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Digestive System Diseases

Carcinoma

Rectal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colorectal Neoplasms

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Gastrointestinal Diseases

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Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Antimetabolites

Patients who will be treated with

* radiotherapy 50 Gy in 25 fractions of 2 Gy, five times per week, over a period of 5 weeks associated with
* oral capecitabine 800 mg/m2 twice daily from the first day of radiotherapy and given 5 days per week during radiotherapy.

The surgery will be planned 7 weeks (±1 week) after the end of preoperative treatment

Patients who will be treated with radiotherapy 25 Gy in 5 fractions of 5 Gy delivered in one week (short-course arm) without chemotherapy.

The surgery will be planned 7 weeks (±1 week) after the end of preoperative treatment

radiotherapy 50 Gy in 25 fractions of 2 Gy, five times per week, over a period of 5 weeks

50 Gy

oral capecitabine 800 mg/m2 twice daily from the first day of radiotherapy and given 5 days per week during radiotherapy.

radiotherapy 25 Gy in 5 fractions of 5 Gy delivered in one week (short-course arm)

25 Gy

Eric Francois

The purpose of the study is to compare pre-operative radio-chemotherapy (RT + capecitabine) to a short course RT associated with a delayed surgery, with two primary objectives: the efficacy evaluation (rate of R0 resection) and the preservation of autonomy (score IADL).

Colorectal cancer is one of the most frequent cancers diagnosed in France. The average age of diagnosis in 2012 was 70 years old for men and 73 years for women, confirming that colorectal cancer is a disease of the elderly population.

The literature concerning combined treatments of colorectal cancer in the elderly is extremely limited. The application of combined treatments in the geriatric population is associated with an increase in the therapeutic complications. These post-operative complications together with the comorbidities and age are unfavorable prognostic factors for survival in patients with cancer of the rectum; this explains why the improved results obtained during the last decades are perceptible in younger patients and not in the elderly.

In the general population, pre-operative radio-chemotherapy has imposed itself as a standard treatment for the cancer of the rectum locally advanced. The utilization of fluoropyrimidines associated with radiotherapy (RT) delivered in fractions \[long course RT (50 Gy in 5 weeks), surgery planned 6 to 8 weeks later\] increases the complete histological response rate and decreases significantly the rate of local relapse.

The short-course RT \[short course RT using the Swedish model (5x5 Gy in 5 days), with the surgery programmed the following week\] is the standard neoadjuvant protocol in an important number of countries and/or academic groups. The studies that have compared the fractioned RT scheme to the short-course RT protocols have not shown any evidence of a change in efficacy of the short course RT concerning the following criteria: rate of R0 resection, rate of sphincter conservation, rate of relapse at 3 years, the disease free survival or the overall survival. Similarly, there appears to be no difference in severe toxicities in the long term. It should however be noted that short-course RT followed by immediate surgery may be less efficient than combined treatment in patients with a distal T3 cancer, even though these conclusions published by Ngan have been criticized by certain. On the other hand, the fractioned combined treatments results in more tumor and stage reduction and thus more sterilization.

Nevertheless a retrospective analysis, performed in the Stockholm region, in patients irradiated with short-course protocol but operated with a delay of at least 4 weeks resulted in a sterilization rate of 8%. This result is even more interesting since in this cohort, 46% of the patients had a tumor classified T4 and that 38% of the patients had a primitive tumor considered inoperable.

In the elderly population, the neoadjuvant treatment has rarely been studied. An exploratory analysis of the PRODIGE 2 study, based on age as the criteria, has shown that pre-operative radio-chemotherapy is significantly more toxic in the elderly population, from 70 years of age. Globally the lower tolerance for the pre-operative radio-chemotherapy results in more frequent early termination of RT and a statistically significant decrease in the number of patients operated. Furthermore, if the type of surgery was not significantly different between patients \<70 years and those ≥70 years, we observe a non-significant increase in the rate of prolonged stoma (patients amputated without closure of the stoma). These differences in the surgical procedures is also observed in other publications, placing the emphasis on the fact that in the absence of any difference in the clinical presentation or the characteristic of the tumor, the risk of real or supposed decompensation modifies the surgical care. These data, as well as those in the literature, provides evidence that the pre-operative radio-chemotherapy strategy followed by surgery, the standard strategy in younger patients, is associated with more side effects in the elderly, resulting in the benefit-risk balance, in this population, to be more questionable.

It is therefore necessary to conduct a specific studies in the elderly population, with cancer of the rectum with the objective to maintain the carcinological results obtained with classical radio-chemotherapy with at the same time better controlling the secondary effects of the treatment and the risk of decompensation of the patients: the short course radiotherapy associated with a delayed surgery may be a therapeutic scheme well adapted to this population.

The investigators therefore propose a study comparing pre-operative radio-chemotherapy (RT + capecitabine) to a short course RT associated with a delayed surgery, with two primary objectives: the efficacy evaluation (rate of R0 resection) and the preservation of autonomy (score IADL).

Neoadjuvant Treatment for Advanced Rectal Carcinoma

A Phase III Study Evaluating Two Neoadjuvant Treatments Radiochemotherapy (5 Weeks - 50Gy+Capecitabine) and Radiotherapy (1week - 25Gy) in Patient Over 75 With Locally Advanced Rectal Carcinoma

Compare the efficacy between the arm A and the arm B (with an objective of non-inferiority)

Compare the maintenance of autonomy between the arm A and arm B (with an objective of superiority)

Description of the Adverse Events during the pre-operative period.

according to Dindo-Clavien classification

Death rate is defined as the percentage of patients who died since the date of randomisation at 6 and 12 months post-surgery (M6 and M12) from any cause

The OS is defined as the interval between the date of randomization and the date of deaths from any cause

The specific survival is defined as the interval between the date of randomization and the date of deaths due to cancer.

The disease free survival is defined as the interval between the date of randomization and the date of cancer relapse (local regional or distant), second cancer or death from any cause.

The disease free survival is defined as the interval between the date of randomization and the date of cancer relapse (local or regional).

percentage of patients with definitive or transitional stoma after surgery.

UNICANCER

Behaviors and Mental Disorders

Quality of Life

Patients where it is possible to perform an anterior resection

Patients with locally advanced rectal cancer

Eva Angenete, M.D., Ph.D.

Rectal cancer is a common type of cancer occuring more frequently in men but also common in women. Almost 60% of the patients survive 5-years and the treatment has been continuously developed in the last three decades. The aim of the QoLiRECT study is to increase the knowledge about symptoms, functional impairments, quality of life (QoL) and psychological and socioeconomic burden in an unselected population of rectal cancer patients.

Rectal cancer is more frequent in men than in women and is relatively uncommon before the age of 50. The prognosis for rectal cancer has improved over the last decades2. Almost 60% of all patients survive more than five years, and because of advances in early detection and treatment, this number is expected to increase in the future1. Treatment of rectal cancer varies depending on the stage of the disease at diagnosis. For some patients, operation is the only treatment. For others, surgery is combined with radiotherapy, chemotherapy or both. The two most common operative procedures are the sphincter-preserving anterior resection (AR) and the abdominoperineal resection (APR) - the latter results in a permanent colostomy. Patients with generalised disease at diagnosis receive palliative treatment, which may include chemotherapy and radiotherapy as well as surgery.

Rectal cancer comes with a high risk of local recurrence, i.e. return of the tumour within the pelvis after a presumed curative resection. Local recurrence is difficult to treat and often very painful and distressing for the patient. Some local recurrences will be candidates for second line surgery, as is also true for some distant metastases.

The aim of the QoLiRECT study is to increase the knowledge about symptoms, functional impairments, quality of life (QoL) and psychological and socioeconomic burden in an unselected population of rectal cancer patients. Symptoms such as incontinence, pain, fatigue and impaired sexual function3 are common with this disease. Bodily changes, caused by the treatment or the disease itself, may lead to functional impairments and psychological, social, emotional and economical restraints. Conventional outcome measures such as morbidity and survival reveal little about these things.

Quality of Life in RECTal Cancer - a Prospective Multicenter Cohort Study

Quality of Life in RECTal Cancer - A Study Within the Scandinavian Surgical Outcomes Research Group

It will be evaluated at diagnosis, , i.e. at presentation of a plan for the treatment, at 12 months after start of the treatment, regardless of which, at 24 months after start of the treatment and at 60 months after start of the treatment

and at 12 months, 36 months and 60 monts after diagnosis

will also be assessed at 12 months after start of the treatment, regardless of which, at 24 months after start of the treatment and at 60 months after start of the treatment

and at 12 months after start of the treatment, regardless of which, at 24 months after start of the treatment and at 60 months after start of the treatment

This will be analyzed regardless of which, at 24 months after start of the treatment and at 60 months after start of the treatment

May be another time frame than the one registered. Depends on results from the QoL questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Treatment for Advanced Rectal Carcinoma	NCT02551237	Rectal Carcinom...	50 Gy Capecitabine 25 Gy	75 Years -	UNICANCER
Quality of Life in RECTal Cancer - a Prospective Multicenter Cohort Study	NCT01477229	Rectal Cancer Quality of Life Surgery		18 Years -	Sahlgrenska University Hospital, Sweden
Quality of Life in RECTal Cancer - a Prospective Multicenter Cohort Study	NCT01477229	Rectal Cancer Quality of Life Surgery		18 Years -	Sahlgrenska University Hospital, Sweden

Spots Global Cancer Trial Database for radio chemotherapy