Rectal Sparing Approach After Preoperative Radio and/or Chemotherapy in Patients With Rectal Cancer (ReSARCh)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02710812|
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : March 21, 2016
The proposed study is an observational, prospective, multicenter study of patients undergoing neoadjuvant therapy for medium-low rectal cancer.
Recently the investigators have published the findings of a multicenter Italian phase II study showing that the rate of local recurrence, with a 3 year follow-up, is less than 5% in patients with baseline T2-3 mid-low rectal cancer who, after preoperative chemoradiotherapy (pCRT), showed a major clinical response and underwent a transanal local excision. Based on these results, an organ-sparing approach for patients showing a major clinical response is feasible without reducing the good results obtained with the standard treatment. While a phase III trial is the best way to compare the standard treatment with the organ-sparing approach (local excision or wait-and-see) it is impracticable and likely unethical. An observational study is therefore one of the best way to evaluate the impact that an organ-sparing approach may have on oncological outcomes, quality of life, and bowel function for patients with rectal cancer who, after a pCRT, show a clinical major/complete response.
This phase II trial is designed to test the hypothesis that conservative treatments, in patients with low-mid rectal cancer who undergo a major or complete clinical response after neoadjuvant treatment, will be safe and effective compared to standard surgery.
The investigators will compare rectum-sparing approaches to standard surgery, firstly in terms of rate of organ preservation at 2 years. Additionally they will compare survival outcomes (DFS, OS), stoma rates, clinical and tumor factors related to pathological complete response, correlation between major and complete clinical response.
To add value, the investigators will measure QoL in patients treated with rectum-sparing approaches in comparison to patients treated with standard surgery (TME or abdomino-perineal amputation).
Rectum-sparing approach can be considered clinically acceptable if percentage of conservation of the rectum at two years is not less than 50%.
The collected data on 164 patients who underwent "rectum-sparing" allow to test the hypothesis that the rectum is preserved in 60% of patients with 80% power (exact binomial test for proportions, alpha = 5 %, 1 tail) and the study will be considered positive if it obtains a frequency of conservation of the rectum of not less than 87 cases.
The analysis results will be reported in accordance with STROBE guidelines (von Elm et al., 2008). For all analyzes, continuous variables are described using the mean and standard deviation of position and appropriate measures when appropriate. Categorical variables will be described using the contingency tables.
|Condition or disease||Intervention/treatment|
|Rectal Neoplasms||Procedure: Local Excision or Wait-and-See|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||164 participants|
|Official Title:||Rectal Sparing Approach After Preoperative Radio and/or Chemotherapy in Patients With Rectal Cancer|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||August 2021|
Rectum sparing group
Patients who have all of the following requirements:
Note: They will be subject to wait-and-see approach only patients with cCR.
Procedure: Local Excision or Wait-and-See
Local excision can be done both with traditional technique and with endoscopic technique (TEM, TAMIS, etc.).
The following principles should be respected:
- Rate of organ preservation [ Time Frame: 2 years ]The primary objective of th study is to determine the rate of organ preservation at 2 years in patients with rectal cancer treated with neoadjuvant therapy followed by conservative treatment (LE and wait-and-see).
- Rate of overall survival (OS) [ Time Frame: 2, 3, 5 years ]Rate of overall survival (OS) at 2, 3, and 5 years after initiation of treatment
- Rate of disease-free survival (DFS) [ Time Frame: 2, 3, 5 years ]Rate of disease-free survival (DFS) at 2, 3, and 5 years after initiation of treatment
- Rate of relapse-free local recurrence [ Time Frame: 2, 3, 5 years ]Rate of relapse-free local recurrence at 2, 3, and 5 years after initiation of treatment
- Rate of patients without stoma [ Time Frame: 2, 5 years ]Rate of patients without stoma at 2 and at 5 years
- Rate of pCR [ Time Frame: At surgery time ]Rate of pCR in patients who are treated with LE and with conventional surgery (TME);
- Morbidity [ Time Frame: 30 days after surgery ]Morbidity after neoadjuvant therapy and conservative approach or TME
- Mortality [ Time Frame: 30 days after surgery ]Mortality after neoadjuvant therapy and conservative approach or TME
- Rate of patients undergoing conservative treatment [ Time Frame: 5 years ]Rate of patients undergoing conservative treatment on total patients running pRT and/or CT
- Memorial Sloan-Kettering Cancer Center Bowel Function Instrument [ Time Frame: T0: before neoadjuvant treatment; T1: at 10-12 weeks after neoadjuvant treatment; T2: 6 months after T1; T3: 12 months after T1 ]MSKCC Bowel Function Instrument (Temple et al., 2005). The questionnaire consists of 18 items that include three subscales (frequency, dietary and urgency/soiling), four individual items of clinical significance ranging (incomplete emptying after a bowel movement, a second bowel movement within 15 min, knowing the difference between gas and bowel movement, inability to control the passage of flatus), and one total score obtained by the sum for all 18 items. Responses to individual items are given on a 5-point Likert scale with the first item (daily frequency of bowel movements) response divided into quintiles. Higher scores indicate better bowel function. The questionnaire has been translated and validated for Italian-speaking patients (Zotti et al., 2011).
- Fecal Incontinence Quality of Life Scale [ Time Frame: T0: before neoadjuvant treatment; T1: at 10-12 weeks after neoadjuvant treatment; T2: 6 months after T1; T3: 12 months after T1 ]FIQL (Rockwood et al., 2000). The questionnaire measures specific quality of life issues expected to affect patients with faecal incontinence. This instrument is composed of 29 items within four domains: lifestyle issues, coping/behaviour, depression/self-perception and embarrassment. The scores range from a minimum score of 1 to a maximum of 4, for all of the scales. The Italian version of the questionnaire has been validated by Altomare et al. (2004).
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 [ Time Frame: T0: before neoadjuvant treatment; T1: at 10-12 weeks after neoadjuvant treatment; T2: 6 months after T1; T3: 12 months after T1 ]EORTC QLQ-C30 (Aaronson et al., 1993). The questionnaire assesses health status and quality of life of cancer patients using 30 items grouped in one global scale, five multi-item functioning scales (physical, role, social, emotional, and cognitive functions), three symptom scales (fatigue, nausea/vomiting and pain) and six single symptom items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial impact). The items are scored on a four-point Likert scale with higher scores indicating a better level of functioning or a higher level of symptoms. The validity and reliability of the Italian versions of the questionnaire have been established (Apolone et al., 1998).
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Colorectal Cancer Module 29 [ Time Frame: T0: before neoadjuvant treatment; T1: at 10-12 weeks after neoadjuvant treatment; T2: 6 months after T1; T3: 12 months after T1 ]EORTC QLQ-CR29 (Whistance et al., 2009). The questionnaire measures health-related quality of life in patients with colorectal cancer, using 29 items grouped in four functional scale (body image, anxiety, weight, sex interest men/woman) and 18 symptom scale (urinary frequency, blood and mucus in stool, stool frequency, urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, impotence, dyspareunia). The items are scored on a four-point Likert scale with higher scores indicating a better level of functioning or a higher level of symptoms. The Italian version of the questionnaire is validated and widely used (Whistance et al.,2009).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710812
|Contact: Salvatore Pucciarelli, MD||39 firstname.lastname@example.org|
|Clinica Chirurgica I - Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche. Azienda Ospedaliera - Università di Padova||Recruiting|
|Padova, Italy, 35128|
|Contact: Salvatore Pucciarelli, MD +39 0498212208 email@example.com|
|Contact: Mariasole Bigon +39 0498211237 firstname.lastname@example.org|
|Principal Investigator: Salvatore Pucciarelli, MD|
|Sub-Investigator: Isacco Maretto, MD|
|Principal Investigator:||Salvatore Pucciarelli, MD||University of Padova|