title: Extended-field irradiation and intracavitary brachytherapy combined with cisplatin chemotherapy for cervical cancer with positive para-aortic or high common iliac lymph nodes: results of ARM 1 of RTOG 0116.
abstract: OBJECTIVE
  The Radiation Therapy Oncolology Group (RTOG) 0116 trial was designed to test the ability of Amifostine to reduce the toxicity of combined chemotherapy with extended-field radiotherapy and brachytherapy (Part 2), after first determining the toxicity rate for the regimen without Amifostine (Part 1). This manuscript reports the results of Part 1.
  
  
  METHODS
  Eligibility included patients with cervical carcinoma and high common iliac or para-aortic metastasis. Patients received extended-field radiotherapy to 45 Gy (1.8 Gy/fraction) with intracavitary irradiation. The final point A dose was 85 Gy LDR equivalent. Use of HDR was allowed. The positive para-aortic and high common iliac nodes were boosted to 54 to 59.4 Gy. Cisplatin (40 mg/m(2)) was delivered weekly during external beam and once with brachytherapy. The primary endpoint of Part 1 was acute Grade 3/4 toxicity, excluding Grade 3 leukopenia.
  
  
  RESULTS
  A total of 26 eligible patients were entered between August 1, 2000, and December 3, 2003. Of these, 21 had para-aortic metastasis (15 also had high common iliac involvement), and 5 had high common iliac involvement only. The median follow-up was 17.1 months (range, 1.8-38.6 months) for all patients and 21.7 months (range, 11.4-38.6 months) for alive patients. The acute Grade 3/4 toxicity rate, excluding Grade 3 leukopenia was 81%. Late Grade 3/4 toxicity was 40%. Eight patients underwent surgery for complications. Sixteen (62%) patients had a complete response for both local and nodal disease. The complete local response was 92%, the complete overall nodal response rate was 62% and the regional and para-aortic nodal response rates were 60% and 71% respectively. Estimated disease-free and overall survival at 18 months are 46% and 60%.
  
  
  CONCLUSIONS
  Extended field and intracavitary irradiation with cisplatin for para-aortic or high common iliac metastasis from cervical cancer is associated with significant acute and late toxicity.
authors.affiliation: Department of Radiation Oncology, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, 251 E. Huron Street, Chicago, IL 60611, USA. w-small@northwestern.edu
authors.forename: William
authors.initials: W
authors.lastname: Small
authors.forename: Kathryn
authors.initials: K
authors.lastname: Winter
authors.forename: Charles
authors.initials: C
authors.lastname: Levenback
authors.forename: Revathy
authors.initials: R
authors.lastname: Iyer
authors.forename: David
authors.initials: D
authors.lastname: Gaffney
authors.forename: Sucha
authors.initials: S
authors.lastname: Asbell
authors.forename: Beth
authors.initials: B
authors.lastname: Erickson
authors.forename: Anuja
authors.initials: A
authors.lastname: Jhingran
authors.forename: Kathy
authors.initials: K
authors.lastname: Greven
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000556:secondary; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods; D018196:Carcinoma, Adenosquamous / Q000188:drug therapy / Q000532:radiotherapy / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy / Q000556:secondary; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy / Q000009:adverse effects / Q000379:methods; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D011838:Radiation-Sensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use; D011878:Radiotherapy / Q000009:adverse effects / Q000379:methods; D011879:Radiotherapy Dosage; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*
chemical_list: D000970:Antineoplastic Agents; D011838:Radiation-Sensitizing Agents; D002945:Cisplatin