the Re-irradiation of Recurrent Cervical Cancer by IMRT

NCT03170570 | Unknown DMC

• 1 other identifier: RRTCC2017
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cervical Cancer; Radiation Toxicity; Recurrent Cervical Carcinoma

Keywords

recurrent cervical cancer; re-irradiation; intensity-modulated radiotherapy

Outcome Measures

Primary Outcomes (1)

• 3 year progression free survival (PFS)

  3 year progression free survival

  evaluate the response every 3 months since the completion of treatment until the progression of disease or death of patient up to 36 months

Secondary Outcomes (1)

• 3 year recurrence free survival ( RFS)

  evaluate the response every 3 months since the completion of treatment until the recurrence of disease or death of patient up to 36 months

Other Outcomes (1)

• 3 year overall survival ( OS)

  evaluate the response every 3 months since the completion of treatment until the death of patient up to 36 months

Study Arms (1)

treatment

EXPERIMENTAL

retreatment using intensity-modulated radiotherapy for cervical cancer patients with in-field recurrence

Device: intensity-modulated radiotherapy

Interventions

intensity-modulated radiotherapy DEVICE

IMRT: intensity modulated radiotherapy, Treatment schedule: 4-7 weeks, 20-35 fractions, unless the stop indications were met, treatment will continue.

treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (6)

• Andreu-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 BACKGROUND

• Timmer 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 BACKGROUND

• Mayr 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 BACKGROUND

• Look 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 BACKGROUND

• Potter 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 BACKGROUND

• Anthopoulos 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 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Radiation Injuries

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• xinping cao, MD

  Sun Yat-sen University Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xinping cao, MD

CONTACT

(86)13602736388; caoxp@sysucc.org.cn

kai chen, MD

CONTACT

(86)13924254460; chenkai1@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 31, 2017
• Study Start: December 1, 2016
• Primary Completion: April 30, 2019
• Study Completion: January 31, 2020
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)