Clinical trial · Interventional
Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery
Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy (NCT #01101451)
- 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 radiation therapy with chemotherapy to see how well they work compared to radiation therapy alone in treating patients with stage I-IIA cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.
Conditions
Conditions (7)
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 IA Cervical Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IB Cervical Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage I Cervical Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIA Cervical Cancer AJCC v7 | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| External Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (EBRT, IMRT)
- description
- Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5.5 weeks.
- interventionNames
- Radiation: External Beam Radiation Therapy
- Radiation: Intensity-Modulated Radiation Therapy
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Arm II (cisplatin, EBRT, IMRT)
- description
- Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Cisplatin
- Radiation: External Beam Radiation Therapy
- Radiation: Intensity-Modulated Radiation Therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy
* Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed):
* Positive capillary-lymphovascular space involvement and one of the following:
* Deep third penetration
* Middle third penetration, clinical tumor \>= 2 cm
* Superficial third penetration, clinical tumor \>= 5 cm
* Negative capillary-lymphatic space involvement
* Middle or deep third penetration, clinical tumor \>= 4 cm
* Absolute neutrophil count (ANC) \>= 1,500/mcl
* Platelets \>= 100,000/mcl
* Creatinine =\< upper limit of normal (ULN) or calculated creatinine clearance \>= 60 mL/min
* Bilirubin =\< 1.5 x normal
* Alkaline phosphate =\< 3 x normal
* Serum glutamic oxaloacetic transaminase (SGOT) =\< 3 x normal
* Gynecologic Oncology Group (GOG) performance status 0, 1, 2
* Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery
* Patients who have met the pre-entry requirements
* Patients must have signed an approved informed consent and authorization permitting release of personal health information
Exclusion Criteria:
* Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins
* Patients with septicemia or severe infection
* Patients with intestinal obstruction or gastrointestinal bleeding
* Patients with postoperative fistula
* Patients with cervix cancer who have received any previous radiation or chemotherapy
* Patients whose circumstances do not permit completion of the study or the required follow-up
* Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.)
* Patients with GOG performance status of 3 or 4
* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapyReferences
Publications (2)
- DERIVEDRyu SY, Deng W, Albuquerque K, Koh WJ, Mayadev J, Heugel A, Kim BJ, Kim DY, Cho CH, Kim JW, No JH, Mannel RS, Miller K, Fabian D, Chase DM, Gil KM, Small W Jr, Rodgers W, Leath CA 3rd, Monk BJ. Randomized phase III trial of adjuvant radiation versus chemoradiation in intermediate-risk, early-stage cervical cancer following radical hysterectomy and lymphadenectomy: results from NRG Oncology/GOG-263/KGOG 1008. Ann Oncol. 2025 Dec;36(12):1514-1524. doi: 10.1016/j.annonc.2025.09.003. Epub 2025 Sep 12. PMID 40947016
- DERIVEDKim H, Park W, Kim YS, Kim YJ. Chemoradiotherapy is not superior to radiotherapy alone after radical surgery for cervical cancer patients with intermediate-risk factor. J Gynecol Oncol. 2020 May;31(3):e35. doi: 10.3802/jgo.2020.31.e35. Epub 2019 Nov 21. PMID 31912685