Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXin Cai
About this trial
Prospective phase II clinical study aim to explore the clinical outcome of patients with unresectable locally recurrent rectal cancer (LRRC) treated with re-irradiation by carbon ion radiotherapy (CIRT)
Eligibility criteria
Qualifiers
1) pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and LRRC confirmed by biopsy or clinical diagnosis,
2) received a radical operation for their primary tumor and regional lymph nodes,
3) received chemo-radiation or radiation in pelvic before CIRT,
4) received re-irradiation by CIRT after their pelvic radiotherapy.
Disqualifiers
1) received more than once prior radiotherapy in the same treatment field,
2) time to the last radiotherapy was <1 year,
3) space between the lesion to organ at risk (OARs) (bladder or digestive tract) was too close (<5 mm).
Trial design
Treatments tested in this trial
- Carbon ion radiation therapy DT: 74Gy/20 fractions
Treatment groups
31 Participants
are divided into 1 treatment groupSponsors and collaborators
Xin Cai
Lead sponsor
Shanghai Proton and Heavy Ion Center
Sponsor institution
Source ClinicalTrials.gov