 2014.

Interventions

External irradiation 50Gy/5 weeks * Lateral: 2 cm lateral to the bony margin of the pelvis * Superior: Between L5 and S1 * Inferior: 2 cm below the obturator foramen Intracavitary boost 30-35Gy/4 weeks(positive vaginal margins only)

OTHERConcurrent chemoirradiation (CCRT)

Cisplatin 40mg/m2 every week during external irradiation

OTHERSequence chemotherapy and radiotherapy (SCRT)

Paclitaxel 135\ 175mg/m2 over 3 hours Cisplatin 60\ 75mg/m2

Sponsors

Guangdong Provincial People's Hospital
CollaboratorOTHER
First Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
Shenzhen People's Hospital
CollaboratorOTHER
Cancer Hospital of Guangxi Medical University
CollaboratorOTHER
Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

After radical surgery, eligible patients with risk pathological factors were randomize to three groups. Radiotherapy: Group A underwent 50 GY pelvic RT alone. Radiotherapy and drugs: Group B received concurrent weekly cisplatin and RT (CCRT). Radiotherapy and drugs: Group C received paclitaxel and bolus cisplatin every three weeks for two cycles before RT, followed by two cycles of chemotherapy (SCRT).

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients with newly histologically confirmed cervical carcinoma * Original clinical stage must be Ib\ IIa (FIGO) * Age between 18-65 * With the presence of these four factors after radical surgery:(1)positive lymph nodes,(2)positive parametria, or positive surgical margins,(3)positive lymphatic vascular space,(4)outer one-third invasion of the cervical stroma * More than 3 months survival is to expect * Patients must give signed informed consent

Exclusion criteria

* The presence of uncontrolled life-threatening illness * Receiving other ways of anti-cancer therapy * Residual tumor which can not be removed in the surgery * Investigator consider the patients can't finish the whole study * With normal liver function test (ALT、AST\>2.5×ULN) * With normal renal function test (Creatinine\>1.5×ULN) * WBC\<4,000/mm3 or PLT\<100,000/mm3 * Receive the external pelvic irradiation before the surgery

Design outcomes

Primary

MeasureTime frameDescription
Disease Free Survival3-YrDFS survival analysis

Secondary

MeasureTime frameDescription
Overall Survival5-YrOS survival analysis

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026