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NCT Number: NCT05495308

"Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and Pathologic Complete Response After Neoadjuvant Treatment. Results From an Observational Retrospective Multicenter Long-term Follow-up Study".

Pathologic complete response (pCR) after multimodal treatment for locally advanced rectal cancer (LARC) patients is considered as the gold-standard of treatment success as it is associated to privileged oncologic outcome. Nevertheless, data from multicenter high-volume cohorts with long term follow-up are scarce.

This is a multicenter observational study using prospectively collected data from the Spanish Rectal Cancer Project database.

The main objective of the study is to update long-term oncologic follow-up of those patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.

Secondary objective is to analyze demographic, clinical, operative and treatment variables in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.

The results are reported in accordance with the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) Statement for observational studies.

All calculations are performed using Stata 13.1 (StataCorp, Texas, USA).

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Key information

Conditions

Rectal Cancer, Adenocarcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Distant Metastasis Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Local Recurrence of Malignant Tumor of Rectum Neoplasms Neoplasms by Site Rectal Cancer Stage II Rectal Cancer Stage III Rectal Diseases Rectal Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital La Princesa

Madrid, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with pathological confirmation of rectal cancer preoperatively, in any of its histological variants.
  • Tumor located less than 12 cm from the anal margin.
  • Radiological stage II or III (cT3-4 N0 and/or any T with positive cN).
  • Neoadjuvant treatment with radio-chemotherapy.
  • Radical surgery performed on a scheduled basis and with curative intent.
  • Definitive pathology study with complete tumor regression.

Exclusion criteria

  • Patients operated on with palliative intent.
  • Patients diagnosed with a hereditary colorectal cancer syndrome.
  • Patients who presented synchronous metastases at the time of diagnosis, or concurrent malignancy of another origin.
  • Patients who underwent emergency surgery.

Treatment and study plan

neoadjuvant treatment

Procedure

We study the number of patients who achive a complete pathological response after neoadjuvant treatment with radiochemotherapy.

Primary outcomes

  1. The main objective of the study is to update long-term oncologic follow-up of those patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.

    Time frame: May 2022-June 2022

    Patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.

Secondary outcomes

  1. To analyze operative and treatment data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.

    Time frame: May 2022-June 2022

    Operative and treatment data related to adverse oncologic outcomes.

  2. To analyze demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.

    Time frame: May 2022-June 2022

    Age (years) related to worse long-term oncologic outcomes.

  3. To analyze further demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.

    Time frame: May 2022-June 2022

    Normal Pretreatment CEA (ng/dl) related to worse long-term oncologic outcomes.

  4. To analyze clinical data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.

    Time frame: May 2022-June 2022

    Tumour location (cm) and Distance from anal verge (cm) related to worse long-term oncologic outcomes.

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Registry information

Official study title

Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and pCR After Neoadjuvant Treatment.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2022
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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