Functional Outcome of Organ Preservation After Neo-adjuvant Chemo Radiation for Rectal Cancer

NCT02278653 | Unknown

• 1 other identifier: NL49171.068.14
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to describe the functional outcome of patients that choose for organ saving treatment.

Conditions

Rectal Neoplasms

Keywords

Restaging; Watchful Waiting; Quality of Life; Manometry

Outcome Measures

Primary Outcomes (1)

• Functional outcome

  Functional outcome scores of patients that are treated with an organ saving strategy compared to patients who undergo the standard resection as described in literature. Functional outcome will be evaluated with the following questionnaires: 1. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire, version 3.0, Global Quality of Life Score 2. Short Form (36) health survey 3. EORTC CR38 4. Vaizey score 5. Low Anterior Resection Syndrome (LARS) score 6. International Index of Erectile Function for men 7. International Prostate Symptom Score for men 8. Female Sexual Function Index for women Functional outcome will be measured by manometric measurements: 1. mean basal pressure (mmH2O) 2. maximum squeeze pressure (mmH2O) 3. first sensation (mL) 4. first urge to defecate (mL) 5. maximum tolerable volume (mL)

  5 years

Secondary Outcomes (5)

• Cumulative risk of local failure

  5 years

• Cumulative risks of disease-free, distant-metastasis free and overall survival

  5 years

• The percentage of patients that choose the alternative strategies instead of traditional strategies and the motivation for their choice

  3 years

• The compliance to the intensive follow-up schedule

  5 years

• Early detection of local failure (standard surgery still possible)

  5 years

Study Arms (1)

Study group

The population will consist of patients, aged 18 years or older, with locally advanced rectal cancer who after chemoradiation have a clinical complete response (ycT0N0) or very good response (ycT1-2N0).

Other: Questionnaires for the evaluation of Quality of Life; Other: Manometry

Interventions

Questionnaires for the evaluation of Quality of Life OTHER

1. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire, version 3.0, Global Quality of Life Score 2. Short Form (36) health survey 3. EORTC CR38 4. Vaizey score 5. Low Anterior Resection Syndrome (LARS) score 6. International Index of Erectile Function for men 7. International Prostate Symptom Score for men 8. Female Sexual Function Index for women

Study group

Manometry OTHER

Manometry is a tool to measure the anal sphincter function. Patients do not need any bowel preparation before this procedure. During the examination a catheter tip will be positioned in the rectum above the sphincter and a small balloon will be inflated. This balloon is connected to a device that registers the measurements. Patients will receive instructions; e.g. squeeze, push, and cough. The procedure takes approximately 10 minutes and is not experienced as painful. Several parameters will be measured: the mean basal pressure, the maximum squeeze pressure, first sensation, first urge to defecate and the maximum tolerable volume. The manometric measurement will take place on the same day as the endoscopy and MRI (standard follow-up).

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population will consist of patients, aged 18 years or older, with locally advanced rectal cancer who after chemoradiation have a clinical complete response (ycT0N0) or very good response (ycT1-2N0). Patients will be recruited from the outpatient clinic, by researchers or research nurses at Maastricht University Medical Center.

You may qualify if:

• years old
• Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response :
• Clinical complete response (ycT0N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI)
• Very good response (ycT1-2N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI). These patients will undergo a TEM to resect the small residual tumor
• Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient
• Choosing for the organ-saving treatment option (wait\&see policy or TEM)
• Informed consent

You may not qualify if:

• Unable to understand or read Dutch
• Unwilling to comply to the questionnaires or manometric measurement.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Dutch Cancer Society: collaborator

Study Sites (1)

MUMC+

Maastricht, 6202 AZ, Netherlands

Location

Related Publications (10)

• Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewe KW, Buijsen J, Beets GL. Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer. J Clin Oncol. 2011 Dec 10;29(35):4633-40. doi: 10.1200/JCO.2011.37.7176. Epub 2011 Nov 7.

  PMID: 22067400 BACKGROUND

• Maas M, Nelemans PJ, Valentini V, Das P, Rodel C, Kuo LJ, Calvo FA, Garcia-Aguilar J, Glynne-Jones R, Haustermans K, Mohiuddin M, Pucciarelli S, Small W Jr, Suarez J, Theodoropoulos G, Biondo S, Beets-Tan RG, Beets GL. Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data. Lancet Oncol. 2010 Sep;11(9):835-44. doi: 10.1016/S1470-2045(10)70172-8. Epub 2010 Aug 6.

  PMID: 20692872 BACKGROUND

• Habr-Gama A, Perez RO, Proscurshim I, Campos FG, Nadalin W, Kiss D, Gama-Rodrigues J. Patterns of failure and survival for nonoperative treatment of stage c0 distal rectal cancer following neoadjuvant chemoradiation therapy. J Gastrointest Surg. 2006 Dec;10(10):1319-28; discussion 1328-9. doi: 10.1016/j.gassur.2006.09.005.

  PMID: 17175450 BACKGROUND

• Lambregts DM, Beets GL, Maas M, Kessels AG, Bakers FC, Cappendijk VC, Engelen SM, Lahaye MJ, de Bruine AP, Lammering G, Leiner T, Verwoerd JL, Wildberger JE, Beets-Tan RG. Accuracy of gadofosveset-enhanced MRI for nodal staging and restaging in rectal cancer. Ann Surg. 2011 Mar;253(3):539-45. doi: 10.1097/SLA.0b013e31820b01f1.

  PMID: 21239980 BACKGROUND

• Lambregts DM, Vandecaveye V, Barbaro B, Bakers FC, Lambrecht M, Maas M, Haustermans K, Valentini V, Beets GL, Beets-Tan RG. Diffusion-weighted MRI for selection of complete responders after chemoradiation for locally advanced rectal cancer: a multicenter study. Ann Surg Oncol. 2011 Aug;18(8):2224-31. doi: 10.1245/s10434-011-1607-5. Epub 2011 Feb 23.

  PMID: 21347783 BACKGROUND

• Curvo-Semedo L, Lambregts DM, Maas M, Thywissen T, Mehsen RT, Lammering G, Beets GL, Caseiro-Alves F, Beets-Tan RG. Rectal cancer: assessment of complete response to preoperative combined radiation therapy with chemotherapy--conventional MR volumetry versus diffusion-weighted MR imaging. Radiology. 2011 Sep;260(3):734-43. doi: 10.1148/radiol.11102467. Epub 2011 Jun 14.

  PMID: 21673229 BACKGROUND

• Habr-Gama A, Perez RO, Wynn G, Marks J, Kessler H, Gama-Rodrigues J. Complete clinical response after neoadjuvant chemoradiation therapy for distal rectal cancer: characterization of clinical and endoscopic findings for standardization. Dis Colon Rectum. 2010 Dec;53(12):1692-8. doi: 10.1007/DCR.0b013e3181f42b89.

  PMID: 21178866 BACKGROUND

• Lambregts DM, Maas M, Bakers FC, Cappendijk VC, Lammering G, Beets GL, Beets-Tan RG. Long-term follow-up features on rectal MRI during a wait-and-see approach after a clinical complete response in patients with rectal cancer treated with chemoradiotherapy. Dis Colon Rectum. 2011 Dec;54(12):1521-8. doi: 10.1097/DCR.0b013e318232da89.

  PMID: 22067180 BACKGROUND

• Geubels BM, Maas M, Beets GL, Grotenhuis BA; Dutch Watch-and-Wait Consortium. What To Do With Suspected Nodal Regrowth on MRI During Follow-Up in an Organ Preservation Approach for Rectal Cancer? Dis Colon Rectum. 2024 Dec 1;67(12):1528-1535. doi: 10.1097/DCR.0000000000003385. Epub 2024 Sep 6.

  PMID: 39250317 DERIVED

• Haak HE, Zmuc J, Lambregts DMJ, Beets-Tan RGH, Melenhorst J, Beets GL, Maas M; Dutch Watch-and-Wait Consortium. The evaluation of follow-up strategies of watch-and-wait patients with a complete response after neoadjuvant therapy in rectal cancer. Colorectal Dis. 2021 Jul;23(7):1785-1792. doi: 10.1111/codi.15636. Epub 2021 Apr 2.

  PMID: 33725387 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Surveys and Questionnaires; Manometry

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Geerard L Beets, MD, PhD

  Surgery, MUMC+

  PRINCIPAL INVESTIGATOR

• Rianne CJ Beckers, MD, MSc

  Surgery/Radiology MUMC+

  STUDY CHAIR

• Miriam M van Heeswijk, MD, MSc

  Surgery/Radiology MUMC+

  STUDY CHAIR

• Monique Maas, MD, PhD

  Radiology, MUMC+

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 30, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: September 1, 2022
• Last Updated: September 18, 2019

Record last verified: 2019-09

Locations

NL (1)