title: 3D conformal postoperative radiotherapy with concomitant boost in uterine cancer: results of a phase I-II study (ADA-RT-1).
abstract: OBJECTIVE
  A phase I-II prospective clinical trial of adjuvant accelerated radiation therapy (ADA-RT-1 trial) was set up in order to investigate the feasibility and efficacy of a pelvic conformal radiotherapy technique with concomitant boost (CB technique) to the vaginal vault in high-risk uterine cancers.
  
  
  METHODS
  Patients with uterine (endometrial cancer and sarcomas) and cervical neoplasm received external radiotherapy delivered in a short overall treatment time with a CB technique. The prescribed radiotherapy doses were 45/1.8 Gy/fraction to the pelvis and 55/2.2 Gy/fraction to the upper two-thirds of vagina plus resection lines in the parametria, respectively; treatment was administered in 25 fractions along 5 weeks.
  
  
  RESULTS
  This study included 91 consecutive gynecological cancer patients (endometrial=72; cervical=10; sarcoma=9; median follow-up: 25 months, range: 5-72 months). Acute toxicity requiring treatment interruption (≥grade 3) was observed in 7 patients (7.7%). No case of vaginal recurrence was documented. Actuarial 3-year loco-regional control rate was 97.7%, whereas 3-year disease-free survival and overall survival rates were 88.5% and 94.0%, respectively.
  
  
  CONCLUSIONS
  In summary, the CB technique provides a high probability of local control with acceptable toxicity and shortening of the overall treatment time; moreover, it may offer some advantages to resource constrained medical environments.
authors.affiliation: Radiotherapy Unit, Department of Oncology, John Paul II Center for High Technology Research and Education in Biomedical Sciences, Catholic University, Largo A. Gemelli 1, 86100, Campobasso, Italy. gmacchia@rm.unicatt.it
authors.forename: Gabriella
authors.initials: G
authors.lastname: Macchia
authors.forename: Gabriella
authors.initials: G
authors.lastname: Ferrandina
authors.forename: Francesco
authors.initials: F
authors.lastname: Deodato
authors.forename: Romina
authors.initials: R
authors.lastname: Bibbò
authors.forename: Mariangela
authors.initials: M
authors.lastname: Massaccesi
authors.forename: Edy
authors.initials: E
authors.lastname: Ippolito
authors.forename: Numa
authors.initials: N
authors.lastname: Cellini
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Valentini
authors.forename: Alessio Giuseppe
authors.initials: AG
authors.lastname: Morganti
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D020266:Radiotherapy, Conformal / Q000009:adverse effects; D014594:Uterine Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery