Clinical trial · Interventional
the Re-irradiation of Recurrent Cervical Cancer by IMRT
A Prospective Study on the Efficacy and Safety of the Re-irradiation of Recurrent Cervical Cancer Within the Irradiated Field by Intensity Modulated Radiotherapy
- 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 is a prospective clinical trial using intensity modulated radiotherapy（IMRT）for the treatment of cervical cancer patients with recurrent disease within the previously irradiated field. Sixty patients will be enrolled after careful selection to meet the including criteria and excluding criteria. A primary course of 36Gy will be prescribed to the recurrent site and a further 9-24Gy of dose escalation will be prescribed to the gross tumor volume in the second course according to the toxicities and the shrinkage of tumor. Weekly concurrent cisplatin of 30mg/m2 by five weeks will be administrated intravenously to the selected patients. Acute and late toxicities will be monitored and survival endpoints will be tracked with our follow-up protocol to evaluate the safety and efficacy of this approach.
Conditions
Conditions (3)
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 Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Toxicity | — | UNRESOLVED | — |
| Recurrent Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intensity-modulated radiotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment
- description
- retreatment using intensity-modulated radiotherapy for cervical cancer patients with in-field recurrence
- interventionNames
- Device: intensity-modulated radiotherapy
Primary outcomes (1)
- measure
- 3 year progression free survival (PFS)
- timeFrame
- evaluate the response every 3 months since the completion of treatment until the progression of disease or death of patient up to 36 months
- description
- 3 year progression free survival
Secondary outcomes (1)
- measure
- 3 year recurrence free survival ( RFS)
- timeFrame
- evaluate the response every 3 months since the completion of treatment until the recurrence of disease or death of patient up to 36 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients have provided a signed Informed Consent Form. * Histologically confirmed cervical cancer patients after initial radiotherapy with in-field recurrence age 18-65 * Willing to have retreatment by radiotherapy * ECOG status 0～2，Karnofsky(KPS) score ≥80 * Normal internal organ function Exclusion Criteria: * Having the serious cardiovascular disease or other serious complications. * Woman in pregnancy and breast-feeding. * Patients who had other malignant tumors in five years . * Patients who had epilepsy. * Patients who had infectious diseases. * Patients who had severe side effects from previous treatment, such as intestinal disease, radiation induced pneumonia, diabetes, renal failure and hepatic failure.
References
Publications (6)
- BACKGROUNDAndreu-Martinez FJ, Martinez-Mateu JM. Hypoxia and anaemia in patients with cancer of the uterine cervix. Clin Transl Oncol. 2005 Sep;7(8):323-31. doi: 10.1007/BF02716547. PMID 16185600
- BACKGROUNDTimmer PR, Aalders JG, Bouma J. Radical surgery after preoperative intracavitary radiotherapy for Stage IB and IIA carcinoma of the uterine cervix. Gynecol Oncol. 1984 Jun;18(2):206-12. doi: 10.1016/0090-8258(84)90027-1. PMID 6735263
- BACKGROUNDMayr NA, Wen BC, Benda JA, Sorosky JI, Davis CS, Fuller RW, Hussey DH. Postoperative radiation therapy in clinical stage I endometrial cancer: corpus, cervical, and lower uterine segment involvement--patterns of failure. Radiology. 1995 Aug;196(2):323-8. doi: 10.1148/radiology.196.2.7617840. PMID 7617840
- BACKGROUNDLook KY, Rocereto TF. Relapse patterns in FIGO stage IB carcinoma of the cervix. Gynecol Oncol. 1990 Jul;38(1):114-20. doi: 10.1016/0090-8258(90)90021-c. PMID 2354816
- BACKGROUNDPotter ME, Alvarez RD, Shingleton HM, Soong SJ, Hatch KD. Early invasive cervical cancer with pelvic lymph node involvement: to complete or not to complete radical hysterectomy? Gynecol Oncol. 1990 Apr;37(1):78-81. doi: 10.1016/0090-8258(90)90312-9. PMID 2323617
- BACKGROUNDAnthopoulos AP, Manetta A, Larson JE, Podczaski ES, Bartholomew MJ, Mortel R. Pelvic exenteration: a morbidity and mortality analysis of a seven-year experience. Gynecol Oncol. 1989 Nov;35(2):219-23. doi: 10.1016/0090-8258(89)90047-4. PMID 2807013