Comparison of pathologic response & safety in standard neoadjuvant therapy versus concomitant boost radiotherapy in patient with localy advanced rectal cancer reffered to cancer institute from 2021 to 2024.
Assesment of pathologic response and adverse effect
Design
Controlled clinical trial with parallel, randomized, phase two groups on 100 patients, randomization with sealed envelope.
Settings and conduct
The first group:radiotherapy in two phases with a dose of 45 Gy to the pelvis and 4.5 Gy to GTV, and the involved nodes received chemotherapy at the same time as capitabine on radiotherapy days and underwent reevaluation and surgery after 12-10 weeks. Patients between chemoradiotherapy and surgery Patients undergo chemotherapy (2course ,every three weeks) with the xelox.Chemotherapy is continued with the Xelox after surgery(for six months)In the second group, the chemotherapy regimen is similar to the first group, and in radiotherapy, in addition to the dose of 4500 cGy per pelvis, the patient receives 1100 cGy dose of concomitant boost (220 cGy on the sixth day of each week).The boost dose is given to the GTV and the lymph nodes involved plus a margin of one to two centimeters.The study will be conducted at the Cancer Institute of Tehran.
Participants/Inclusion and exclusion criteria
KPS> 70; T3&4N0 and 12 cm from anal verge and T2N0 in 5 cm from AV and Node + without metastasis; metastasis; failure to receive a full chemotherapy and radiotherapy regimen; receiving chemotherapy before radiotherapy and recurrence
Intervention groups
The first group: radiotherapy in two phases with a dose of 45 Gy to the pelvis and 4.5 Gy to GTV, and the involved nodes .In the second group in radiotherapy, in addition to the dose of 4500 cGy per pelvis, the patient receives 220 cGy on the sixth day of each week. The boost is given to the GTV and the lymph node involved plus a margin of one to two cm.
Main outcome variables
Pathological response, clinical response according to MRI and toxicity of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211108052999N1
Registration date:2021-11-25, 1400/09/04
Registration timing:registered_while_recruiting
Last update:2021-11-25, 1400/09/04
Update count:0
Registration date
2021-11-25, 1400/09/04
Registrant information
Name
Mehdi Aghili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2585
Email address
aghili@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2024-04-03, 1403/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pathologic response & safety in standard neoadjuvant therapy versus concomitant boost radiotherapy in patient with localy advanced rectal cancer reffered to cancer institute from 2021 to 2024.
Public title
Comparison of pathologic response & safety in standard neoadjuvant therapy versus concomitant boost radiotherapy in patient with localy advanced rectal cancer.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Good performance (kps> 70)
T3,T4 N0 in 12 of anal verge
Node+
T2N0 in 5 cm of anal verge
No metastasis
Exclusion criteria:
Incomplete chemotherapy or radiotherapy
Recurrence
Chemotherapy before radiotherapy
Metastasis
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, block randomization list created by sealed envelope website in two group with 4, 6, 8 block size
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Imam Khomeini hospital Ethics Committee of research
Street address
Imam Khomeini hospital complex, Tehran University of Medical Science (ethics committee)
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2021-11-02, 1400/08/11
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.235
Health conditions studied
1
Description of health condition studied
Rectal cancer
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum
Primary outcomes
1
Description
Pathologic response
Timepoint
After surgery
Method of measurement
Tissue pathological assesment
2
Description
Treatment adverse effect
Timepoint
Weekly during treatment
Method of measurement
Examination, CBC and renal function test
Secondary outcomes
1
Description
Clinical response
Timepoint
Before intervention and before surgery
Method of measurement
MRI
Intervention groups
1
Description
Intervention group: In intervention group, the chemotherapy regimen is similar to the first group, and in radiotherapy, in addition to 4500 cGy per pelvis, the patient receives 1100 cGy dose of concomitant boost (220 cGy on the sixth sixth day of each week). The following complications are evaluated weekly according to the CTC-AE NCI VERSION 4.0 guideline: Rectitis Diarrhea Dermatitis Hematologic complications Post-op complications for one month after surgery including wound problems, abscesses, ostomy problems, ...
Category
Treatment - Other
2
Description
Control group: in this group standard treatment including two-phase radiotherapy with a dose of 4500 cGy to pelvis and 540 cGy dose of boost to GTV and nodes involved and concomitant chemotherapy with capcitabine at a dose of 825 mg / m² / bd on radiotherapy days and after 12-10 weeks. And surgery. Between chemoradiotherapy and surgery, patients undergoing chemotherapy (every three weeks) are on the following regimen: xelox (capecitabine 1000 mg / m², oxaliplatin 130 mg / m²). Reassessment is performed immediately before surgery by pelvic MRI. Chemotherapy is continued with the Xelox diet. The total duration of chemotherapy before and after surgery is six months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Radition oncology ward in cancer institute/ imam khomeini hospital complex