NCT00980954

Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in High-Risk Patients With Early-Stage Cervical Carcinoma Following Radical Hysterectomy

Completed Phase 3 Results posted Last updated 10 December 2025

What this trial tests

Phase 3 trial testing carboplatin in Cervical Cancer in 236 participants. Completed in 4 September 2025.

Timeline

1 September 2009

Primary endpoint
14 December 2023

4 September 2025

Quick facts

Lead sponsor	Radiation Therapy Oncology Group
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	236
Start date	1 September 2009
Primary completion	14 December 2023
Estimated completion	4 September 2025
Sites	125 locations across United States, Canada, Hong Kong, South Korea

Drugs / interventions tested

• carboplatin (Carboplatin) — full drug profile →
• cisplatin (cisplatin) — full drug profile →
• paclitaxel — full drug profile →
• intensity-modulated radiation therapy
• standard external beam radiation therapy
• Optional brachytherapy boost

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →

Sponsor

Radiation Therapy Oncology Group — full company profile →

Who can join

18 and older, female only, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Disease-free Survival (Percentage of Participants Alive Without Disease)
  Time frame: From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported.
  Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was r

Sponsor's own description

RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Management and Care of Women With Invasive Cervical Cancer: American Society of Clinical Oncology Resource-Stratified Clinical Practice Guideline.
   Chuang LT, Temin S, Camacho R, Dueñas-Gonzalez A, et al · · 2016 · cited 134× · PMID 28717717 · DOI 10.1200/jgo.2016.003954
2. HPV Sequencing Facilitates Ultrasensitive Detection of HPV Circulating Tumor DNA.
   Leung E, Han K, Zou J, Zhao Z, et al · · 2021 · cited 70× · PMID 34580115 · DOI 10.1158/1078-0432.ccr-19-2384
3. Evidence-Based Treatment Paradigms for Management of Invasive Cervical Carcinoma.
   Tewari KS, Monk BJ. · · 2019 · cited 30× · PMID 31403858 · DOI 10.1200/jco.18.02303
4. Cervical cancer heterogeneity: a constant battle against viruses and drugs.
   Sun Q, Wang L, Zhang C, Hong Z, et al · · 2022 · cited 28× · PMID 36397138 · DOI 10.1186/s40364-022-00428-7
5. Should the Number of Metastatic Pelvic Lymph Nodes be Integrated into the 2018 Figo Staging Classification of Early Stage Cervical Cancer?
   Pedone Anchora L, Carbone V, Gallotta V, Fanfani F, et al · · 2020 · cited 28× · PMID 32545508 · DOI 10.3390/cancers12061552
6. Phase II study of adjuvant chemotherapy with paclitaxel and nedaplatin for uterine cervical cancer with lymph node metastasis.
   Takekuma M, Shimokawa M, Nishio S, Omi H, et al · · 2018 · cited 14× · PMID 29575254 · DOI 10.1111/cas.13577
7. Predicting prognosis according to the updated WHO classification in patients with endocervical adenocarcinoma treated with surgery and radiotherapy.
   Cho WK, Kim HS, Park W, Chang CS, et al · · 2022 · cited 10× · PMID 36047374 · DOI 10.3802/jgo.2022.33.e71
8. Clinical trials in gynecologic oncology: Past, present, and future.
   Annunziata CM, Kohn EC. · · 2018 · cited 8× · PMID 29212614 · DOI 10.1016/j.ygyno.2017.11.026