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Adjuvant chemotherapy for locally advanced cervical cancer patients

Randomized controlled trial comparing concurrent chemoradiation versus concurrent chemoradiation followed by adjuvant chemotherapy in locally advanced cervical cancer patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20140106001
Enrollment
500
Registered
2014-01-06
Start date
2014-01-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Locally advanced cervical cancer (FIGO stage IIB&#45

Interventions

Cisplatin 40 mg/ m2 weekly for 6 cycles in concurrent with pelvic radiation therapy,Cisplatin 40 mg/ m2 weekly for 6 cycles in concurrent with pelvic radiation therapy followed by paclitaxel 175 mg/m2
Active Comparator Other,Experimental Other

Sponsors

National Research Council of Thailand (NRCT)
Lead Sponsor
National Research Council of Thailand (NRCT)
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients must have: -aged 18-70 years -Cervical cancer FIGO stage IIB-IVA -squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma -ECOG performance status 0-2 -No history of other cancer except basal cell carcinoma -adequate bone marrow function) â´ÂÁÕ white blood cell > or = 3,000/mm3, granulocytes > or = 1,500/mm3, platelet count > or = 100,000/mm3 -bilirubin or = 40 mg/dl

Exclusion criteria

Exclusion criteria: -had para-aortic lymph node enlargement more than 1 cm or suspicious for cancer metastasis from CT or MRI -had adnexal mass from physical examination or imaging study -had chronic illnesses e.g. renal failure/ impairment, peripheral or central neuropathy, uncontrolled diabetes mellitus, or HIV infection. -Pregnant or lactating

Design outcomes

Primary

MeasureTime frame
Progression-free survival 3 years Kaplan Mier

Secondary

MeasureTime frame
Overall survival 3 years Kaplan Mier,response rate end of tretament percentages of response,Cost-utility analysis during and after treatment Cost & EQ-5D,side effects during and after treatment percentages

Contacts

Public ContactSiriwan Tangjitgamol

Faculty of Medicine Vajira Hospital, Navamindradhiraj University

siriwanonco@yahoo.com66-86-3841431

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026