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Prospective Pilot Study of Therapeutic Targets (TT) Tailored Chemotherapy (Ch) and Intensity Modulated Radiotherapy (IMRT) as Neoadjuvant Treatment in Patients With Rectal Carcinoma


N/A
18 Years
N/A
Not Enrolling
Both
Rectal Cancer

Thank you

Trial Information

Prospective Pilot Study of Therapeutic Targets (TT) Tailored Chemotherapy (Ch) and Intensity Modulated Radiotherapy (IMRT) as Neoadjuvant Treatment in Patients With Rectal Carcinoma


The parameter that best correlates with DFS in patients (pts) with localized rectal cancer
(RC) is the pathological TNM staging (ypTNM) after chemo-radiotherapy (Ch-RT).Tumor
regression grading (TRG) after Ch-RT has been correlated with DFS , 86% for TRG 4, 75% for
grouped TRG 2 + 3, and 63% for grouped TRG 0 + 1 but this is not as good as ypTNM to predict
pts outcome.

Standard 5-FU or capecitabine Ch-RT achieves 15% of ypCR with diarrhea and proctitis as the
main grade 3 toxicities in the range of 10-15% . With the combination of oxaliplatin and
capecitabine pCR rates are the same but the toxicity is the range of 25%. IMRT studies
reported 30% ypCR but with 30-40% grade 3 toxicities Last years strategies have explored
ways to integrate additional chemotherapeutic agents as capecitabine , oxaliplatin,
irinotecan, bevacizumab and cetuximab in Ch-RT regimens and to find biomarkers of their
effectiveness , but always in a retrospective way.

Our hypothesis is that with the actual knowledge and technology, a prospective tailored
chemotherapy selection in combination with IMRT is feasible and could improve the outcome of
patients with rectal cancer.


Inclusion Criteria:



- Histologic diagnosis of rectal adenocarcinoma.

- Clinical stage II or III.

- Feasible patient for neoadjuvant Ch-RT.

- Availability of tumor tissue or possibility of a tumor biopsy to define therapeutic
targets.

- Informed written consent was obtained from all patients

Exclusion Criteria:

- Contraindication to the administration of any of the drugs used in the study
capecitabine, irinotecan, oxaliplatin, cetuximab or bevacizumab.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

ypTN

Outcome Description:

pathology TN after neoadjuvant treatment and surgery

Outcome Time Frame:

Up to 1 month

Safety Issue:

No

Principal Investigator

Antonio Cubillo, MD.PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centro Integral Oncol├│gico Clara Campal

Authority:

Spain: Agencia Espa├▒ola de Medicamentos y Productos Sanitarios

Study ID:

62 202-878

NCT ID:

NCT01366118

Start Date:

October 2009

Completion Date:

April 2011

Related Keywords:

  • Rectal Cancer
  • Rectal cancer, Chemoradiotherapy, target therapy
  • Carcinoma
  • Rectal Neoplasms

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