Abstract | BACKGROUND: METHODS: Patients with stage II/III rectal cancer were randomly allocated to receive either pelvic intensity-modulated radiation therapy (IMRT) of 50 Gy/25Fx concurrently with capecitabine and oxaliplatin (Arm A), or pelvic radiation of 50 Gy/25Fx with a concomitant boost of 5 Gy to the primary lesion, followed by a cycle of XELOX 2 weeks after the end of CRT (Arm B). All patients were planned to receive a definitive operation 8 weeks after the completion of CRT and a total of six perioperative chemotherapy cycles of capecitabine and oxaliplatin regardless of pathological result. Pathological complete response (ypCR) was the primary endpoint. RESULTS: From February 2010 to December 2011, 120 patients from three centers were enrolled in this study. Ninety-five percent patients completed a full-dose chemoradiotherapy as planning. Then 53 and 57 patients received a radical surgery, and 8 and 14 cases were confirmed as ypCR in two groups (P = 0.157). The other 10 patients failed to receive a definitive resection because of unresectable disease. Similar toxicities were observed between two groups and more incision healing delay were found in Arm B (3 vs.13, P = 0.011). No statistical differences were observed in local-regional control (P = 0.856), disease-free survival (P = 0.349) and overall survival (P = 0.553). Mesorectal fascia (MRF) involvement was an independent prognostic factor for survival in multivariate analysis. CONCLUSIONS: A concomitant boost to oxalipatin-combined preoperative chemoradiotherapy demonstrated a slightly higher pCR rate but delayed incision healing after surgery. The impact of MRF involvement on survival merits further investigations. TRIAL REGISTRATION: NCT01064999 (ClinicalTrials.gov).
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Authors | Jingwen Wang, Yun Guan, Weilie Gu, Senxiang Yan, Juying Zhou, Dan Huang, Tong Tong, Chao Li, Sanjun Cai, Zhen Zhang, Ji Zhu |
Journal | Radiation oncology (London, England)
(Radiat Oncol)
Vol. 14
Issue 1
Pg. 215
(Nov 29 2019)
ISSN: 1748-717X [Electronic] England |
PMID | 31783766
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Topics |
- Adenocarcinoma
(pathology, radiotherapy, therapy)
- Adolescent
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Chemoradiotherapy, Adjuvant
(mortality)
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Neoadjuvant Therapy
(mortality)
- Prognosis
- Radiotherapy, Intensity-Modulated
(mortality)
- Rectal Neoplasms
(pathology, radiotherapy, therapy)
- Survival Rate
- Young Adult
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