Locally advanced rectal cancer
Conditions
Interventions
Photon therapy group:Short-course photon radiotherapy
Proton therapy group:Short-course proton radiotherapy
Sponsors
Shanghai Proton Heavy Ion Hospital/ The Clinical Technology Research And Development Center of Shanghai Proton and Heavy Ion Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 18~80 years old (including equal to); 2.Pathologically confirmed adenocarcinoma of the rectum (mucinous adenocarcinoma, signet ring cell carcinoma); 3.cT3-4?N+, stage II/III rectal cancer; 4.PET/CT is required to rule out distant metastases; 5.No prior radiation therapy within the scope of treatment; 6.ECOG 0-2 or KPS = 70; 7.Signed informed consent to receive radiotherapy;
Exclusion criteria
Exclusion criteria: 1.Patients with no clear pathology; 2.Distant metastases are detected prior to treatment; 3.Unable to tolerate or cooperate with the treatment due to physical and mental conditions; 4.Previous radiation therapy in the treatment area; 5.Dose limits for endangered organs cannot be reached to pre-set safe dose limits; 6.Treatment area contains metal implants, etc., which affect radiation therapy and cannot be circumvented; 7.KPS 2; 8.Concomitant severe comorbidities that may affect the delivery of radiotherapy, including: a) unstable angina requiring hospitalization, congestive heart failure, myocardial infarction in the past 6 months b) acute bacterial or systemic fungal infection c) exacerbation of chronic obstructive pulmonary disease or other respiratory diseases requiring hospitalization d) immunosuppressed patients e) concomitant connective tissue disease such as active scleroderma or contraindication to radiation therapy such as lupus; 9.Inability to understand the purpose of treatment or unwillingness to sign the treatment consent form; 10.Lack of capacity for civil conduct or limited capacity for civil conduct;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5 years locoregional relapse-free survival, 5y-LRRFS;Overall survival, OS;Disease-free survival, DFS;Acute (within 3 months) adverse reactions and late (more than 3 months) adverse reactions after radiotherapy;Quality of life,QOL; | — |
Countries
China
Contacts
Public ContactZhang Zhen, Xin Cai
Shanghai Proton Heavy Ion Hospital/ The Clinical Technology Research And Development Center of Shanghai Proton and Heavy Ion Center
Outcome results
None listed