Primary
Objective
- Rate of complete or near complete clinical response
rate of the primary rectal tumors at 12 weeks. After pathology confirmed rectal cancer patients with predefined
inclusion criteria will be identified and all patients will be registered in
the study. Neoadjuvantchemoradiation
All patients will receive neoadjuvant chemoradiotherapy. Radiotherapy
to the pelvis will be delivered by 3DCRT or IMRT technique to a dose of
45-50Gy/25#/5weeks.
Radiotherapy will be accompanied by Tab Capecitabine (CAPE) 825 mg
/ m2 / B.I.D orally during the entire radiotherapy treatment course over 5
weeks
Radiotherapy techniques
Modality- All patients will be treated with megavoltage
photons. This includes Cobalt-60 or >4 MV obtained from a linear
accelerator.
Immobilization-Patients may be supine or prone (prone position is recommended,
preferably using a belly board).
CT simulation for 3-D planning- CT-based 3-D treatment planning
will be done for all cases.
Evaluation
and boost treatment
Within 1 week of completing EBRT (6th-7th week) all
patients will be assessed for radiotherapy boost by digital rectal examination
(DRE).
Endorectalbrachyboostwill
be given with high dose rate using Ir192 boost of 4-6Gy/# for 2 # once weekly(2
weeks).
For patients
not fit for endorectalbrachy boost EBRT boost of 9Gy in 4# will be given.
3.4 Evaluation at 6 weeks
post Radiotherapy
Response to neoadjuvant treatment will be assessed by DRE, MRI at
6-8 weekspost brachytherapy or EBRT (not receiving brachytherapy).
If the response is poor after neoadjuvant therapy, patients will undergo
standard surgical treatment.For patients who show nCR (near complete response having minimal
residual disease or residual scarring with complete
response on MRI) or cCR (clinical
complete response having no residual disease on DRE and MRI), there will be a
second reassessment at 11-12 weeks after the end of chemoradiotherapy. At the
end of this second reassessment, the patient will be offered the rectum-sparing
protocol if it shows nCR or cCR,
otherwise it will be a candidate for conventional surgery (TME).
Complete
Clinical Response- 1. DRE- Normal
2.
Endoscopy- White Scar with telangiectasia without palpable abnormalities
3. Absence
of residual tumor on T2W MRI with low signal intensity at the former tumor
location on DWI-MRI and the absence of suspicious nodes on T2W-MRI.
Near Complete
Response-1.DRE-Superficial soft irregularity, flat ulcer less than 2 cm at DRE
2.Endoscopy-
small residual flat ulcer, or irregular wall thickening.
3.
Obvious downstaging with/without residual fibrosis, but with a heterogeneous or
irregular aspect on MRI and/or a small focal area of high signal on
DWI-MRI
Patients in organ
preserving strategy will be subjected to a strict follow up schedule and
assessment. The enrolled patients will be assessed 3 monthly by clinical and
endoscopic examination and MRI for 2 years thereafter 6 monthly for upto 5
years.
Radical TME surgery will be performed in
patients having partial response post
8-12 weeks of neoadjuvant treatment. They will undergo regular follow up as per
institutional protocol.
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