Timing for Rectal Surgery After Chemoradiotherapy

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• Rectal Neoplasms 1,760

Keywords

• Rectal cancer
• Chemoradiotherapy
• Surgery

Study arms

• No intervention
  Group 1

  The cancer surgery is practice 8 weeks after neoadjuvant chemoradiotherapy

• Experimental
  Group 2

  The cancer surgery will be performed in 12 weeks after neoadjuvant chemoradiotherapy

  Procedure: Surgery after 12 weeks of delay after chemoradiotherapy.

Interventions

• ProcedureSurgery after 12 weeks of delay after chemoradiotherapy.

  Surgery consists oncologic resection of the rectal cancer with total excision of the mesorectum after 12 weeks of delay after the end of chemoradiotherapy.

Primary outcomes

1. Complete pathologic response assessed by pathologist Dworak scale

   Dworak scale assesses the response: 0. No regression; 1. Predominantly tumor with significant fibrosis and/or vasculopathy; 2. Predominantly fibrosis with scattered tumor cells (slightly recognizable histologically); 3. Only scattered tumor cells in the space of fibrosis with/without acellular mucin; 4. No vital tumor cells detectable

   Time frame: 6 months

Secondary outcomes

1. Clinical response assessed using MRi

   Rates of clinical response to chemoradiotherapy before surgery, comparison between the two groups

   Time frame: 8 weeks (2 months)

2. Pathological response assessed by pathologist using Dworak scale

   Dworak scale assesses the response: 0. No regression; 1. Predominantly tumor with significant fibrosis and/or vasculopathy; 2. Predominantly fibrosis with scattered tumor cells (slightly recognizable histologically); 3. Only scattered tumor cells in the space of fibrosis with/without acellular mucin; 4. No vital tumor cells detectable

   Time frame: 6 months

3. Incidence of Treatment-Emergent Adverse Events as assessed by Clavien-Dindo scale

   Rates of operative morbidity at 30 days, comparison between the two groups. Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusionsand total parenteral nutritionare also included. Grade III Requiring surgical, endoscopic or radiological intervention * IIIa Intervention not under general anesthesia * IIIb Intervention under general anesthesia Grade IV Life-threatening complication (including CNS complications)\* requiring IC/ICU-management * IVa single organ dysfunction (including dialysis) * IVb multiorgan dysfunction

   Time frame: 30 days

4. Incidence of Mortality assessed by Clavien-Dindo scale

   Rates of operative mortality at 30 days, comparison between the two groups. Grade V Death of a patient

   Time frame: 30 days

5. Total mesorectal excision (TME) quality assessed by TME completeness scale (by P.Quircke)

   Quality of mesorectum resection assessed by TME completeness scale: 1. Mesorectal resection (MRR)/good/complete: intact mesorectum and smooth mesorectal surface with only minor irregularities; no defects deeper than 5 mm; no coning of the specimen towards the distal margin; and smooth macro-circular resection margin (CRM) on slicing. 2. Intramesorectal resection (IMR)/intermediate/nearly complete: intermediate bulk of the mesorectum with an irregular surface; a defect deeper than 5 mm, and no visible muscularis propria other than inserted levator; intermediate coning; intermediate irregularity of macro-CRM on slicing. 3. Muscularis propria resection (MPR)/poor/incomplete: small bulk of the mesorectum with a very irregular surface; defect down to the muscularis propria; severe coning; severe irregularity of macro-CRM on slicing.

   Time frame: 8-12 weeks

6. Distant recurrence assessed by CT scan

   Distant recurrence rates, comparison between the two groups

   Time frame: 5 years

7. Local recurrence assessed by CT scan/MRI/endoscopy

   Local recurrence rates, comparison between the two groups

   Time frame: 5 years

8. Oncological outcome - overall survival

   Overall survival rates, comparison between the two groups

   Time frame: 5 years

9. Oncological outcome - disease-free survival

   Disease-free survival rates, comparison between the two groups

   Time frame: 5 years

10. Radiotherapy skin toxicity assessed by EORTC scale

    Radiotherapy related toxicity rates: skin reactions will be assessed using EORTC radiotherapy toxicity scale: Skin Grade 1 follicular, faint or dull erythema / epilation / dry desquamation / decreased sweating; Grade 2 tender or bright erythema, patchy moist desquamation / moderate edema; Grade 3 confluent, moist desquamation other than skin folds, pitting edema; Grade 4 - ulceration, hemorrhage, necrosis

    Time frame: 5 years

11. Radiotherapy toxicity assessed by EORTC scale

    Radiotherapy related toxicity rates: gastrointestinal reactions will be assessed using EORTC radiotherapy toxicity scale: Grade 1 increased frequency or change in quality of bowel habits not requiring medication / rectal discomfort not requiring analgesics; Grade 2 diarrhea requiring parasympatholytic drugs (e.g. Lomotil) / mucous discharge not necessitating sanitary pads / rectal or abdominal pain requiring analgesics; Grade 3 diarrhea requiring parenteral support / severe mucous or blood discharge necessitating sanitary pads / abdominal distention (flat plate radiograph demonstrates distended bowel loops); Grade 4 acute or subacute obstruction, fistula or perforation; GI bleeding requiring transfusion; abdominal pain or tenesmus requiring tube decompression or bowel diversion

    Time frame: 5 years

12. Quality of Life assessed by Low anterior resection syndrome score

    The Low anterior resection syndrome score (LARS) score consists of five items concerning the following: incontinence for flatus, incontinence for liquid stool, frequency of bowel movements, clustering of stools, and urgency. Each symptom of bowel dysfunction is weighed according to its impact on the quality of life. The calculated score ranges from 0 to 42, with a score of 0-20 representing no ARS, a score of 21-29 representing minor ARS, and a score of 30-42 representing major ARS.

    Time frame: 1 year

13. Immune response assessed

    We have assessed the immune response before chemoradiotherapy and 8 weeks following the treatment. IL1B, IL6, IL8, IL10, IL2R, TNF alfa are assessed and will be correlated with the response to treatment.

    Time frame: 1 year

14. Urinary catheter removal timing

    All the patients will have there urinary catheters removed on day 1. Some patients will get Urorec (adrenomimetic for prevention of urinary retention). The patients will be randomized 2:1

    Time frame: 3 months